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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00413699
Registration number
NCT00413699
Ethics application status
Date submitted
18/12/2006
Date registered
20/12/2006
Date last updated
30/10/2018
Titles & IDs
Public title
Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis
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Scientific title
A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis
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Secondary ID [1]
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2006-005035-19
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Secondary ID [2]
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A3921024
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Experimental: Open-Label Active Treatment Enrolled from Phase 2 - Patients enrolling from Phase 2 studies
Experimental: Open-Label Active Treatment Enrolled from Phase 3 - Patients enrolling from Phase 3 studies
Treatment: Drugs: CP-690,550
5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
Treatment: Drugs: CP-690,550
10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports
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Assessment method [1]
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Treatment-emergent non serious AEs by System Organ Class (SOC) (all causalities) and Laboratory Test Abnormalities (without regard to baseline) The stated number of participants analyzed was the total number of participants in each group (AEs). The actual number of participants analyzed for each laboratory parameter varied, and is provided for each.
Abs=absolute; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ESR=erythrocyte sedimentation rate; GGT=gamma glutamyl transferase; hgb=hemoglobin; HDL=high density lipids; LDL=low density lipids; LLN=lower limit of normal; qual=qualitative; Tot=total; ULN=upper limit of normal; WBC=white blood cell
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Timepoint [1]
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Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug
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Primary outcome [2]
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Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs)
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Assessment method [2]
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
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Timepoint [2]
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Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)
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Primary outcome [3]
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Extension Period: Number of Participants With Laboratory Test Abnormalities
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Assessment method [3]
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Criteria for laboratory abnormalities: hemoglobin (Hg), hematocrit, red blood cell (RBC), high density lipoprotein (HDL) cholesterol:\<0.8\*lower limit of normal (LLN), platelet\<0.5\*LLN/\>1.75\*upper limit of normal (ULN), white blood cell (WBC)\<0.6\*LLN/\>1.5\*ULN, lymphocyte, neutrophil, protein, albumin \<0.8\*LLN/\>1.2\*ULN, basophil, eosinophil, monocyte, low density lipoprotein (LDL) cholesterol: \>1.2\*ULN; bilirubin\>1.5\*ULN, aspartate amino transferase(AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:\>3.0\*ULN; blood urea nitrogen, creatinine, cholesterol, triglyceride:\>1.3\*ULN; sodium \<0.95\*LLN/\>1.05\*ULN, potassium, chloride, calcium, bicarbonate: \<0.9\*LLN/\>1.1\*ULN; glucose\<0.6\*LLN/\>1.5\*ULN; Urine (specific gravity\<1.003/\>1.030, pH\<4.5/\>8, glucose, ketone, protein, blood/Hg(\>=1; RBC, WBC\>=20; creatinine kinase\>2\*ULN).
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Timepoint [3]
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Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)
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Primary outcome [4]
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Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis
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Assessment method [4]
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Treatment-emergent AEs by SOC (all causalities) - all participants, by time. Data presented for Post Month 96 includes data up to and including Month 114.
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Timepoint [4]
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Includes AEs for every visit and up to 999 days after last dose of study drug
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Primary outcome [5]
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Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib
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Assessment method [5]
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Long term safety and tolerability of Tofacitinib was measured as following: percentage (%) of participants with AEs, percentage of participants who discontinued due to AEs. An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.
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Timepoint [5]
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Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period
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Secondary outcome [1]
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Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses
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Assessment method [1]
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The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented. ACR20 is defined as a 20% improvement from baseline in tender/painful joint count and swollen joint count, and at least 3 of the following 5 variables: Subject's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, Subject's Assessment of Arthritis Pain, Health Assessment Questionnaire - Disability Index, C-Reactive Protein (CRP). ACR50 is a 50% improvement and ACR70 a 70% improvement in these variables.
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Timepoint [1]
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Every visit until study completion
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Secondary outcome [2]
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Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses
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Assessment method [2]
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ACR20=20 percent (%) improvement from baseline (Month 0 at entry of Initial Period) in tender/painful joint count and swollen joint count, and in at least 3 of 5 variables: participant's global assessment of arthritis (PtGA), physician's global assessment of arthritis (PGA), participant's assessment of arthritis pain (PtA), HAQ-DI, C-reactive protein. ACR50 is a 50% improvement and ACR70 is a 70% improvement in these variables. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PtA: participant assessed arthritis pain by 100 millimeter (mm) visual analogue scale, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability.
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Timepoint [2]
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Month 3, 6, 9 and 12 of Extension Period
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Secondary outcome [3]
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Initial Period: Area Under American College of Rheumatology (ACR) n Curve
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Assessment method [3]
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No data were collected for this endpoint because it was removed from the protocol in a previous amendment.
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Timepoint [3]
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Not applicable as no data were collected for this endpoint.
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Secondary outcome [4]
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Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR])
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Assessment method [4]
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Descriptive statistics for DAS28-3 (CRP) and DAS28-4 (ESR). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.
DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.
The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of \>5.1 indicates active disease, a score of =3.2 indicates low disease activity, and a score of \<2.6 indicates disease remission.
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Timepoint [4]
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Every visit until study completion
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Secondary outcome [5]
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Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12
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Assessment method [5]
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DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR \[millimeter per hour\] or CRP \[milligram per liter\]). DAS28-4 also include score of general health (GH). GH is general health or participants' global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores = worse health condition). DAS28-3(CRP) = (0.56\*sqrt\[TJC28\] + 0.28\*sqrt\[SJC28\] + 0.36\*ln\[CRP+1\]) \*1.10 + 1.15) and DAS28-4(ESR) = (0.56\*sqrt\[TJC28\] + 0.28\*sqrt\[SJC28\] + 0.70\*ln\[ESR\] + 0.014\*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score ranges from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of \<=3.2 indicate low disease activity and score of \<2.6 indicate disease remission.
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Timepoint [5]
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Baseline (Month 0 at the entry of Initial period); Month 3, 6, 9 and 12 of Extension Period
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Secondary outcome [6]
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Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and =3.2
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Assessment method [6]
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Percent participants with DAS28-4 (ESR) \<2.6 and =3.2 and percent participants with DAS28-3 (CRP) \<2.6 and =3.2. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.
DAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.
The score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of \>5.1 indicates active disease, a score of =3.2 indicates low disease activity, and a score of \<2.6 indicates disease remission.
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Timepoint [6]
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Every visit until study completion
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Secondary outcome [7]
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Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2
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Assessment method [7]
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DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR \[millimeter per hour\] or CRP \[milligram per liter\]). DAS28-4 also include score of GH. GH is general health or participants' global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores = worse health condition). DAS28-3(CRP) = (0.56\*sqrt\[TJC28\] + 0.28\*sqrt\[SJC28\] + 0.36\*ln\[CRP+1\]) \*1.10 + 1.15) and DAS28-4(ESR) = (0.56\*sqrt\[TJC28\] + 0.28\*sqrt\[SJC28\] + 0.70\*ln\[ESR\] + 0.014\*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score range is from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of \<=3.2 indicate low disease activity and score of \<2.6 indicate disease remission.
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Timepoint [7]
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Baseline (Day 1 at the entry of Extension period); Month 3, 6, 9 and 12 of Extension Period
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Secondary outcome [8]
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Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
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Assessment method [8]
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Change from baseline by visit. HAQ-DI scores range from 0 to 3, where lower score implies less disease. A reduction from baseline in score indicates an improvement in condition. A clinically meaningful decrease from baseline is defined as a decrease of at least 0.22 units. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.
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Timepoint [8]
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Every visit until study completion
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Secondary outcome [9]
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Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12
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Assessment method [9]
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HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities. Each activity category consisted of 2-3 questionnaire. Each questionnaire was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity that required assistance from another individual or required the use of an assistive device was adjusted to a score of 2 to represent a more limited functional status. Overall score was computed as the sum of total scores divided by the number of questionnaire answered. Total possible HAQ-DI score range: 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
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Timepoint [9]
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Baseline (Month 0 at the entry of Initial Period); Month 3, 6, 9, and 12 of Extension Period
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Secondary outcome [10]
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Initial Period: Short-Form-36 Health Survey (SF-36) Score
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Assessment method [10]
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Change from Baseline for Physical Component and Mental Component Scores by visit. SF-36 is a health status measure of 8 general health domains, each scored on a 0 to 100 scale: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These domains can be summarized as physical and mental component scores. The domain scores were "normed" and the resulting component scores treated as Z-scores with a scale of negative to positive infinity. A higher score implies less disease. The greater the change from baseline, the greater the improvement. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.
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Timepoint [10]
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Every visit until study completion
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Secondary outcome [11]
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Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU)
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Assessment method [11]
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Change from Baseline Scores for each: FACIT Fatigue Scale (score range 0 to 52, higher score indicates higher quality of life and an increase from baseline score indicates improvement), EuroQol EQ 5D (index values derived from a measure of central tendency and a measure of dispersion, an increase from baseline indicates improvement, score range 0 to 1), Work Limitations (WL) Physical Demands (covers ability to perform job tasks that involve bodily strength, a decrease from baseline indicates improvement, score range 0 to 100, higher scores indicating greater limitation), and RA Healthcare Resource Utilization Work Performance in Past 3 Months on Days Bothered by RA (assesses healthcare use over previous 3 months, a decrease from baseline indicates improvement, score range 0 to 10).
The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.
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Timepoint [11]
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Every visit until study completion
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Secondary outcome [12]
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Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study
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Assessment method [12]
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Modified Total Sharp Score per visit. Baseline score was the last available assessment from the index study. The Modified Total Sharp Score measures disease progression; increased scores indicate disease progression. Score range 0 (normal) to 448 (worst possible total score). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.
TSS=Total Sharp Score
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Timepoint [12]
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Every 6 months until study completion
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Secondary outcome [13]
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Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Pneumococcal Vaccine as Defined by = 2-fold Increase in Antibody Concentrations
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Assessment method [13]
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Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by =2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in =6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.
95% CI is based on Clopper-Pearson exact method for response rate.
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Timepoint [13]
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From vaccine sub-study visit 2 (baseline) to sub-study visit 4
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Secondary outcome [14]
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Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Seasonal Influenza Vaccine as Defined by = 4-fold Increase in Antibody Titers
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Assessment method [14]
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Number of participants achieving a satisfactory humoral response to the seasonal influenza vaccine as defined by =4-fold increase in antibody titers from visit 2 (vaccination baseline) in =2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.
95% CI is based on Clopper-Pearson exact method for response rate.
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Timepoint [14]
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From vaccine sub-study visit 2 (baseline) to sub-study visit 4
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Secondary outcome [15]
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Vaccine Sub-study. Percentage of Participants Achieving Protective Antibody Titers to the Seasonal Influenza Vaccine as Measured by a Hemagglutination Inhibition (HI) Assay Titer of = 1:40 in = 2 of 3 Influenza Antigens at Vaccine Sub-study Visit 3 and 4
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Assessment method [15]
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Number (%) of participants achieving protective antibody titers to the seasonal influenza vaccine as measured by an HAI assay titer of =1:40 in =2 of 3 influenza antigens measured at vaccine sub-study visits 3 and 4.
The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.
95% CI is based on Clopper-Pearson exact method for response rate.
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Timepoint [15]
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From vaccine sub-study visit 2 (baseline) to sub-study visit 4
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Secondary outcome [16]
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Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by = 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4
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Assessment method [16]
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Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by =2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in =6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.
95% CI is based on Clopper-Pearson exact method for response rate.
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Timepoint [16]
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From vaccine sub-study visit 2 (baseline) to sub-study visit 4
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Secondary outcome [17]
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Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 3 Influenza Antigens as Defined by = 4-fold Increase in Antibody Titers From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4
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Assessment method [17]
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Number (%) of participants achieving a satisfactory humoral response to the seasonal influenza vaccine defined as =4-fold increase in antibody titers from visit 2 (vaccination baseline) in =2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2).
The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.
95% CI is based on Clopper-Pearson exact method for response rate.
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Timepoint [17]
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From vaccine sub-study visit 2 (baseline) to sub-study visit 4
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Secondary outcome [18]
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Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4
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Assessment method [18]
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Geometric Mean Fold Increase From Baseline of Pneumococcal Antigens Measured at Visit 4.
n was the number of participants with valid and determinate assay results for the specified serotype at the given visit.
The stated number of participants analyzed was the total number of participants. The actual number of participants analyzed for some serotypes varied, and is provided where it differed from the total number of participants.
Confidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
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Timepoint [18]
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From vaccine sub-study visit 2 (baseline) to sub-study visit 4
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Secondary outcome [19]
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Vaccine Sub-study. Fold Increase of Anti-influenza Antibody Levels to Each of the 3 Influenza Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4
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Assessment method [19]
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Geometric Mean Fold Increase From Baseline of Influenza Antigens Measured at Visit 4.
n was the number of participants with valid and determinate assay results for the specified HAI strain at the given visit.
Confidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
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Timepoint [19]
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From vaccine sub-study visit 2 (baseline) to sub-study visit 4
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Secondary outcome [20]
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Vaccine Sub-study. Concentrations of Anti-pneumococcal Antibodies at Vaccine Sub-study Visit 3 and 4
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Assessment method [20]
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Mean pneumococcal concentrations (ug/mL) at vaccine baseline (visit 2) and post-vaccination visits (visits 3 and 4) by serotype. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed for each serotype varied, and is provided for each individually.
ug/mL=micrograms per milliliter
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Timepoint [20]
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From vaccine sub-study visit 2 (baseline) to sub-study visit 4
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Secondary outcome [21]
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Vaccine Sub-study. Titers of Anti-influenza Antibodies at Vaccine Sub-study Visit 3 and 4
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Assessment method [21]
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Mean influenza antibody titers at visits 3 and 4.
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Timepoint [21]
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From vaccine sub-study visit 2 (baseline) to sub-study visit 4
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Eligibility
Key inclusion criteria
* Subjects who have participated in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis
Vaccine sub-study visit
* Subjects actively participating in Study A3921024 must have completed at least 3 months of continuous 10 mg BID CP-690,550 treatment in A3921024 as defined by >80% compliance with prescribed dose consumption of CP-690,550 over the previous 3 months.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Serious medical conditions that would make treatment with CP-690,550 potentially unsafe
Vaccine sub-study visit
1. Any documented influenza or pneumococcal infection within the last 3 months prior to randomization in this study
2. Received any vaccine within 1 month prior to randomization in this study
3. Received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of randomization in this study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/02/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/10/2017
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Sample size
Target
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Accrual to date
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Final
4488
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Optimus Clinical Research Pty. Ltd. - Kogarah
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Recruitment hospital [2]
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Rheumatology Research - Cairns
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Recruitment hospital [3]
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Rheumatology Research Unit Sunshine Coast - Maroochydore
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Recruitment hospital [4]
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Queen Elizabeth Hospital, Department of Rheumatology - Woodville
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Recruitment hospital [5]
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Emeritus Research - Malvern East
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Recruitment hospital [6]
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Goatcher Clinical Research Unit - Perth
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Recruitment hospital [7]
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Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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4870 - Cairns
Query!
Recruitment postcode(s) [3]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [4]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [5]
0
0
3145 - Malvern East
Query!
Recruitment postcode(s) [6]
0
0
WA 6000 - Perth
Query!
Recruitment postcode(s) [7]
0
0
NSW2065 - St Leonards
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Delaware
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Florida
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Georgia
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Idaho
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Illinois
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Indiana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Iowa
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Kansas
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Kentucky
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Louisiana
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Maine
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Maryland
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Massachusetts
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Michigan
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Minnesota
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Mississippi
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Missouri
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Nebraska
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
New Hampshire
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
New Jersey
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
New York
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
North Carolina
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
North Dakota
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Ohio
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Oklahoma
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Pennsylvania
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
South Carolina
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Tennessee
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Texas
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Washington
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
West Virginia
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
Wisconsin
Query!
Country [39]
0
0
Argentina
Query!
State/province [39]
0
0
Caba
Query!
Country [40]
0
0
Argentina
Query!
State/province [40]
0
0
Buenos Aires
Query!
Country [41]
0
0
Austria
Query!
State/province [41]
0
0
Wien
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Oost-vlaanderen
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Kortrijk
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Liège
Query!
Country [45]
0
0
Bosnia and Herzegovina
Query!
State/province [45]
0
0
Sarajevo
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
GO
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Paraná
Query!
Country [48]
0
0
Brazil
Query!
State/province [48]
0
0
PR
Query!
Country [49]
0
0
Brazil
Query!
State/province [49]
0
0
RJ
Query!
Country [50]
0
0
Brazil
Query!
State/province [50]
0
0
RS
Query!
Country [51]
0
0
Brazil
Query!
State/province [51]
0
0
SP
Query!
Country [52]
0
0
Brazil
Query!
State/province [52]
0
0
Sao Paulo
Query!
Country [53]
0
0
Bulgaria
Query!
State/province [53]
0
0
Pleven
Query!
Country [54]
0
0
Bulgaria
Query!
State/province [54]
0
0
Plovdiv
Query!
Country [55]
0
0
Bulgaria
Query!
State/province [55]
0
0
Sevlievo
Query!
Country [56]
0
0
Bulgaria
Query!
State/province [56]
0
0
Sofia
Query!
Country [57]
0
0
Bulgaria
Query!
State/province [57]
0
0
Veliko Tarnovo
Query!
Country [58]
0
0
Canada
Query!
State/province [58]
0
0
Alberta
Query!
Country [59]
0
0
Canada
Query!
State/province [59]
0
0
British Columbia
Query!
Country [60]
0
0
Canada
Query!
State/province [60]
0
0
Manitoba
Query!
Country [61]
0
0
Canada
Query!
State/province [61]
0
0
Newfoundland and Labrador
Query!
Country [62]
0
0
Canada
Query!
State/province [62]
0
0
Ontario
Query!
Country [63]
0
0
Canada
Query!
State/province [63]
0
0
Quebec
Query!
Country [64]
0
0
Canada
Query!
State/province [64]
0
0
Saskatchewan
Query!
Country [65]
0
0
Chile
Query!
State/province [65]
0
0
IX Region
Query!
Country [66]
0
0
Chile
Query!
State/province [66]
0
0
Region Metropolitana
Query!
Country [67]
0
0
Chile
Query!
State/province [67]
0
0
Region XIV
Query!
Country [68]
0
0
Chile
Query!
State/province [68]
0
0
RM
Query!
Country [69]
0
0
Chile
Query!
State/province [69]
0
0
Santiago, RM
Query!
Country [70]
0
0
Chile
Query!
State/province [70]
0
0
Rancagua
Query!
Country [71]
0
0
Chile
Query!
State/province [71]
0
0
Santiago
Query!
Country [72]
0
0
Chile
Query!
State/province [72]
0
0
Vina Del Mar, V Region
Query!
Country [73]
0
0
China
Query!
State/province [73]
0
0
Beijing
Query!
Country [74]
0
0
China
Query!
State/province [74]
0
0
Guangdong
Query!
Country [75]
0
0
China
Query!
State/province [75]
0
0
Hubei
Query!
Country [76]
0
0
China
Query!
State/province [76]
0
0
Hunan
Query!
Country [77]
0
0
China
Query!
State/province [77]
0
0
Shaanxi
Query!
Country [78]
0
0
China
Query!
State/province [78]
0
0
Shandong
Query!
Country [79]
0
0
China
Query!
State/province [79]
0
0
Shanghai
Query!
Country [80]
0
0
China
Query!
State/province [80]
0
0
Chengdu
Query!
Country [81]
0
0
China
Query!
State/province [81]
0
0
Hangzhou
Query!
Country [82]
0
0
China
Query!
State/province [82]
0
0
Hefei
Query!
Country [83]
0
0
China
Query!
State/province [83]
0
0
Nanjing
Query!
Country [84]
0
0
China
Query!
State/province [84]
0
0
Suzhou
Query!
Country [85]
0
0
China
Query!
State/province [85]
0
0
Tianjin
Query!
Country [86]
0
0
Colombia
Query!
State/province [86]
0
0
Atlantico
Query!
Country [87]
0
0
Colombia
Query!
State/province [87]
0
0
Cundinamarca
Query!
Country [88]
0
0
Colombia
Query!
State/province [88]
0
0
Santander
Query!
Country [89]
0
0
Costa Rica
Query!
State/province [89]
0
0
Cartago
Query!
Country [90]
0
0
Costa Rica
Query!
State/province [90]
0
0
San Jose
Query!
Country [91]
0
0
Croatia
Query!
State/province [91]
0
0
Osijek
Query!
Country [92]
0
0
Croatia
Query!
State/province [92]
0
0
Split
Query!
Country [93]
0
0
Croatia
Query!
State/province [93]
0
0
Zagreb
Query!
Country [94]
0
0
Czechia
Query!
State/province [94]
0
0
Brno
Query!
Country [95]
0
0
Czechia
Query!
State/province [95]
0
0
Ceska Lipa
Query!
Country [96]
0
0
Czechia
Query!
State/province [96]
0
0
Ceske Budejovice
Query!
Country [97]
0
0
Czechia
Query!
State/province [97]
0
0
Hlucin
Query!
Country [98]
0
0
Czechia
Query!
State/province [98]
0
0
Hostivice
Query!
Country [99]
0
0
Czechia
Query!
State/province [99]
0
0
Hradec Kralove
Query!
Country [100]
0
0
Czechia
Query!
State/province [100]
0
0
Ostrava
Query!
Country [101]
0
0
Czechia
Query!
State/province [101]
0
0
Pardubice
Query!
Country [102]
0
0
Czechia
Query!
State/province [102]
0
0
Praha 11 - Chodov
Query!
Country [103]
0
0
Czechia
Query!
State/province [103]
0
0
Praha 2
Query!
Country [104]
0
0
Czechia
Query!
State/province [104]
0
0
Praha 4
Query!
Country [105]
0
0
Czechia
Query!
State/province [105]
0
0
Zlin
Query!
Country [106]
0
0
Denmark
Query!
State/province [106]
0
0
Frederiksberg
Query!
Country [107]
0
0
Dominican Republic
Query!
State/province [107]
0
0
Santo Domingo
Query!
Country [108]
0
0
Finland
Query!
State/province [108]
0
0
Helsinki
Query!
Country [109]
0
0
Finland
Query!
State/province [109]
0
0
Hyvinkaa
Query!
Country [110]
0
0
Finland
Query!
State/province [110]
0
0
Tampere
Query!
Country [111]
0
0
France
Query!
State/province [111]
0
0
Amiens
Query!
Country [112]
0
0
France
Query!
State/province [112]
0
0
Orleans
Query!
Country [113]
0
0
France
Query!
State/province [113]
0
0
Paris
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Aachen
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Berlin
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Dresden
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Erlangen
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Frankfurt am Main
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Halle
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Hamburg
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Herne
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Koeln
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Leipzig
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Muenchen
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Nuernberg
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Ratingen
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Rheine
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
Wuerzburg
Query!
Country [129]
0
0
Greece
Query!
State/province [129]
0
0
Thessaloniki
Query!
Country [130]
0
0
Hungary
Query!
State/province [130]
0
0
Balatonfured
Query!
Country [131]
0
0
Hungary
Query!
State/province [131]
0
0
Budapest
Query!
Country [132]
0
0
Hungary
Query!
State/province [132]
0
0
Szolnok
Query!
Country [133]
0
0
India
Query!
State/province [133]
0
0
Andhra Pradesh
Query!
Country [134]
0
0
India
Query!
State/province [134]
0
0
Gujarat
Query!
Country [135]
0
0
India
Query!
State/province [135]
0
0
Karnataka
Query!
Country [136]
0
0
India
Query!
State/province [136]
0
0
Maharashtra
Query!
Country [137]
0
0
India
Query!
State/province [137]
0
0
Telangana
Query!
Country [138]
0
0
Ireland
Query!
State/province [138]
0
0
Dublin
Query!
Country [139]
0
0
Italy
Query!
State/province [139]
0
0
FI
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
Genova
Query!
Country [141]
0
0
Korea, Republic of
Query!
State/province [141]
0
0
Incheon
Query!
Country [142]
0
0
Korea, Republic of
Query!
State/province [142]
0
0
Republic OF Korea
Query!
Country [143]
0
0
Korea, Republic of
Query!
State/province [143]
0
0
Busan
Query!
Country [144]
0
0
Korea, Republic of
Query!
State/province [144]
0
0
Daegu
Query!
Country [145]
0
0
Korea, Republic of
Query!
State/province [145]
0
0
Gwangju
Query!
Country [146]
0
0
Korea, Republic of
Query!
State/province [146]
0
0
Seoul,
Query!
Country [147]
0
0
Korea, Republic of
Query!
State/province [147]
0
0
Seoul
Query!
Country [148]
0
0
Malaysia
Query!
State/province [148]
0
0
Negeri Sembilan
Query!
Country [149]
0
0
Malaysia
Query!
State/province [149]
0
0
Sabah
Query!
Country [150]
0
0
Malaysia
Query!
State/province [150]
0
0
Sarawak
Query!
Country [151]
0
0
Malaysia
Query!
State/province [151]
0
0
Selangor
Query!
Country [152]
0
0
Malaysia
Query!
State/province [152]
0
0
Wilayah Persekutuan
Query!
Country [153]
0
0
Mexico
Query!
State/province [153]
0
0
BAJA California Norte
Query!
Country [154]
0
0
Mexico
Query!
State/province [154]
0
0
Coahuila
Query!
Country [155]
0
0
Mexico
Query!
State/province [155]
0
0
DF
Query!
Country [156]
0
0
Mexico
Query!
State/province [156]
0
0
Estado DE Mexico
Query!
Country [157]
0
0
Mexico
Query!
State/province [157]
0
0
Jalisco
Query!
Country [158]
0
0
Mexico
Query!
State/province [158]
0
0
Mexico D.F.
Query!
Country [159]
0
0
Mexico
Query!
State/province [159]
0
0
Michoacan
Query!
Country [160]
0
0
Mexico
Query!
State/province [160]
0
0
Morelos
Query!
Country [161]
0
0
Mexico
Query!
State/province [161]
0
0
Nuevo LEON
Query!
Country [162]
0
0
Mexico
Query!
State/province [162]
0
0
Yucatan
Query!
Country [163]
0
0
Mexico
Query!
State/province [163]
0
0
Chihuahua
Query!
Country [164]
0
0
Mexico
Query!
State/province [164]
0
0
Mexico City
Query!
Country [165]
0
0
Mexico
Query!
State/province [165]
0
0
Mexico, D.F.
Query!
Country [166]
0
0
Mexico
Query!
State/province [166]
0
0
Queretaro
Query!
Country [167]
0
0
Mexico
Query!
State/province [167]
0
0
San Luis Potosi
Query!
Country [168]
0
0
New Zealand
Query!
State/province [168]
0
0
Christchurch
Query!
Country [169]
0
0
New Zealand
Query!
State/province [169]
0
0
Hamilton
Query!
Country [170]
0
0
New Zealand
Query!
State/province [170]
0
0
Timaru
Query!
Country [171]
0
0
Peru
Query!
State/province [171]
0
0
Callao
Query!
Country [172]
0
0
Peru
Query!
State/province [172]
0
0
Lima
Query!
Country [173]
0
0
Philippines
Query!
State/province [173]
0
0
Batangas
Query!
Country [174]
0
0
Philippines
Query!
State/province [174]
0
0
Cavite
Query!
Country [175]
0
0
Philippines
Query!
State/province [175]
0
0
Pampanga
Query!
Country [176]
0
0
Philippines
Query!
State/province [176]
0
0
Cebu City
Query!
Country [177]
0
0
Philippines
Query!
State/province [177]
0
0
Davao City
Query!
Country [178]
0
0
Philippines
Query!
State/province [178]
0
0
Las Piñas City
Query!
Country [179]
0
0
Philippines
Query!
State/province [179]
0
0
Manila
Query!
Country [180]
0
0
Poland
Query!
State/province [180]
0
0
Bialystok
Query!
Country [181]
0
0
Poland
Query!
State/province [181]
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Funding & Sponsors
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Summary
Brief summary
The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550 A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550
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Trial website
https://clinicaltrials.gov/study/NCT00413699
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Trial related presentations / publications
Mueller RB, Schulze-Koops H, Furst DE, Cohen SB, Kwok K, Wang L, Killeen T, von Kempis J. Effect of dose adjustments on the efficacy and safety of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of an open-label, long-term extension study (ORAL Sequel). Clin Rheumatol. 2022 Apr;41(4):1045-1055. doi: 10.1007/s10067-021-05908-z. Epub 2022 Jan 1. Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6. Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395. van der Heijde D, Landewe RBM, Wollenhaupt J, Strengholt S, Terry K, Kwok K, Wang L, Cohen S. Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1708-1716. doi: 10.1093/rheumatology/keaa476. Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2021 Sep;66(9):3214-3215. doi: 10.1007/s10620-020-06638-z. Kaine J, Tesser J, Takiya L, DeMasi R, Wang L, Snyder M, Soma K, Fan H, Bandi V, Wollenhaupt J. Re-establishment of efficacy of tofacitinib, an oral JAK inhibitor, after temporary discontinuation in patients with rheumatoid arthritis. Clin Rheumatol. 2020 Jul;39(7):2127-2137. doi: 10.1007/s10067-020-04956-1. Epub 2020 Feb 12. Wollenhaupt J, Lee EB, Curtis JR, Silverfield J, Terry K, Soma K, Mojcik C, DeMasi R, Strengholt S, Kwok K, Lazariciu I, Wang L, Cohen S. Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study. Arthritis Res Ther. 2019 Apr 5;21(1):89. doi: 10.1186/s13075-019-1866-2. Li ZG, Liu Y, Xu HJ, Chen ZW, Bao CD, Gu JR, Zhao DB, An Y, Hwang LJ, Wang L, Kremer J, Wu QZ. Efficacy and Safety of Tofacitinib in Chinese Patients with Rheumatoid Arthritis. Chin Med J (Engl). 2018 Nov 20;131(22):2683-2692. doi: 10.4103/0366-6999.245157. Hall S, Nash P, Rischmueller M, Bossingham D, Bird P, Cook N, Witcombe D, Soma K, Kwok K, Thirunavukkarasu K. Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses in an Australian Rheumatoid Arthritis Population. Rheumatol Ther. 2018 Dec;5(2):383-401. doi: 10.1007/s40744-018-0118-2. Epub 2018 Jun 11. Fleischmann R, Wollenhaupt J, Takiya L, Maniccia A, Kwok K, Wang L, van Vollenhoven RF. Safety and maintenance of response for tofacitinib monotherapy and combination therapy in rheumatoid arthritis: an analysis of pooled data from open-label long-term extension studies. RMD Open. 2017 Dec 18;3(2):e000491. doi: 10.1136/rmdopen-2017-000491. eCollection 2017. Fleischmann R, Wollenhaupt J, Cohen S, Wang L, Fan H, Bandi V, Andrews J, Takiya L, Bananis E, Weinblatt ME. Effect of Discontinuation or Initiation of Methotrexate or Glucocorticoids on Tofacitinib Efficacy in Patients with Rheumatoid Arthritis: A Post Hoc Analysis. Rheumatol Ther. 2018 Jun;5(1):203-214. doi: 10.1007/s40744-018-0093-7. Epub 2018 Feb 7. Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2. Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31. Genovese MC, van Vollenhoven RF, Wilkinson B, Wang L, Zwillich SH, Gruben D, Biswas P, Riese R, Takiya L, Jones TV. Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis. Arthritis Res Ther. 2016 Jun 23;18:145. doi: 10.1186/s13075-016-1049-3. Winthrop KL, Silverfield J, Racewicz A, Neal J, Lee EB, Hrycaj P, Gomez-Reino J, Soma K, Mebus C, Wilkinson B, Hodge J, Fan H, Wang T, Bingham CO 3rd. The effect of tofacitinib on pneumococcal and influenza vaccine responses in rheumatoid arthritis. Ann Rheum Dis. 2016 Apr;75(4):687-95. doi: 10.1136/annrheumdis-2014-207191. Epub 2015 Mar 20. Boyle DL, Soma K, Hodge J, Kavanaugh A, Mandel D, Mease P, Shurmur R, Singhal AK, Wei N, Rosengren S, Kaplan I, Krishnaswami S, Luo Z, Bradley J, Firestein GS. The JAK inhibitor tofacitinib suppresses synovial JAK1-STAT signalling in rheumatoid arthritis. Ann Rheum Dis. 2015 Jun;74(6):1311-6. doi: 10.1136/annrheumdis-2014-206028. Epub 2014 Nov 14.
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Results are available at
https://clinicaltrials.gov/study/NCT00413699
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