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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00856544




Registration number
NCT00856544
Ethics application status
Date submitted
3/03/2009
Date registered
5/03/2009
Date last updated
10/01/2013

Titles & IDs
Public title
A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications
Scientific title
Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS
Secondary ID [1] 0 0
A3921046
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo

Experimental: Active 5 mg -

Experimental: Active 10 mg -

Placebo comparator: Placebo Sequence 1 - Placebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit.

Placebo comparator: Placebo Sequence 2 - Placebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.


Treatment: Drugs: CP-690,550
Film coated tablet, 5 mg PO BID, 1 year

Treatment: Drugs: CP-690,550
Film coated tablet, 10 mg PO BID, 1 year

Treatment: Drugs: Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months

Treatment: Drugs: Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Timepoint [1] 0 0
Month 6
Primary outcome [2] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
Timepoint [2] 0 0
Baseline, Month 3
Primary outcome [3] 0 0
Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6
Timepoint [3] 0 0
Month 6
Secondary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6
Timepoint [1] 0 0
Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [2] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12
Timepoint [2] 0 0
Month 9, 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6
Timepoint [3] 0 0
Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [4] 0 0
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12
Timepoint [4] 0 0
Month 9, 12
Secondary outcome [5] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6
Timepoint [5] 0 0
Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [6] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12
Timepoint [6] 0 0
Month 9, 12
Secondary outcome [7] 0 0
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Timepoint [7] 0 0
Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [8] 0 0
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12
Timepoint [8] 0 0
Month 9, 12
Secondary outcome [9] 0 0
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6
Timepoint [9] 0 0
Baseline, Month 3, 6
Secondary outcome [10] 0 0
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12
Timepoint [10] 0 0
Month 12
Secondary outcome [11] 0 0
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Timepoint [11] 0 0
Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
Secondary outcome [12] 0 0
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
Timepoint [12] 0 0
Baseline, Month 3, 6, 12
Secondary outcome [13] 0 0
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Timepoint [13] 0 0
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [14] 0 0
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12
Timepoint [14] 0 0
Month 9, Month 12
Secondary outcome [15] 0 0
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Timepoint [15] 0 0
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [16] 0 0
Patient Assessment of Arthritis Pain at Month 9 and 12
Timepoint [16] 0 0
Month 9, 12
Secondary outcome [17] 0 0
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Timepoint [17] 0 0
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [18] 0 0
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
Timepoint [18] 0 0
Month 9, 12
Secondary outcome [19] 0 0
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Timepoint [19] 0 0
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Secondary outcome [20] 0 0
Physician Global Assessment (PGA) of Arthritis at Month 9 and 12
Timepoint [20] 0 0
Month 9, 12
Secondary outcome [21] 0 0
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Timepoint [21] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [22] 0 0
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Timepoint [22] 0 0
Month 9, 12
Secondary outcome [23] 0 0
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Timepoint [23] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [24] 0 0
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Timepoint [24] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [25] 0 0
Medical Outcome Study (MOS) Sleep Scale at Month 12
Timepoint [25] 0 0
Month 12
Secondary outcome [26] 0 0
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12
Timepoint [26] 0 0
Month 12
Secondary outcome [27] 0 0
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6
Timepoint [27] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [28] 0 0
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12
Timepoint [28] 0 0
Month 12
Secondary outcome [29] 0 0
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6
Timepoint [29] 0 0
Baseline, Month 3, 6
Secondary outcome [30] 0 0
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12
Timepoint [30] 0 0
Month 12
Secondary outcome [31] 0 0
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6
Timepoint [31] 0 0
Baseline, Month 3, 6
Secondary outcome [32] 0 0
Work Limitations Questionnaire (WLQ) Score at Month 12
Timepoint [32] 0 0
Month 12
Secondary outcome [33] 0 0
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Timepoint [33] 0 0
Baseline, Month 3, 6
Secondary outcome [34] 0 0
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Timepoint [34] 0 0
Month 12
Secondary outcome [35] 0 0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Timepoint [35] 0 0
Baseline, Month 3, 6
Secondary outcome [36] 0 0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
Timepoint [36] 0 0
Month 12
Secondary outcome [37] 0 0
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Timepoint [37] 0 0
Baseline, Month 3, 6
Secondary outcome [38] 0 0
Number of Days as Assessed Using RA-HCRU at Month 12
Timepoint [38] 0 0
Month 12
Secondary outcome [39] 0 0
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Timepoint [39] 0 0
Baseline, Month 3, 6
Secondary outcome [40] 0 0
Number of Hours Per Day as Assessed RA-HCRU at Month 12
Timepoint [40] 0 0
Month 12
Secondary outcome [41] 0 0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Timepoint [41] 0 0
Baseline, Month 3, 6
Secondary outcome [42] 0 0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
Timepoint [42] 0 0
Month 12

Eligibility
Key inclusion criteria
* The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
* The patient has active disease as defined by both >=4 tender or painful joints on motion and >= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL.
* Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
* Patient must remain on at least one background traditional disease modifying antirheumatic drug.
* No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L.
* History of any other rheumatic autoimmune disease other than Sjogren's syndrome.
* No malignancy or history of malignancy.
* History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
Accrual to date
Final
795
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Campsie
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Cairns
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Maroochydore
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Woodville
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Malvern East
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Shenton Park
Recruitment postcode(s) [1] 0 0
2194 - Campsie
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3145 - Malvern East
Recruitment postcode(s) [6] 0 0
6008 - Shenton Park
Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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Colorado
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Senica
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Distrito Capital

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00856544