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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00847613




Registration number
NCT00847613
Ethics application status
Date submitted
17/02/2009
Date registered
19/02/2009
Date last updated
16/05/2024

Titles & IDs
Public title
A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Scientific title
Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Secondary ID [1] 0 0
A3921044
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 - CP-690,550
Treatment: Drugs - CP-690,550
Treatment: Drugs - Placebo
Treatment: Drugs - CP-690,550
Treatment: Drugs - Placebo
Treatment: Drugs - CP-690,550

Experimental: Sequence 1 -

Experimental: Sequence 2 -

Placebo comparator: Sequence 3 -

Placebo comparator: Sequence 4 -


Treatment: Drugs: CP-690,550
Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

Treatment: Drugs: CP-690,550
Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.

Treatment: Drugs: CP-690,550
Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

Treatment: Drugs: CP-690,550
Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.

Treatment: Drugs: Placebo
Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

Treatment: Drugs: CP-690,550
Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.

Treatment: Drugs: Placebo
Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

Treatment: Drugs: CP-690,550
Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.
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
Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6
Timepoint [2] 0 0
Baseline, Month 6
Primary outcome [3] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
Timepoint [3] 0 0
Baseline, Month 3
Primary outcome [4] 0 0
Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6
Timepoint [4] 0 0
Month 6
Secondary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3
Timepoint [1] 0 0
Month 1, 3
Secondary outcome [2] 0 0
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24
Timepoint [2] 0 0
Month 9, 12, 15, 18, 21, 24
Secondary outcome [3] 0 0
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6
Timepoint [3] 0 0
Month 1, 3, 6
Secondary outcome [4] 0 0
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24
Timepoint [4] 0 0
Month 9, 12, 15, 18, 21, 24
Secondary outcome [5] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6
Timepoint [5] 0 0
Month 1, 3, 6
Secondary outcome [6] 0 0
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24
Timepoint [6] 0 0
Month 9, 12, 15, 18, 21, 24
Secondary outcome [7] 0 0
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6
Timepoint [7] 0 0
Baseline, Month 1, 3, 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, 12, 15, 18, 21 and 24
Timepoint [8] 0 0
Month 9, 12, 15, 18, 21, 24
Secondary outcome [9] 0 0
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6
Timepoint [9] 0 0
Baseline, Month 1, 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 9, 12, 15, 18, 21 and 24
Timepoint [10] 0 0
Month 9, 12, 15, 18, 21, 24
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, Month 1, 3, 6, 9, 12, 15, 18, 21, 24
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 1, 3, 6, 9, 12, 15, 18, 21, 24
Secondary outcome [13] 0 0
Modified Total Sharp Scores (mTSS) at Baseline
Timepoint [13] 0 0
Baseline
Secondary outcome [14] 0 0
Modified Total Sharp Scores (mTSS) at Month 12 and 24
Timepoint [14] 0 0
Month 12, 24
Secondary outcome [15] 0 0
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6
Timepoint [15] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [16] 0 0
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24
Timepoint [16] 0 0
Month 9, 12, 15, 18, 21, 24
Secondary outcome [17] 0 0
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6
Timepoint [17] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [18] 0 0
Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24
Timepoint [18] 0 0
Month 9, 12, 15, 18, 21, 24
Secondary outcome [19] 0 0
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6
Timepoint [19] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [20] 0 0
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24
Timepoint [20] 0 0
Month 9, 12, 15, 18, 21, 24
Secondary outcome [21] 0 0
Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6
Timepoint [21] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [22] 0 0
Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24
Timepoint [22] 0 0
Month 9, 12, 15, 18, 21, 24
Secondary outcome [23] 0 0
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Timepoint [23] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [24] 0 0
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24
Timepoint [24] 0 0
Month 9, 12, 15, 18, 21, 24
Secondary outcome [25] 0 0
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Timepoint [25] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [26] 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 [26] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [27] 0 0
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24
Timepoint [27] 0 0
Month 12, 18, 24
Secondary outcome [28] 0 0
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24
Timepoint [28] 0 0
Month 12, 18, 24
Secondary outcome [29] 0 0
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6
Timepoint [29] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [30] 0 0
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24
Timepoint [30] 0 0
Month 12, 18, 24
Secondary outcome [31] 0 0
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6
Timepoint [31] 0 0
Baseline, Month 3, 6
Secondary outcome [32] 0 0
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24
Timepoint [32] 0 0
Month 12, 18, 24
Secondary outcome [33] 0 0
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6
Timepoint [33] 0 0
Baseline, Month 3, 6
Secondary outcome [34] 0 0
Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24
Timepoint [34] 0 0
Month 12, 18, 24
Secondary outcome [35] 0 0
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Timepoint [35] 0 0
Baseline, Month 3, 6
Secondary outcome [36] 0 0
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24
Timepoint [36] 0 0
Month 12, 18, 24
Secondary outcome [37] 0 0
Number of Events Including Visits, Surgeries, Tests or Devices 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 Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24
Timepoint [38] 0 0
Month 12, 18, 24
Secondary outcome [39] 0 0
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Timepoint [39] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [40] 0 0
Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24
Timepoint [40] 0 0
Month 12, 18, 24
Secondary outcome [41] 0 0
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Timepoint [41] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [42] 0 0
Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24
Timepoint [42] 0 0
Month 12, 18, 24
Secondary outcome [43] 0 0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Timepoint [43] 0 0
Baseline, Month 1, 3, 6
Secondary outcome [44] 0 0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24
Timepoint [44] 0 0
Month 12, 18, 24

Eligibility
Key inclusion criteria
* Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.

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
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
Accrual to date
Final
800
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Maroochydore
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Woodville
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Malvern East
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3145 - Malvern East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
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West Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Brazil
State/province [23] 0 0
GO
Country [24] 0 0
Brazil
State/province [24] 0 0
PR
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio Grande Do Sul
Country [26] 0 0
Brazil
State/province [26] 0 0
RJ
Country [27] 0 0
Brazil
State/province [27] 0 0
RS
Country [28] 0 0
Brazil
State/province [28] 0 0
SP
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Plovdiv
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Sofia
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
British Columbia
Country [33] 0 0
Canada
State/province [33] 0 0
Newfoundland and Labrador
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Colombia
State/province [36] 0 0
Antioquia
Country [37] 0 0
Colombia
State/province [37] 0 0
Atlantico
Country [38] 0 0
Colombia
State/province [38] 0 0
Cundinamarca
Country [39] 0 0
Colombia
State/province [39] 0 0
Santander
Country [40] 0 0
Czechia
State/province [40] 0 0
Brno - Zidenice
Country [41] 0 0
Czechia
State/province [41] 0 0
Brno
Country [42] 0 0
Czechia
State/province [42] 0 0
Hostivice
Country [43] 0 0
Czechia
State/province [43] 0 0
Pardubice
Country [44] 0 0
Czechia
State/province [44] 0 0
Praha 11 - Chodov
Country [45] 0 0
Czechia
State/province [45] 0 0
Praha 1
Country [46] 0 0
Czechia
State/province [46] 0 0
Praha 2
Country [47] 0 0
Czechia
State/province [47] 0 0
Zlin
Country [48] 0 0
Greece
State/province [48] 0 0
Thessaloniki
Country [49] 0 0
India
State/province [49] 0 0
Andhra Pradesh
Country [50] 0 0
India
State/province [50] 0 0
Andra Pradesh
Country [51] 0 0
India
State/province [51] 0 0
Karnataka
Country [52] 0 0
India
State/province [52] 0 0
Maharashtra
Country [53] 0 0
Japan
State/province [53] 0 0
Fukuoka
Country [54] 0 0
Japan
State/province [54] 0 0
Hiroshima
Country [55] 0 0
Japan
State/province [55] 0 0
Ibaraki
Country [56] 0 0
Japan
State/province [56] 0 0
Kanagawa
Country [57] 0 0
Japan
State/province [57] 0 0
Kumamoto
Country [58] 0 0
Japan
State/province [58] 0 0
Miyagi
Country [59] 0 0
Japan
State/province [59] 0 0
Nagasaki
Country [60] 0 0
Japan
State/province [60] 0 0
Saga
Country [61] 0 0
Japan
State/province [61] 0 0
Saitama
Country [62] 0 0
Japan
State/province [62] 0 0
Shizuoka
Country [63] 0 0
Japan
State/province [63] 0 0
Tokyo
Country [64] 0 0
Japan
State/province [64] 0 0
Shinjuku-ku, Tokyo
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Daejeon
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Incheon
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Seoul
Country [68] 0 0
Mexico
State/province [68] 0 0
DF
Country [69] 0 0
Mexico
State/province [69] 0 0
Michoacan
Country [70] 0 0
Poland
State/province [70] 0 0
Warszawa
Country [71] 0 0
Poland
State/province [71] 0 0
Wroclaw
Country [72] 0 0
Taiwan
State/province [72] 0 0
Kaohsiung
Country [73] 0 0
Taiwan
State/province [73] 0 0
Kweishan, Taoyuan County
Country [74] 0 0
Taiwan
State/province [74] 0 0
Taichung
Country [75] 0 0
Taiwan
State/province [75] 0 0
Tainan
Country [76] 0 0
Taiwan
State/province [76] 0 0
Taipei
Country [77] 0 0
Ukraine
State/province [77] 0 0
Crimea
Country [78] 0 0
Ukraine
State/province [78] 0 0
Kharkiv
Country [79] 0 0
Ukraine
State/province [79] 0 0
Kyiv
Country [80] 0 0
Ukraine
State/province [80] 0 0
Lviv
Country [81] 0 0
Ukraine
State/province [81] 0 0
Vinnitsa

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/NCT00847613