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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01039688




Registration number
NCT01039688
Ethics application status
Date submitted
23/12/2009
Date registered
25/12/2009
Date last updated
6/04/2018

Titles & IDs
Public title
Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX
Scientific title
Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis
Secondary ID [1] 0 0
2009-016987-34
Secondary ID [2] 0 0
A3921069
Universal Trial Number (UTN)
Trial acronym
ORAL1069
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 - Disease-modifying antirheumatic drug

Experimental: 5 mg BID CP-690,550 -

Experimental: 10 mg BID CP-690,550 -

Active comparator: methotrexate -


Treatment: Drugs: CP-690,550
Oral tablets administered at a dose of 5 mg BID for 24 months

Treatment: Drugs: CP-690,550
Oral tablets administered at a dose of 10 mg BID for 24 months

Treatment: Drugs: Disease-modifying antirheumatic drug
Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Modified Total Sharp Score (mTSS) at Month 6
Timepoint [1] 0 0
Month 6
Primary outcome [2] 0 0
Change From Baseline at Month 6 in mTSS
Timepoint [2] 0 0
Month 6
Primary outcome [3] 0 0
Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6
Timepoint [3] 0 0
Month 6
Primary outcome [4] 0 0
Absolute Blood Pressure (BP) Values (mmHg)
Timepoint [4] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Primary outcome [5] 0 0
Change From Baseline in BP Values (mmHg)
Timepoint [5] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Secondary outcome [1] 0 0
mTSS Score at Baseline, Months 12 and 24
Timepoint [1] 0 0
Baseline, Months 12 and 24
Secondary outcome [2] 0 0
Change From Baseline in mTSS Score at Months 12 and 24
Timepoint [2] 0 0
Months 12 and 24
Secondary outcome [3] 0 0
Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24
Timepoint [3] 0 0
Months 6, 12, and 24
Secondary outcome [4] 0 0
Percentage of Participants With no Worsening in Erosion Score (Increase =0.5) at Months 6, 12, and 24
Timepoint [4] 0 0
Months 6, 12, and 24
Secondary outcome [5] 0 0
Erosion Scores
Timepoint [5] 0 0
Baseline, Months 6, 12, and 24
Secondary outcome [6] 0 0
JSN Scores
Timepoint [6] 0 0
Baseline, Months 6, 12, and 24
Secondary outcome [7] 0 0
Change From Baseline in Erosion Scores
Timepoint [7] 0 0
Months 6, 12, and 24
Secondary outcome [8] 0 0
Change From Baseline in JSN Scores
Timepoint [8] 0 0
Months 6, 12, and 24
Secondary outcome [9] 0 0
Percentage of Participants Achieving an ACR70 Response
Timepoint [9] 0 0
Months 1, 2, 3, 9, 12, 15, 18, 21, and 24
Secondary outcome [10] 0 0
Percentage of Participants Achieving an ACR20 Response
Timepoint [10] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [11] 0 0
Percentage of Participants Achieving an ACR50 Response
Timepoint [11] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [12] 0 0
Tender Joints Count (TJC)
Timepoint [12] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [13] 0 0
Change From Baseline in TJC
Timepoint [13] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [14] 0 0
Swollen Joints Count (SJC)
Timepoint [14] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [15] 0 0
Change From Baseline in SJC
Timepoint [15] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [16] 0 0
Patient Assessment of Arthritis Pain
Timepoint [16] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [17] 0 0
Change From Baseline in Patient Assessment of Arthritis Pain
Timepoint [17] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [18] 0 0
Physician Global Assessment of Arthritis
Timepoint [18] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [19] 0 0
Change From Baseline in Physician Global Assessment of Arthritis
Timepoint [19] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [20] 0 0
Patient Global Assessment of Arthritis
Timepoint [20] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [21] 0 0
Change From Baseline in Patient Global Assessment of Arthritis
Timepoint [21] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [22] 0 0
C-Reactive Protein
Timepoint [22] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [23] 0 0
Change From Baseline in CRP
Timepoint [23] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [24] 0 0
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP
Timepoint [24] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [25] 0 0
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Timepoint [25] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [26] 0 0
Change From Baseline in DAS28-3(CRP)
Timepoint [26] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [27] 0 0
Change From Baseline in DAS28-4(ESR)
Timepoint [27] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [28] 0 0
Percentage of Participants With DAS28-3(CRP) =3.2
Timepoint [28] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [29] 0 0
Percentage of Participants With DAS28-4(ESR) =3.2
Timepoint [29] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [30] 0 0
Percentage of Participants With DAS28-3(CRP) <2.6
Timepoint [30] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [31] 0 0
Percentage of Participants With DAS28-4(ESR) <2.6
Timepoint [31] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [32] 0 0
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement)
Timepoint [32] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [33] 0 0
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement)
Timepoint [33] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [34] 0 0
Percentage of Participants With an ACR70 Response Sustained at Least 6 Months
Timepoint [34] 0 0
Months 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [35] 0 0
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits
Timepoint [35] 0 0
Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [36] 0 0
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits
Timepoint [36] 0 0
Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [37] 0 0
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits
Timepoint [37] 0 0
Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [38] 0 0
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits
Timepoint [38] 0 0
Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [39] 0 0
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits
Timepoint [39] 0 0
Months 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [40] 0 0
Health Assessment Questionnaire Disability Index (HAQ-DI)
Timepoint [40] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [41] 0 0
Change From Baseline in HAQ-DI Score
Timepoint [41] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [42] 0 0
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score
Timepoint [42] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [43] 0 0
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score
Timepoint [43] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [44] 0 0
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI
Timepoint [44] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [45] 0 0
Short Form 36 (SF-36) Mental Component Score
Timepoint [45] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [46] 0 0
SF-36 Physical Component Score
Timepoint [46] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [47] 0 0
Change From Baseline in SF-36 Mental Component Score
Timepoint [47] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [48] 0 0
Change From Baseline in SF-36 Physical Component Score
Timepoint [48] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [49] 0 0
SF-36 Domain Scores
Timepoint [49] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [50] 0 0
Change From Baseline in SF-36 Domain Scores
Timepoint [50] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [51] 0 0
Work Limitation Questionnaire (WLQ) Score
Timepoint [51] 0 0
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [52] 0 0
Change From Baseline in WLQ Scores
Timepoint [52] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [53] 0 0
WLQ Work Loss Index Score
Timepoint [53] 0 0
Baseline and Months 3, 6, and 12
Secondary outcome [54] 0 0
Change From Baseline in WLQ Work Loss Index Score
Timepoint [54] 0 0
Months 3, 6, 12, 15, 18, 21, and 24
Secondary outcome [55] 0 0
European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score
Timepoint [55] 0 0
Baseline and Months 3, 6, 12, 18, and 24
Secondary outcome [56] 0 0
Change From Baseline in EQ-5D Health State Profile Utility Score
Timepoint [56] 0 0
Months 3, 6, 12, 18, and 24
Secondary outcome [57] 0 0
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6
Timepoint [57] 0 0
Baseline and Months 3 and 6
Secondary outcome [58] 0 0
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24
Timepoint [58] 0 0
Months 12, 18, and 24
Secondary outcome [59] 0 0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6
Timepoint [59] 0 0
Baseline and Months 3 and 6
Secondary outcome [60] 0 0
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24
Timepoint [60] 0 0
Months 12, 18, and 24
Secondary outcome [61] 0 0
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6
Timepoint [61] 0 0
Baseline and Months 3 and 6
Secondary outcome [62] 0 0
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24
Timepoint [62] 0 0
Months 12, 18, and 24
Secondary outcome [63] 0 0
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6
Timepoint [63] 0 0
Baseline and Months 3 and 6
Secondary outcome [64] 0 0
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24
Timepoint [64] 0 0
Months 12, 18, and 24
Secondary outcome [65] 0 0
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU
Timepoint [65] 0 0
Baseline, Months 3, 6, 12, 18, and 24
Secondary outcome [66] 0 0
Change From Baseline in Work Productivity and HCRU at Months 3 and 6
Timepoint [66] 0 0
Months 3 and 6
Secondary outcome [67] 0 0
Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24
Timepoint [67] 0 0
Months 12, 18, and 24
Secondary outcome [68] 0 0
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6
Timepoint [68] 0 0
Months 3 and 6
Secondary outcome [69] 0 0
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24
Timepoint [69] 0 0
Months 12, 18, and 24
Secondary outcome [70] 0 0
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6
Timepoint [70] 0 0
Months 3 and 6
Secondary outcome [71] 0 0
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24
Timepoint [71] 0 0
Months 12, 18, and 24
Secondary outcome [72] 0 0
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6
Timepoint [72] 0 0
Months 3 and 6
Secondary outcome [73] 0 0
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24
Timepoint [73] 0 0
Months 12, 18, and 24
Secondary outcome [74] 0 0
Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU
Timepoint [74] 0 0
Months 3, 6, 12, 18, and 24
Secondary outcome [75] 0 0
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3
Timepoint [75] 0 0
Baseline and Months 1, 2, and 3
Secondary outcome [76] 0 0
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS
Timepoint [76] 0 0
Months 1, 2, 3, 6, 12, 18, and 24
Secondary outcome [77] 0 0
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24
Timepoint [77] 0 0
Months 6, 12, 18, and 24
Secondary outcome [78] 0 0
Change From Baseline in MOS-SS at Months 1, 2, and 3
Timepoint [78] 0 0
Months 1, 2, and 3
Secondary outcome [79] 0 0
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24
Timepoint [79] 0 0
Months 6, 12, 18, and 24
Secondary outcome [80] 0 0
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
Timepoint [80] 0 0
Baseline and Months 1, 2, 3, 6, 12, 18, and 24
Secondary outcome [81] 0 0
Change From Baseline in FACIT-Fatigue Scale
Timepoint [81] 0 0
Months 1, 2, 3, 6, 12, 18, and 24
Secondary outcome [82] 0 0
Change From Baseline in Heart Rate
Timepoint [82] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcome [83] 0 0
Change From Baseline in Temperature
Timepoint [83] 0 0
Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Eligibility
Key inclusion criteria
* Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.
* Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
* Active disease as defined by both >=6 tender or painful joints on motion and >= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL
Minimum age
18 Years
Maximum age
99 Years
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
* No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy

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
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
956
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Rheumatology Research Unit Sunshine Coast - Maroochydore
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital, Department of Rheumatology - Woodville
Recruitment hospital [3] 0 0
Emeritus Research - 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
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
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
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
United States of America
State/province [19] 0 0
West Virginia
Country [20] 0 0
Argentina
State/province [20] 0 0
Buenos Aires
Country [21] 0 0
Belgium
State/province [21] 0 0
Gent
Country [22] 0 0
Brazil
State/province [22] 0 0
GO
Country [23] 0 0
Brazil
State/province [23] 0 0
PR
Country [24] 0 0
Brazil
State/province [24] 0 0
RS
Country [25] 0 0
Brazil
State/province [25] 0 0
SP
Country [26] 0 0
Brazil
State/province [26] 0 0
Rio de Janeiro
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Plovdiv
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Ruse
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Sofia
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Veliko Tarnovo
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
Manitoba
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Chile
State/province [35] 0 0
IX Region
Country [36] 0 0
Chile
State/province [36] 0 0
RM
Country [37] 0 0
Chile
State/province [37] 0 0
V Region
Country [38] 0 0
Chile
State/province [38] 0 0
Rancagua
Country [39] 0 0
Colombia
State/province [39] 0 0
Atlantico
Country [40] 0 0
Colombia
State/province [40] 0 0
Cundinamarca
Country [41] 0 0
Colombia
State/province [41] 0 0
Santander
Country [42] 0 0
Costa Rica
State/province [42] 0 0
Cartago
Country [43] 0 0
Costa Rica
State/province [43] 0 0
San Jose
Country [44] 0 0
Czechia
State/province [44] 0 0
Brno - Zidenice
Country [45] 0 0
Czechia
State/province [45] 0 0
Brno
Country [46] 0 0
Czechia
State/province [46] 0 0
Hradec Kralove
Country [47] 0 0
Czechia
State/province [47] 0 0
Ostrava-Poruba
Country [48] 0 0
Czechia
State/province [48] 0 0
Praha 2
Country [49] 0 0
Czechia
State/province [49] 0 0
Praha 4
Country [50] 0 0
Dominican Republic
State/province [50] 0 0
Santo Domingo
Country [51] 0 0
Germany
State/province [51] 0 0
Aachen
Country [52] 0 0
Germany
State/province [52] 0 0
Berlin
Country [53] 0 0
Germany
State/province [53] 0 0
Erlangen
Country [54] 0 0
Germany
State/province [54] 0 0
Halle
Country [55] 0 0
Germany
State/province [55] 0 0
Hamburg
Country [56] 0 0
Germany
State/province [56] 0 0
Nuernberg
Country [57] 0 0
Germany
State/province [57] 0 0
Ratingen
Country [58] 0 0
Germany
State/province [58] 0 0
Rheine
Country [59] 0 0
Hungary
State/province [59] 0 0
Balatonfüred
Country [60] 0 0
Hungary
State/province [60] 0 0
Budapest
Country [61] 0 0
Hungary
State/province [61] 0 0
Mezokovesd
Country [62] 0 0
Hungary
State/province [62] 0 0
Szolnok
Country [63] 0 0
India
State/province [63] 0 0
Andhra Pradesh
Country [64] 0 0
India
State/province [64] 0 0
Gujarat
Country [65] 0 0
India
State/province [65] 0 0
Karnataka
Country [66] 0 0
India
State/province [66] 0 0
Maharashtra
Country [67] 0 0
India
State/province [67] 0 0
Ahmedabad
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Seoul
Country [69] 0 0
Malaysia
State/province [69] 0 0
Negeri Sembilan
Country [70] 0 0
Malaysia
State/province [70] 0 0
Selangor Darul Ehsan
Country [71] 0 0
Malaysia
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Vinnitsa

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.
Trial website
https://clinicaltrials.gov/study/NCT01039688
Trial related presentations / publications
Dikranian AH, Gonzalez-Gay MA, Wellborne F, Alvaro-Gracia JM, Takiya L, Stockert L, Paulissen J, Shi H, Tatulych S, Curtis JR. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies. RMD Open. 2022 May;8(1):e002103. doi: 10.1136/rmdopen-2021-002103.
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.
Bykerk VP, Lee EB, van Vollenhoven R, Gruben DC, Fallon L, Woolcott JC, Keystone E. Identification of Distinct Disease Activity Trajectories in Methotrexate-Naive Patients With Rheumatoid Arthritis Receiving Tofacitinib Over Twenty-Four Months. Arthritis Care Res (Hoboken). 2022 Jan;74(1):131-141. doi: 10.1002/acr.24709.
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.
Strand V, Kaine J, Alten R, Wallenstein G, Diehl A, Shi H, Germino R, Murray CW. Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib. Arthritis Res Ther. 2020 Oct 15;22(1):243. doi: 10.1186/s13075-020-02324-7.
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.
Kivitz AJ, Cohen S, Keystone E, van Vollenhoven RF, Haraoui B, Kaine J, Fan H, Connell CA, Bananis E, Takiya L, Fleischmann R. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006. Epub 2018 Jul 19.
Strand V, Kavanaugh A, Kivitz AJ, van der Heijde D, Kwok K, Akylbekova E, Soonasra A, Snyder M, Connell C, Bananis E, Smolen JS. Long-Term Radiographic and Patient-Reported Outcomes in Patients with Rheumatoid Arthritis Treated with Tofacitinib: ORAL Start and ORAL Scan Post-hoc Analyses. Rheumatol Ther. 2018 Dec;5(2):341-353. doi: 10.1007/s40744-018-0113-7. Epub 2018 May 14.
van Vollenhoven RF, Lee EB, Fallon L, Zwillich SH, Wilkinson B, Chapman D, DeMasi R, Keystone E. Tofacitinib in Rheumatoid Arthritis: Lack of Early Change in Disease Activity and the Probability of Achieving Low Disease Activity at Month 6. Arthritis Care Res (Hoboken). 2019 Jan;71(1):71-79. doi: 10.1002/acr.23585.
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.
Fleischmann RM, Huizinga TW, Kavanaugh AF, Wilkinson B, Kwok K, DeMasi R, van Vollenhoven RF. Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis. RMD Open. 2016 Jul 26;2(2):e000262. doi: 10.1136/rmdopen-2016-000262. eCollection 2016.
Fleischmann R, Strand V, Wilkinson B, Kwok K, Bananis E. Relationship between clinical and patient-reported outcomes in a phase 3 trial of tofacitinib or MTX in MTX-naive patients with rheumatoid arthritis. RMD Open. 2016 Apr 26;2(1):e000232. doi: 10.1136/rmdopen-2015-000232. eCollection 2016.
Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.
Lee EB, Fleischmann R, Hall S, Wilkinson B, Bradley JD, Gruben D, Koncz T, Krishnaswami S, Wallenstein GV, Zang C, Zwillich SH, van Vollenhoven RF; ORAL Start Investigators. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med. 2014 Jun 19;370(25):2377-86. doi: 10.1056/NEJMoa1310476.
Public notes

Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Fax 0 0
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Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01039688