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Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)

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ClinicalTrials.gov Identifier: NCT01164579
Recruitment Status : Completed
First Posted : July 16, 2010
Results First Posted : April 22, 2015
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Tasocitinib plus Methotrexate
Drug: Tofacitinib plus placebo methotrexate
Drug: Placebo tofacitinib plus Methotrexate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tofacitinib (CP-690,550) Plus Methotrexate (MTX) Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Tofacitinib (CP-690,550) Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Methotrexate Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.

Participant Flow:   Overall Study
    Tofacitinib (CP-690,550) Plus Methotrexate (MTX)   Tofacitinib (CP-690,550)   Methotrexate
STARTED   36   36   37 
COMPLETED   28   27   21 
NOT COMPLETED   8   9   16 
Lack of Efficacy                0                0                6 
Lost to Follow-up                1                1                0 
Withdrawal by Subject                2                5                3 
Protocol Violation                0                1                2 
Adverse Event                4                2                5 
Reason not specified                1                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS): all participants who were randomized to study medication and received at least 1 dose of randomized study medication.

Reporting Groups
  Description
Tofacitinib (CP-690,550) Plus MTX Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Tofacitinib (CP-690,550) Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Methotrexate Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
Total Total of all reporting groups

Baseline Measures
   Tofacitinib (CP-690,550) Plus MTX   Tofacitinib (CP-690,550)   Methotrexate   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   36   37   109 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.8  (12.3)   50.8  (12.8)   47.8  (11.6)   48.8  (12.2) 
Gender 
[Units: Participants]
       
Female   31   30   29   90 
Male   5   6   8   19 


  Outcome Measures

1.  Primary:   Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis   [ Time Frame: Month 3 ]

2.  Primary:   Change From Baseline to Month 6 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema   [ Time Frame: Month 6 ]

3.  Secondary:   Change From Baseline to Months 1, 6, and 12 in OMERACT RAMRIS Wrist and MCP Synovitis   [ Time Frame: Months 1, 6, and 12 ]

4.  Secondary:   Change From Baseline to Months 1, 3, and 12 in OMERACT RAMRIS Bone Marrow Edema in Wrist and MCP   [ Time Frame: Months 1, 3, and 12 ]

5.  Secondary:   Change From Baseline to Months 1, 3, 6, and 12 in OMERACT RAMRIS Wrist and MCP Erosions   [ Time Frame: Months 1, 3, 6, and 12 ]

6.  Secondary:   Modified Total Sharp Score (mTSS) at Months 6 and 12   [ Time Frame: Months 6 and 12 ]

7.  Secondary:   Change From Baseline to Months 6 and 12 in mTSS   [ Time Frame: Months 6 and 12 ]

8.  Secondary:   Joint Space Narrowing (JSN) Scores at Months 6 and 12   [ Time Frame: Months 6 and 12 ]

9.  Secondary:   Change From Baseline to Months 6 and 12 in JSN Scores   [ Time Frame: Months 6 and 12 ]

10.  Secondary:   Erosion Scores at Months 6 and 12   [ Time Frame: Months 6 and 12 ]

11.  Secondary:   Change From Baseline to Months 6 and 12 in Erosion Score   [ Time Frame: Months 6 and 12 ]

12.  Secondary:   Percentage of Participants With an American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20) Response   [ Time Frame: Months 1, 2, 3, 6, 9, and 12 ]

13.  Secondary:   Percentage of Participants With an ACR 50% Improvement (ACR50) Response   [ Time Frame: Months 1, 2, 3, 6, 9, and 12 ]

14.  Secondary:   Percentage of Participants With an ACR 70% Improvement (ACR70) Response   [ Time Frame: Months 1, 2, 3, 6, 9, and 12 ]

15.  Secondary:   Disease Activity Score Based on 28-Joint Count and CRP (DAS28-3 [CRP])   [ Time Frame: Baseline and Months 1, 2, 3, 6, 9, and 12 ]

16.  Secondary:   Change From Baseline in DAS28-3 (CRP)   [ Time Frame: Months 1, 2, 3, 6, 9, and 12 ]

17.  Secondary:   Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-4 [ESR])   [ Time Frame: Baseline and Months 1, 2, 3, 6, 9, and 12 ]

18.  Secondary:   Change From Baseline in DAS28-4 (ESR)   [ Time Frame: Months 1, 2, 3, 6, 9, and 12 ]

19.  Secondary:   Percentage of Participants With DAS28-3 (CRP) Response (Good or Moderate Improvement)   [ Time Frame: Months 1, 2, 3, 6, 9, and 12 ]

20.  Secondary:   Percentage of Participants With DAS28-3 (CRP) Score ≤3.2   [ Time Frame: Months 1, 2, 3, 6, 9, and 12 ]

21.  Secondary:   Percentage of Participants With DAS28-3 (CRP) Score <2.6   [ Time Frame: Months 1, 2, 3, 6, 9, and 12 ]

22.  Secondary:   Percentage of Participants With DAS28-4 (ESR) Response (Good or Moderate Improvement)   [ Time Frame: Months 1, 2, 3, 6, 9, and 12 ]

23.  Secondary:   Percentage of Participants With DAS28-4 (ESR) ≤3.2   [ Time Frame: Months 1, 2, 3, 6, 9, and 12 ]

24.  Secondary:   Percentage of Participants With DAS28-4 (ESR) <2.6   [ Time Frame: Months 1, 2, 3, 6, 9, and 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01164579     History of Changes
Other Study ID Numbers: A3921068
2010-020890-18 ( EudraCT Number )
First Submitted: July 15, 2010
First Posted: July 16, 2010
Results First Submitted: November 5, 2014
Results First Posted: April 22, 2015
Last Update Posted: April 22, 2015