Clinical Trial: Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Long-term, Open-label Extension Study Of Tofacitinib (Cp-690,550) For The Treatment Of Psoriatic Arthritis

Brief Summary:

This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this indication.

This study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study.


Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Month 36 ]
    Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
  • Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: Baseline up to Month 36 ]
    Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of Participants With an American College of Rheumatology 20% (ACR20) Response [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21. Month 24, Month 27, Month 30, Month 33, Month 36 ]
    ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
  • Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36 ]
    ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
  • Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21. Month 24, Month 27, Month 30, Month 33, Month 36 ]
    ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
  • Score on Health Assessment Questionnaire- Disability Index [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33. Month 36 ]
    Score on Health Assessment Questionnaire-Disability Index patient reported outcome
  • Number of participants achieving Psoriatic Arthritis Response Criteria (PsARC) [ Time Frame: Month 1, Month 3, Month 6. Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36 ]
    PsARC is comprised of 4 clinical improvement criteria: 1 unit improvement on Physician Global Assessment: 20% (0-100 scale) improvement on the participant assessments; and 30% reduction in number of tender joints; and 30% reduction in the number of swollen joints. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 scores could worsen
  • Physician's Global Assessment of Psoriasis score [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21. Month 24, Month 27, Month 30, Month 33, Month 36 ]
    PGA Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease).
  • Psoriasis Area and Severity Index 75 (PASI) [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36 ]
    Proportion of subjects achieving at least a 75% reduction in PASI relative to baseline and PASI component scores
  • Dactylitis severity score [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36 ]
    Dactylitis score is based upon digit tenderness for each digit of hands and feet ranges from 0-60.
  • Enthesitis score based upon SPARCC (Spondylitis Research Consortium) and Leeds indices [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36 ]
    Enthesitis score is based upon presence/absence of enthesitis at 16 sites (SPARCC) or 6 sites (Leeds)
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36 ]
    BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS) utilizing a visual analogue scale of 0-10 (0=none and 10=very severe). Answers to six questions measuring are averaged for a final score ranging from 0-10.
  • 36-Item Short-Form Health Survey (SF-36) [ Time Frame: Month 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 ]
    SF-36 is a standardized survey evaluating 8

    Original Secondary Outcome: Same as current

    Information By: Pfizer

    Dates:
    Date Received: October 29, 2013
    Date Started: February 17, 2014
    Date Completion: January 2, 2020
    Last Updated: May 30, 2017
    Last Verified: May 2017