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Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors (OPAL BEYOND)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01882439
First received: June 18, 2013
Last updated: November 16, 2014
Last verified: November 2014
  Purpose

To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.


Condition Intervention Phase
Psoriatic Arthritis
Drug: Tofacitinib
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With an American College of Rheumatology 20% (ACR20) Response [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    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).

  • Score on Health Assessment Questionnaire-Disability Index [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Score on Health Assessment Questionnaire-Disability Index patient reported outcome


Secondary Outcome Measures:
  • Number of Participants With an American College of Rheumatology 20% (ACR20) Response [ Time Frame: Week 2, Month 1, Month 2, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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: Week 2, Month 1, Month 2, Month 3, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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: Week 2, Month 1, Month 2, Month 3, Month 4, Month 6 ] [ Designated as safety issue: No ]
    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.

  • ACR response criteria components [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    HAQ-DI, CRP, Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, swollen joint count, tender/painful joint count

  • Number of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) [ Time Frame: Month 1, Month 3, Month 6 ] [ Designated as safety issue: No ]
    PsARC is comprised of 4 clinical improvement criteria: 1 unit (0-5 Likert scale) improvement on the Physician Global Assessment (PGA); 20% (0-100 scale) improvement on the participant assessments; and 30% reduction in the 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 Global Assessment (PGA) of Psoriasis Score [ Time Frame: Month 1, Month 3, Month 6 ] [ Designated as safety issue: No ]
    PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1.

  • Psoriasis Area and Severity Index (PASI) [ Time Frame: Month 1, Month 3, Month 6 ] [ Designated as safety issue: No ]
    PASI score ranges from 0 to 72, with higher scores representing greater severity of psoriasis

  • Dactylitis severity score [ Time Frame: Month 1, Month 3 and Month 6 ] [ Designated as safety issue: No ]
    Dactyltis score based upon digit tenderness for each digit of hands and feet ranges from 0-60

  • Enthesitis score based upon SPARCC (Spondylarthritis Research Consortium) and Leeds indices [ Time Frame: Month 1, Month 3, Month 6 ] [ Designated as safety issue: No ]
    Enthesitis score based upon presence/absence of ethesitis at 16 sites (SPARCC) or 6 sites (Leeds)

  • 36-Item Short-Form Health Survey (SF-36) [ Time Frame: Month 1, Month 3, Month 6 ] [ Designated as safety issue: No ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

  • Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Week X [ Time Frame: Month 1, Month 3, Month 6 ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (

  • Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) [ Time Frame: Month 1, Month 3, Month 6 ] [ Designated as safety issue: No ]
    FACIT-F: participant rated questionnaire to assess fatigue

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Month 1, Month 3, Month 6 ] [ Designated as safety issue: No ]
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.


Estimated Enrollment: 390
Study Start Date: July 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Sequence A
Tofacitinib 5 mg BID for 6 months
Drug: Tofacitinib
tablets, 5 mg BID x 6 months
Experimental: Treatment Sequence B
Tofacitinib 10 mg BID for 6 months
Drug: Tofacitinib
tablets, 10 mg BID x 6 months
Placebo Comparator: Treatment Sequence C
Placebo for 3 months then tofacitinib 5 mg BID for 3 months
Other: Placebo
tablets, to match tofacitinib 5 mg BID x 3 months
Drug: Tofacitinib
tablets, 5 mg BID x 3 months
Placebo Comparator: Treatment Sequence D
Placebo for 3 months then tofacitinib 10 mg BID for 3 months
Other: Placebo
tablets, to match tofacitinib 10 mg BID x 3 months
Drug: Tofacitinib
tablets, 10 mg BID x 3 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints
  • Active plaque psoriasis at screening
  • Inadequate efficacy or lack of toleration to previously administered TNF inhibitor

Exclusion Criteria:

  • Non-plaque forms of psoriasis (with exception of nail psoriasis)
  • History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882439

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 127 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01882439     History of Changes
Other Study ID Numbers: A3921125, 2013-001368-46
Study First Received: June 18, 2013
Last Updated: November 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
psoriatic arthritis
tofacitinib
ACR20
HAQ-DI
TNF inhibitor failure

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
Tofacitinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014