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Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis (OPAL BALANCE)

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:
NCT01976364
First received: October 29, 2013
Last updated: November 20, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Arthritis, Psoriatic
Drug: Tofacitinib
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long Term, Extension Study Of Tofacitinib (Cp-690,550) For The Treatment Of Psoriatic Arthritis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.


Secondary Outcome Measures:
  • 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 ] [ 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: 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 ] [ 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: 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 ] [ 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.

  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ 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 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 ] [ Designated as safety issue: No ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being. 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 (EQ-5D) [ Time Frame: Month 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 ] [ Designated as safety issue: No ]
    EQ5D is a 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; 1 indicates better health state (no problems) and 3 indicates worst health state.

  • Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) [ Time Frame: Month 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 ] [ Designated as safety issue: No ]
    FACIT-F is a participant rated questionnaire to assess fatigue


Estimated Enrollment: 650
Study Start Date: February 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tofacitinib Drug: Tofacitinib
Tofacitinib 5 mg tablet twice daily
Drug: Tofacitinib
Tofactinib 10 mg tablet twice daily

  Eligibility

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

Inclusion Criteria:

  • Previous participation in qualifying PsA study involving tofacitinib

Exclusion Criteria:

  • Time from End of Study visit of qualifying study is >3 months.
  • Pregnant female, breastfeeding female or female of childbearing potential unwilling or unable to use highly effective birth control for duration of study and one ovulatory cycle thereafter.
  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: NCT01976364

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

  Show 104 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: NCT01976364     History of Changes
Other Study ID Numbers: A3921092, 2011-002169-39
Study First Received: October 29, 2013
Last Updated: November 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Psoriatic Arthritis
Tofacitinib
Xeljanz
CP-690550
Jak-inhibitor
oral treatment
psoriasis
OPAL BALANCE
moderate
sever
pruritus
itch
DLQI

Additional relevant MeSH terms:
Arthritis, Psoriatic
Arthritis
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 23, 2014