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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01976364
First received: October 29, 2013
Last updated: August 11, 2017
Last verified: August 2017
  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.

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.


Condition Intervention Phase
Arthritis, Psoriatic Drug: Tofacitinib Drug: Methotrexate Drug: Placebo Methotrexate Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Masking Description:
The sub-study will be participant, care provider, investigator and outcomes assessor masked.
Primary Purpose: Treatment
Official Title: A Long-term, Open-label 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 ]
    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.


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 ]
    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 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 ]
    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 ]
    FACIT-F is a participant rated questionnaire to assess fatigue


Other Outcome Measures:
  • Exploratory Primary Measure of Sub-study: Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Month 6 ]
    Change in score from the baseline visit in the sub-study of the Health Assessment Questionnaire-Disability Index

  • Exploratory Primary Measure of Sub-study: Change from Baseline in the Psoriatic Arthritis Disease Activity Score [ Time Frame: Month 6 ]
    Change in PASDAS from the baseline visit in the sub-study

  • Exploratory Secondary Measure of Sub-study: HAQ-DI [ Time Frame: Month 1, Month 3, Month 9, Month 12 ]
    Change from baseline HAQ-DI score in the sub-study

  • Exploratory Secondary Measure of Sub-study: PASDAS [ Time Frame: Month 1, Month 3, Month 9, Month 12 ]
    Change from Baseline in PASDAS in the sub-study

  • Exploratory Secondary Measure of Sub-study: Physician's Global Assessment of Psoriasis (PGA-PsO) score [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Follow-up ]
    PGA -PsO ranges from 0 (no psoriasis) to 5 (severe disease).

  • Exploratory Secondary Measure of the Sub-study: Number of subject achieving Psoriatic Arthritis Response Criteria (PsARC) [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12 ]
    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

  • Exploratory Secondary Measure of Sub-study: Body Surface Area (BSA) [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12 ]
    Percent change from baseline of the BAS in the sub-study.

  • Exploratory Secondary Measure of Sub-study: Dactylitis Severity Score [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12 ]
    Change from baseline in the sub-study of the Dactylitis Severity Score. Dactyltis score based upon digit tenderness for each digit of hands and feet ranges from 0-60

  • Exploratory Secondary Measure of Sub-study: Number of subjects with an absence of dactylitis [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12 ]
    Utilizing the Dactylitis Severity Score results, the number of subjects in the sub-study without dactylitis noted.

  • Exploratory Secondary Measure of Sub-study: Leeds Enthesitis Index Score [ Time Frame: Month 1, Month 3, Month 6, Month 12 ]
    Change from baseline in the sub-study of the Leeds Enthesitis Index. Leeds Enthesitis score based upon presence/absence of enthesitis of 6 sites.

  • Exploratory Secondary Measure of Sub-study: Absence of Enthesitis using the Leeds Enthesitis Index [ Time Frame: Month 1, Month 3, Month 6, Month 12 ]
    Utilizing the Leeds Enthesitis Index results, the number of subjects in the sub-study without enthesitis.

  • Exploratory Secondary Measure of Sub-study: Number of subjects achieving a Minimal Disease Activity (MDS) Response [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12 ]
    A psoriatic arthritis subject is defined as meeting MDA when 5 or greater of the 7 criteria are met: 1) tender/painful joint count < or equal to 1; 2) swollen joint count < or equal to 1; 3) BSA < or equal to 3%; 4) Patient Assessment of Arthritis Pain (by visual analog scale[VAS]) < or equal to 15 mm; 5) Patient Global Assessment of Arthritis VAS < or equal to 20 mm; 6) HAQ-DI < or equal to 0.5; 7) Leeds Enthesitis Index < or equal to 1.

  • Exploratory Secondary Measure of Sub-study: Change in ACR components [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12 ]
    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

  • Exploratory Secondary Measure of Sub-study: Change in 36-Item Short-Form Health Survey (SF-36) [ Time Frame: Month 1, Month 3, Month 6, Month 12 ]
    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).

  • Exploratory Secondary Measure in Sub-study: Change in Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) [ Time Frame: Month 1, Month 3, Month 6, Month 12 ]
    FACIT-F is a participant rated questionnaire to assess fatigue

  • Exploratory Secondary Measure in Sub-study: Change in Euro Quality of Life - Health State Profile Utility Score (EQ-5D) [ Time Frame: Month 1, Month 3, Month 6, Month 12 ]
    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.

  • Exploratory Secondary Measure in Sub-study: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline to Month 12 in Sub-study ]
    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.

  • Exploratory Secondary Measure in Sub-study: Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: Baseline to Month 12 in Sub-study ]
    Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.


Enrollment: 686
Actual Study Start Date: February 17, 2014
Estimated Study Completion Date: January 2, 2020
Estimated Primary Completion Date: January 2, 2020 (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
Drug: Methotrexate
Methotrexate 7.5-20 mg weekly
Other Name: Sub-study
Drug: Placebo Methotrexate
Placebo to match active methotrexate orally once a week
Other Name: Sub-study

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Sub-study Inclusion Criteria:

  • Subjects who have completed at least 24 months of treatment with tofacitinib in the extension study
  • Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)

Sub-study Exclusion Criteria:

-Subjects who are receiving methotrexate by a route other than oral

  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

  Show 147 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01976364     History of Changes
Other Study ID Numbers: A3921092
2011-002169-39 ( EudraCT Number )
OPAL BALANCE ( Other Identifier: Alias Study Number )
Study First Received: October 29, 2013
Last Updated: August 11, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Tofacitinib
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 16, 2017