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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01976364




Registration number
NCT01976364
Ethics application status
Date submitted
29/10/2013
Date registered
5/11/2013
Date last updated
21/05/2020

Titles & IDs
Public title
Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
Scientific title
A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
Secondary ID [1] 0 0
2011-002169-39
Secondary ID [2] 0 0
A3921092
Universal Trial Number (UTN)
Trial acronym
OPAL BALANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tofacitinib
Treatment: Drugs - Tofacitinib
Treatment: Drugs - Methotrexate
Treatment: Drugs - Placebo Methotrexate

Experimental: Tofacitinib -


Treatment: Drugs: Tofacitinib
Tofacitinib 5 mg tablet twice daily

Treatment: Drugs: Tofacitinib
Tofactinib 10 mg tablet twice daily

Treatment: Drugs: Methotrexate
Methotrexate 7.5-20 mg weekly

Treatment: Drugs: Placebo Methotrexate
Placebo to match active methotrexate orally once a week
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
Primary outcome [2] 0 0
Number of Adverse Events (AEs) by Severity
Timepoint [2] 0 0
Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
Primary outcome [3] 0 0
Number of Participants With Abnormal Clinical Laboratory Values
Timepoint [3] 0 0
Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
Primary outcome [4] 0 0
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values
Timepoint [4] 0 0
Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study)
Primary outcome [5] 0 0
Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
Timepoint [5] 0 0
Sub-study: Baseline (Day 1), Month 6
Primary outcome [6] 0 0
Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6
Timepoint [6] 0 0
Sub-study: Baseline (Day 1), Month 6
Secondary outcome [1] 0 0
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response
Timepoint [1] 0 0
Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary outcome [2] 0 0
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response
Timepoint [2] 0 0
Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary outcome [3] 0 0
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response
Timepoint [3] 0 0
Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary outcome [4] 0 0
Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Timepoint [4] 0 0
Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary outcome [5] 0 0
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
Timepoint [5] 0 0
Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary outcome [6] 0 0
Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Timepoint [6] 0 0
Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary outcome [7] 0 0
Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Timepoint [7] 0 0
Main study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary outcome [8] 0 0
Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Timepoint [8] 0 0
Main study: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary outcome [9] 0 0
Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Timepoint [9] 0 0
Main study: Baseline(Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary outcome [10] 0 0
Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Timepoint [10] 0 0
Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary outcome [11] 0 0
Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Timepoint [11] 0 0
Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary outcome [12] 0 0
Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Timepoint [12] 0 0
Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary outcome [13] 0 0
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Timepoint [13] 0 0
Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary outcome [14] 0 0
Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Timepoint [14] 0 0
Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary outcome [15] 0 0
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30 and 36
Timepoint [15] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [16] 0 0
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36
Timepoint [16] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [17] 0 0
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Timepoint [17] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [18] 0 0
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Timepoint [18] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [19] 0 0
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Timepoint [19] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [20] 0 0
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Timepoint [20] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [21] 0 0
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Timepoint [21] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [22] 0 0
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Timepoint [22] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [23] 0 0
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Timepoint [23] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [24] 0 0
Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Timepoint [24] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [25] 0 0
Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36
Timepoint [25] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30 and 36
Secondary outcome [26] 0 0
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36
Timepoint [26] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [27] 0 0
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36
Timepoint [27] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [28] 0 0
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36
Timepoint [28] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [29] 0 0
Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36
Timepoint [29] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [30] 0 0
Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36
Timepoint [30] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [31] 0 0
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36
Timepoint [31] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [32] 0 0
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36
Timepoint [32] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [33] 0 0
Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36
Timepoint [33] 0 0
Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary outcome [34] 0 0
Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12
Timepoint [34] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12
Secondary outcome [35] 0 0
Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12
Timepoint [35] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12
Secondary outcome [36] 0 0
Sub-study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12
Timepoint [36] 0 0
Months 1, 3, 6, 9 and 12
Secondary outcome [37] 0 0
Sub-study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score >0 ) at Months 1, 3, 6, 9 and 12
Timepoint [37] 0 0
Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [38] 0 0
Sub-study: Percent Change From Baseline in Body Surface Area (BSA) (For Participants With BSA >0%) Psoriasis at Months 1, 3, 6, 9 and 12
Timepoint [38] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [39] 0 0
Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12
Timepoint [39] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [40] 0 0
Sub-study: Percentage of Participants With Absence of Dactylitis (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12
Timepoint [40] 0 0
Sub-study: Months 1, 3, 6, 9 and 12
Secondary outcome [41] 0 0
Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12
Timepoint [41] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [42] 0 0
Sub-study: Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI =0) at Months 1, 3, 6, 9 and 12
Timepoint [42] 0 0
Sub-study: Months 1, 3, 6, 9 and 12
Secondary outcome [43] 0 0
Sub-study: Percentage of Participants With Absence of Enthesitis Assessed Using Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12
Timepoint [43] 0 0
Sub-study: Months 1, 3, 6, 9 and 12
Secondary outcome [44] 0 0
Sub-study: Percentage of Participants With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12
Timepoint [44] 0 0
Sub-study: Months 1, 3, 6, 9 and 12
Secondary outcome [45] 0 0
Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12
Timepoint [45] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [46] 0 0
Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12
Timepoint [46] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [47] 0 0
Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12
Timepoint [47] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [48] 0 0
Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12
Timepoint [48] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [49] 0 0
Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12
Timepoint [49] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [50] 0 0
Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12
Timepoint [50] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [51] 0 0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 3, 6, 9 and 12
Timepoint [51] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [52] 0 0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 3, 6, 9 and 12
Timepoint [52] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [53] 0 0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 3, 6, 9 and 12
Timepoint [53] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [54] 0 0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Physical Domain Score at Months 1, 3, 6, 9 and 12
Timepoint [54] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [55] 0 0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 3, 6, 9 and 12
Timepoint [55] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [56] 0 0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 3, 6, 9 and 12
Timepoint [56] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [57] 0 0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 3, 6, 9 and 12
Timepoint [57] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [58] 0 0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 3, 6, 9 and 12
Timepoint [58] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [59] 0 0
Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Emotional Domain Score at Months 1, 3, 6, 9 and 12
Timepoint [59] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [60] 0 0
Sub Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Health Domain Score at Months 1, 3, 6, 9 and 12
Timepoint [60] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [61] 0 0
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 3, 6, 9 and 12
Timepoint [61] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [62] 0 0
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 3, 6, 9 and 12
Timepoint [62] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [63] 0 0
Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 3, 6, 9 and 12
Timepoint [63] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [64] 0 0
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 3, 6, 9 and 12
Timepoint [64] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [65] 0 0
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 3, 6, 9 and 12
Timepoint [65] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [66] 0 0
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 3, 6, 9 and 12
Timepoint [66] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [67] 0 0
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain
Timepoint [67] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [68] 0 0
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 3, 6, 9 and 12
Timepoint [68] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary outcome [69] 0 0
Sub Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 3, 6, 9 and 12
Timepoint [69] 0 0
Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

Eligibility
Key inclusion criteria
* Previous participation in qualifying PsA study involving tofacitinib
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/05/2019
Sample size
Target
Accrual to date
Final
686
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment hospital [3] 0 0
Pacific Private Clinic - Southport
Recruitment hospital [4] 0 0
Emeritus Research - Camberwell
Recruitment hospital [5] 0 0
St. Vincent's Hospital (Melbourne) - Fitzroy
Recruitment hospital [6] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Hampshire
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01976364
Trial related presentations / publications
Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2021 Sep;66(9):3214-3215. doi: 10.1007/s10620-020-06638-z.
Nash P, Coates LC, Kivitz AJ, Mease PJ, Gladman DD, Covarrubias-Cobos JA, FitzGerald O, Fleishaker D, Wang C, Wu J, Hsu MA, Menon S, Fallon L, Romero AB, Kanik KS. Safety and Efficacy of Tofacitinib in Patients with Active Psoriatic Arthritis: Interim Analysis of OPAL Balance, an Open-Label, Long-Term Extension Study. Rheumatol Ther. 2020 Sep;7(3):553-580. doi: 10.1007/s40744-020-00209-4. Epub 2020 Jun 6.
Burmester GR, Curtis JR, Yun H, FitzGerald O, Winthrop KL, Azevedo VF, Rigby WFC, Kanik KS, Wang C, Biswas P, Jones T, Palmetto N, Hendrikx T, Menon S, Rojo R. An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data. Drug Saf. 2020 Apr;43(4):379-392. doi: 10.1007/s40264-020-00904-9.
Gladman DD, Charles-Schoeman C, McInnes IB, Veale DJ, Thiers B, Nurmohamed M, Graham D, Wang C, Jones T, Wolk R, DeMasi R. Changes in Lipid Levels and Incidence of Cardiovascular Events Following Tofacitinib Treatment in Patients With Psoriatic Arthritis: A Pooled Analysis Across Phase III and Long-Term Extension Studies. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1387-1395. doi: 10.1002/acr.23930.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01976364