Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Phase 3 Completed N=686 Treatment

Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

Arthritis, Psoriatic
Source: ClinicalTrials.gov NCT01976364 ↗
Enrolled (actual)
686
Serious AEs
14.1%
Results posted
May 2020
Primary outcomePrimary: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 83.7; 16.8 percentage of participants
◆ Published Evidence
Established
40citations · ~8 / year
Safety and efficacy of tofacitinib up to 48 months in patients with active psoriatic arthritis: final analysis of the OPAL Balance long-term extension study.
The Lancet. Rheumatology · 2021 · Open access · Likely link
Full text ↗ PubMed 38279411 ↗ +4 more ↓

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.

Linked Publications (5)

  • Safety and efficacy of tofacitinib up to 48 months in patients with active psoriatic arthritis: final analysis of the OPAL Balance long-term extension study.
    The Lancet. Rheumatology · 2021 · 40 citations · Open access · Likely link
    Full text ↗PubMed 38279411 ↗
  • Tofacitinib as monotherapy following methotrexate withdrawal in patients with psoriatic arthritis previously treated with open-label tofacitinib plus methotrexate: a randomised, placebo-controlled substudy of OPAL Balance.
    The Lancet. Rheumatology · 2021 · 22 citations · Likely link
    Full text ↗PubMed 38273637 ↗
  • Efficacy and safety of tofacitinib in an open-label, long-term extension study in patients with psoriatic arthritis who received adalimumab or tofacitinib in a Phase 3 randomized controlled study: a post hoc analysis.
    Arthritis research & therapy · 2024 · 2 citations · Open access · Likely link
    Full text ↗PubMed 39702318 ↗
  • Response to Tofacitinib in Patients with Psoriatic Arthritis and Probable Anxiety/Depressive Disorder: A Post Hoc Analysis of Phase 3 Trials.
    Rheumatology and therapy · 2025 · 0 citations · Open access · Likely link
    Full text ↗PubMed 41148555 ↗
  • Long-term tofacitinib efficacy and safety in psoriatic arthritis with or without prior biologic DMARD exposure: a post hoc analysis.
    Rheumatology advances in practice · 2025 · 0 citations · Open access · Likely link
    Full text ↗PubMed 40241921 ↗

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)		 83.7; 16.8 —
PRIMARY
Number of Adverse Events (AEs) by Severity		 1632; 1045; 136 —
PRIMARY
Number of Participants With Abnormal Clinical Laboratory Values		 646 —
PRIMARY
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values		 9 —
PRIMARY
Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6		 0.0174; 0.0428 —
PRIMARY
Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6		 0.138; 0.229 —
SECONDARY
Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response		 66.12; 68.79; 70.66; 71.48; 74.18; 78.04 —
SECONDARY
Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response		 45.70; 43.27; 47.08; 50.41; 50.26; 55.42 —
SECONDARY
Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response		 24.85; 26.13; 30.50; 30.81; 32.13; 33.87 —
SECONDARY
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		 -0.4373; -0.4559; -0.4755; -0.4841; -0.4782; -0.5108 —
SECONDARY
Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)		 68.46; 69.56; 73.14; 74.46; 76.08; 79.52 —
SECONDARY
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		 -1.1; -1.1; -1.2; -1.2; -1.1; -1.2 —
SECONDARY
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		 55.05; 57.96; 60.74; 61.07; 63.16; 65.71 —
SECONDARY
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		 -64.09; -66.98; -68.58; -70.42; -71.58; -73.13 —
SECONDARY
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		 -62.60; -66.92; -68.63; -70.33; -70.81; -72.49 —
SECONDARY
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		 -6.7; -6.8; -7.2; -7.4; -7.6; -7.7 —
SECONDARY
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		 -1.5; -1.6; -1.7; -1.8; -1.7; -2.0 —
SECONDARY
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		 -2.8; -3.0; -3.2; -3.4; -3.5; -3.7 —
SECONDARY
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		 -2.26; -2.10; -2.40; -2.35; -2.41; -2.35 —
SECONDARY
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		 -2.59; -2.41; -2.74; -2.63; -2.65; -2.65 —
SECONDARY
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		 6.44; 6.71; 7.23; 7.44; 7.79; 8.06 —
SECONDARY
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		 4.72; 4.98; 5.25; 5.53; 5.79; 5.82 —
SECONDARY
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		 6.06; 6.44; 7.00; 7.31; 7.69; 7.96 —
SECONDARY
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		 6.19; 6.56; 6.61; 7.07; 7.46; 7.64 —
SECONDARY
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		 8.36; 8.52; 9.29; 9.70; 9.95; 10.21 —
SECONDARY
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		 3.89; 4.09; 4.68; 4.76; 4.89; 4.81 —
SECONDARY
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		 5.92; 6.03; 6.72; 6.67; 7.10; 7.62 —
SECONDARY
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		 6.08; 6.51; 7.16; 6.76; 7.28; 7.64 —
SECONDARY
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		 5.40; 5.39; 5.73; 6.71; 6.82; 6.54 —
SECONDARY
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		 4.85; 5.39; 5.56; 5.82; 6.09; 6.18 —
SECONDARY
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		 -0.24; -0.30; -0.28; -0.30; -0.31; -0.30 —
SECONDARY
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		 -0.19; -0.20; -0.19; -0.21; -0.21; -0.23 —
SECONDARY
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		 -0.27; -0.30; -0.33; -0.32; -0.36; -0.34 —
SECONDARY
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		 -0.31; -0.32; -0.36; -0.40; -0.41; -0.41 —
SECONDARY
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		 -0.23; -0.26; -0.25; -0.26; -0.29; -0.31 —
SECONDARY
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		 14.12; 15.71; 16.00; 16.68; 17.43; 17.87 —
SECONDARY
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		 7.0; 7.7; 7.8; 8.1; 8.3; 8.7 —
SECONDARY
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		 3.1; 3.4; 3.5; 3.6; 3.7; 3.9 —
SECONDARY
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		 3.9; 4.2; 4.4; 4.5; 4.6; 4.8 —
SECONDARY
Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12		 -0.0164; 0.0322; 0.0057; 0.0381; 0.0720; 0.0663 —
SECONDARY
Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12		 0.000; 0.032; 0.188; 0.165; 0.158; 0.371 —
SECONDARY
Sub-study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12		 12.36; 12.22; 11.24; 6.67; 12.36; 6.67 —
SECONDARY
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		 -0.1; 0.2; -0.1; 0.1; -0.1; 0.2 —
SECONDARY
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		 28.47; 9.04; 43.58; 13.47; 41.51; 17.19 —
SECONDARY
Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12		 -0.4; 0.0; -0.3; -1.0; -0.3; -1.0 —
SECONDARY
Sub-study: Percentage of Participants With Absence of Dactylitis (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12		 14.29; 0.0; 14.29; 0.0; 14.29; 0.0 —
SECONDARY
Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12		 -0.2; -0.4; -0.3; -0.5; -0.5; -0.7 —
SECONDARY
Sub-study: Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI =0) at Months 1, 3, 6, 9 and 12		 0.2; 0.1; 0.2; 0.0; 0.2; 0.2 —
SECONDARY
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		 13.33; 25.00; 13.33; 43.75; 26.67; 56.25 —
SECONDARY
Sub-study: Percentage of Participants With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12		 50.56; 55.56; 50.56; 54.44; 46.07; 48.89 —
SECONDARY
Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12		 0.7; 0.3; 1.3; 0.9; 0.5; 0.5 —
SECONDARY
Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12		 -0.1; 0.0; 0.3; 0.3; 0.1; 0.1 —
SECONDARY
Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12		 -0.42; -0.17; 1.98; 2.76; 1.18; 1.65 —
SECONDARY
Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12		 1.35; -0.68; 2.11; 1.68; 3.17; 4.45 —
SECONDARY
Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12		 -0.05; -1.16; 1.59; 0.36; 3.12; 4.07 —
SECONDARY
Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12		 -0.1171; -0.2706; -0.3625; -0.9285; 0.5354; -0.2637 —
SECONDARY
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		 -0.55; -0.22; -0.90; -0.57; -0.65; -1.42 —
SECONDARY
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		 0.35; -0.11; 0.09; -0.77; -0.23; -0.89 —
SECONDARY
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		 -0.37; -0.15; -0.50; -0.33; -0.27; -0.80 —
SECONDARY
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		 -0.27; 0.22; -1.04; 0.21; -1.57; -0.87 —
SECONDARY
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		 -0.77; -0.06; -1.59; -1.24; -0.61; -2.42 —
SECONDARY
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		 0.20; -0.48; 0.34; -0.79; 0.24; -0.57 —
SECONDARY
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		 -0.04; -0.39; -0.26; -1.12; 0.01; -1.70 —
SECONDARY
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		 -0.99; -0.22; -0.80; -1.18; -1.16; -1.74 —
SECONDARY
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		 1.14; -0.53; 0.24; -0.38; -0.72; -0.82 —
SECONDARY
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		 -0.30; 0.63; -0.42; -0.31; -0.01; -0.26 —
SECONDARY
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		 -1.9; -1.1; -1.8; -1.3; -1.3; -2.0 —
SECONDARY
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		 -0.9; -0.5; -0.8; -0.9; -0.5; -1.3 —
SECONDARY
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		 -1.1; -0.6; -1.1; -0.4; -0.8; -0.7 —
SECONDARY
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		 0.0; 0.0; 0.0; 0.0; 0.0; 0.1 —
SECONDARY
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		 0.0; 0.0; 0.0; 0.0; 0.0; 0.0 —
SECONDARY
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		 0.0; 0.0; 0.0; 0.0; 0.0; 0.1 —
SECONDARY
Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain		 0.1; 0.0; 0.1; 0.1; 0.1; 0.1 —
SECONDARY
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		 0.1; 0.0; 0.0; 0.0; 0.1; 0.0 —
SECONDARY
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		 2.0; -0.9; 0.5; -1.1; 4.4; -1.9 —

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01976364) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search