Clinical Trials List
2017-08-15 - 2023-11-30
Phase III
Terminated6
ICD-10L40.53
Psoriatic spondylitis
ICD-10L40
Psoriasis
A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) - SELECT - PsA 1
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Trial Applicant
AbbVie
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 張詩欣 風濕免疫科
- Po-Hao Huang 風濕免疫科
- 洪偉哲 風濕免疫科
- Po-Yuan Wu Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chang-Youh Tsai Division of Rheumatology
- Hsien-Tzung Liao Division of Rheumatology
- 劉德鈴 Division of Rheumatology
- Wei-Sheng Chen Division of Rheumatology
The Actual Total Number of Participants Enrolled
4 Stop recruiting
Audit
CRO
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
Audit
None
Taiwan National PI
Co-Principal Investigator
- Ping-Han Tsai Division of Rheumatology
- 陳彥輔 Division of Rheumatology
- Yu-Huei Huang Division of Dermatology
- TianMing Zhan Division of Rheumatology
- Yao-Fan Fang Division of Rheumatology
- Shue-Fen Lo Division of Rheumatology
The Actual Total Number of Participants Enrolled
2 Stop recruiting
Audit
None
Co-Principal Investigator
- SONG-CHOU HSIEH Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- SONG-CHOU HSIEH Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response [ Time Frame: Week 12 ]
Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).
Inclution Criteria
1. Adult male or female, ≥ 18 years old at Screening.
2. Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and
fulfillment of the Classification Criteria for PsA (CASPAR) criteria.
3. Subject has active disease at Baseline defined as ≥ 3 tender joints (based on 68 joint counts) and
≥ 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits.
4. Presence of either at Screening:
≥ 1 erosion on x-ray as determined by central imaging review or;
hs-CRP > laboratory defined upper limit of normal (ULN).
5. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
6. Subject has had an inadequate response (lack of efficacy after a minimum 12 week duration of
therapy) to previous or current treatment with at least 1 non-biologic DMARD at maximally
tolerated dose or up to dose defined in Inclusion Criterion 7 [(inadequate response to MTX is
defined as ≥ 15 to ≤ 25 mg/week; or ≥ 10 mg/week in subjects who are intolerant of MTX at doses
≥ 12.5 mg/week after complete titration; for Japan inadequate response to MTX is defined as
≥ 7.5 mg/week), SSZ, LEF, apremilast, bucillamine or iguratimod)], or subject has an intolerance to
or contraindication for DMARDs as defined by the investigator.
7. Subject who is on current treatment with concomitant non-biologic DMARDs at study entry must
be on ≤ 2 non-biologic DMARDs (except the combination of MTX and leflunomide) at the
following doses: MTX (≤ 25 mg/week), SSZ (≤ 3000 mg/day), leflunomide (LEF) (≤ 20 mg/day),
apremilast (≤ 60 mg/day), HCQ (≤ 400 mg/day), bucillamine (≤ 300 mg/day) or iguratimod
(≤ 50 mg/day) for ≥ 12 weeks and at stable dose for ≥ 4 weeks prior to the Baseline Visit. No other
DMARDs are permitted during the study.
Subjects who need to discontinue DMARDs prior to the Baseline Visit to comply with this
inclusion criterion must follow the procedure specified below or at least five times the mean
terminal elimination half-life of a drug:
o ≥ 8 weeks for LEF if no elimination procedure was followed, or adhere to an elimination
procedure (i.e., 11 days with cholestyramine, or 30 days washout with activated charcoal
or as per local label);
o ≥ 4 weeks for all others.
Exclusion Criteria
1. Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib,
tofacitinib, baricitinib, and filgotinib).
2. Current treatment with > 2 non-biologic DMARDs or use of DMARDs other than MTX, SSZ, LEF,
apremilast, HCQ, bucillamine or iguratimod or use of MTX in combination with LEF at Baseline.
3. History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of
inflammatory joint disease other than PsA (including, but not limited to gout, overlap connective
tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythermatosus). Prior
history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or
additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of
change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made
incorrectly.
The Estimated Number of Participants
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Taiwan
25 participants
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Global
1640 participants
