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 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 Biopharmaceuticals GmbH Taiwan Branch
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/15
Investigators and Locations
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
- 洪偉哲 風濕免疫科
- 張詩欣 風濕免疫科
- Po-Yuan Wu Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Terminated
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
- Chang-Youh Tsai Division of Rheumatology
- Wei-Sheng Chen Division of Rheumatology
- Hsien-Tzung Liao Division of Rheumatology
- 劉德鈴 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
Co-Principal Investigator
- SONG-CHOU HSIEH Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Taiwan National PI
Co-Principal Investigator
- Yao-Fan Fang Division of Rheumatology
- 陳彥輔 Division of Rheumatology
- TianMing Zhan Division of Rheumatology
- Ping-Han Tsai Division of Rheumatology
- Shue-Fen Lo Division of Rheumatology
- Yu-Huei Huang Division of Dermatology
The Actual Total Number of Participants Enrolled
2 Stop recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
≥ 20% improvement in 68-tender joint count;
≥ 20% improvement in 66-swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Physician global assessment of disease activity
Patient global assessment of disease activity
Patient assessment of pain
Health Assessment Questionnaire - Disability Index (HAQ-DI)
High-sensitivity C-reactive protein (hsCRP).
Baseline and Week 12
Inclution Criteria
Participant 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.
Presence of either at Screening:
>= 1 erosion on x-ray as determined by central imaging review or;
high-sensitivity C-reactive protein (hs-CRP) > laboratory defined upper limit of normal (ULN).
Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
Participant 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 (methotrexate (MTX), sulfasalazine (SSZ), leflunomide (LEF), cyclosporine, apremilast, bucillamin or iguratimod), or participant has an intolerance to or contraindication for DMARDs as defined by the investigator.
Participant 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). The following non-biologic DMARDs are allowed: MTX, sulfasalazine, leflunomide, apremilast, hydroxychloroquine (HCQ) , bucillamine or iguratimod, and have been ongoing for >= 12 weeks and at stable dose for >= 4 weeks prior to the Baseline Visit. No other DMARDs are permitted during the study.
i. Participants 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:
>= 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);
>= 4 weeks for all others.
Exclusion Criteria
Current treatment with > 2 non-biologic DMARDs; or use of DMARDs other than methotrexate, sulfasalazine, leflunomide, apremilast, hydroxychloroquine, bucillamine, or iguratimod; or use of methotrexate in combination with leflunomide.
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 rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). 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
