A Study Comparing ABT-494 to Placebo in Subjects with Psoriatic Arthritis Who Have an Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug
- Conditions
- Moderately to Severely Active Psoriatic ArthritisTherapeutic area: Diseases [C] - Immune System Diseases [C20]MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859
- Registration Number
- EUCTR2016-004152-30-GR
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 642
1. Male or female, at least 18 years of age
2. Diagnosed with psoriatic arthritis with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR)
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. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
5. Subject has had an inadequate response or an intolerance to treatment with at least 1 bDMARD
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 518
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 124
1. Prior exposure to any Janus Kinase (JAK) inhibitor
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To compare the efficacy of upadacitinib 15 mg QD and 30 mg QD versus placebo for the treatment of signs and symptoms of subjects with moderately to severely active PsA who have an inadequate response to bDMARDs (Bio-IR).<br>2. To compare the safety and tolerability of upadacitinib 15 mg QD and 30 mg QD versus placebo in subjects with moderately to severely active PsA who have an inadequate response to bDMARDs.;Secondary Objective: To evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in subjects with PsA who have completed Period 1.;Primary end point(s): The proportion of subjects achieving ACR20 response;Timepoint(s) of evaluation of this end point: Week 12<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change from baseline in HAQ-DI <br>2. Proportion of subjects achieving a static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline <br>3. Psoriasis Area Severity Index (PASI) 75 response (for subjects with = 3% BSA psoriasis at baseline)<br>4. Change from baseline in SF-36 PCS <br>5. Change from baseline in FACIT-Fatigue Questionnaire<br>6. Proportion of subjects achieving Minimal Disease Activity (MDA) <br>7. Change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire <br>8. ACR 50/70 response rate <br>9. ACR 20 response rate;Timepoint(s) of evaluation of this end point: 1. Week 12<br>2. Week 16<br>3. Week 16<br>4. Week 12<br>5. Week 12<br>6. Week 24<br>7. Week 16<br>8. Week 12<br>9. Week 2