A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Janssen Research & Development, LLC
- Study ID
- NCT03158285
- Phase
- PHASE3
- Status
- Completed
Conditions
- Arthritis, Psoriatic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Guselkumab — DRUGParticipants will receive 100 mg of guselkumab as a sterile liquid for SC injection.
- Placebo — DRUGParticipants will receive matching placebo as SC injection.
Study Details
The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Key Dates
- Start date
- Jul 12, 2017
- Status verified
- May 2026
- Primary completion
- Feb 25, 2019
- Completion
- Nov 10, 2020
Study Design
- Enrollment
- 741 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Group 1: GuselkumabParticipants will receive subcutaneous (SC) guselkumab 100 milligram (mg) once every 4 weeks (q4w) from Week 0 through Week 100.
- Experimental: Group 2: Guselkumab and PlaceboParticipants will receive SC guselkumab 100 mg at Weeks 0 and 4 then once every 8 weeks (q8w) (Weeks 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, and 100) and placebo injections at other visits (Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, and 96) to maintain the blind.
- Experimental: Group 3: Placebo Followed by GuselkumabParticipants will receive SC placebo q4w from Week 0 to Week 20 and will cross over at Week 24 to receive SC guselkumab 100 mg q4w from Week 24 through Week 100.
Primary Outcome Measure
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 [ Time Frame: Week 24 ]
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rheumatology Associates | Birmingham | Alabama | 35205 | - |
| Arizona Arthritis & Rheumatology Associates PC | Glendale | Arizona | 85306 | - |
| Arizona Arthritis & Rheumatology Research, PLLC | Mesa | Arizona | 85210 | - |
| Clinical Research Center of Connecticut | Danbury | Connecticut | 06810 | - |
| Dawes Fretzin Clinical Research Group LLC | Indianapolis | Indiana | 46256-4697 | - |
| University of Michigan | Ann Arbor | Michigan | 48109 | - |
| Arthritis Consultants | St Louis | Missouri | 63141 | - |
| Austin Regional Clinic | Austin | Texas | 78731-3146 | - |
Related coverage on Hipa.ai
- Guselkumab Phase 3 for Psoriatic Arthritis Shows Significant ACR20 ImprovementGuselkumab · Feb 25, 2019 · ClinicalTrials.gov
Find similar trials in Birmingham, AL
By research site
Rheumatology Associates· Birmingham, ALArizona Arthritis & Rheumatology Associates PC· Glendale, AZArizona Arthritis & Rheumatology Research, PLLC· Mesa, AZClinical Research Center of Connecticut· Danbury, CTDawes Fretzin Clinical Research Group LLC· Indianapolis, INUniversity of Michigan· Ann Arbor, MI
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