A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
Part of paid clinical trials in Avondale, Arizona.
- Sponsor
- Janssen Research & Development, LLC
- Study ID
- NCT04929210
- Phase
- PHASE4
- Status
- Active Not Recruiting
Conditions
- Arthritis, Psoriatic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Guselkumab — DRUGGuselkumab will be administered as subcutaneous injection.
- Placebo — DRUGMatching placebo will be administered as subcutaneous injection.
Study Details
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) axial disease by assessing reduction in axial symptoms and inflammation.
Key Dates
- Start date
- Aug 30, 2021
- Status verified
- Jun 2026
- Primary completion
- Aug 4, 2026
- Completion
- Apr 13, 2027
Study Design
- Enrollment
- 411 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Group 1: Guselkumab and PlaceboParticipants will receive guselkumab and matching placebo subcutaneously (SC) to maintain the blind.
- Experimental: Group 2: GuselkumabParticipants will receive guselkumab SC.
- Experimental: Group 3: Placebo followed by GuselkumabParticipants will receive matching placebo and will cross over to receive guselkumab SC.
Primary Outcome Measure
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24 [ Time Frame: Baseline and Week 24 ]
Locations (38)
Find similar trials in Avondale, AZ
By research site
Arizona Arthritis and Rheumatology Research PLLC 1· Avondale, AZArizona Arthritis & Rheumatology Research, PLLC· Chandler, AZArizona Arthritis and Rheumatology Research PLLC· Mesa, AZArizona Arthritis Research, PLC.· Phoenix, AZArizona Arthritis and Rheumatology Associates· Sun City, AZSouthern Arizona VA Healthcare System· Tucson, AZ
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