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NCT03158285 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 741
- Enrollment target
NCT03158285: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT03158285 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 741 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03158285, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 741 participants
- Enrollment target
Study Summary
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.
Primary Outcome
ACR 20 response: \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=ex
Interventions
- DRUG Placebo
- DRUG Guselkumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 741 participants |
| Start Date | 2017-07-12 |
| Est. Completion | 2020-11-10 |
| Phase | Phase 3 |
What the finished NCT03158285 record still lists
NCT03158285 is an interventional study that assigns participants to a tested intervention. The registered 741 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03158285 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03158285 about?
NCT03158285 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis". 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.
What is the current status of trial NCT03158285?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 741 participants. The study started on 2017-07-12. Estimated completion is 2020-11-10.
What interventions are being tested in trial NCT03158285?
The interventions under investigation include: Placebo (DRUG), Guselkumab (DRUG).
Who is sponsoring clinical trial NCT03158285?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03158285's enrollment target sits among peer trials
741 476th of 2000 higher than 1,524 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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