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NCT03162796 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 383
- Enrollment target
NCT03162796: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT03162796 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 383 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03162796, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 383 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 | 383 participants |
| Start Date | 2017-08-24 |
| Est. Completion | 2019-11-18 |
| Phase | Phase 3 |
What the finished NCT03162796 record still lists
NCT03162796 is an interventional study that assigns participants to a tested intervention. The registered 383 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03162796 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03162796 about?
NCT03162796 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)". 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 NCT03162796?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 383 participants. The study started on 2017-08-24. Estimated completion is 2019-11-18.
What interventions are being tested in trial NCT03162796?
The interventions under investigation include: Placebo (DRUG), Guselkumab (DRUG).
Who is sponsoring clinical trial NCT03162796?
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 NCT03162796's enrollment target sits among peer trials
383 976th of 2000 higher than 1,023 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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