Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01077362 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 312
- Enrollment target
NCT01077362: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT01077362 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 312 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01077362, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 312 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis.
Primary Outcome
An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physi
Interventions
- DRUG placebo
- DRUG ustekinumab 90 mg
- DRUG ustekinumab 45 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01077362 record still lists
NCT01077362 is an interventional study that assigns participants to a tested intervention. The registered 312 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 (60% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01077362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01077362 about?
NCT01077362 is a clinical study titled "A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents". The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis.
What is the current status of trial NCT01077362?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 312 participants. The study started on 2010-03. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01077362?
The interventions under investigation include: placebo (DRUG), ustekinumab 90 mg (DRUG), ustekinumab 45 mg (DRUG).
Who is sponsoring clinical trial NCT01077362?
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 NCT01077362's enrollment target sits among peer trials
312 1102nd of 2000 higher than 895 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04984551 · 312 participants · Phase 2
Impact of Project ECHO on Improving the Quality of Palliative Care in Patients With Advanced Cancer and Their Caregivers in Underserved Areas of Kenya, Nigeria, Ghana, South Africa, India, and Ethiopia
- NCT04999904 · 312 participants · NA
A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability
- NCT05220332 · 312 participants · NA
Church-based Intervention to Improve Blood Pressure in African Americans
- NCT05434234 · 312 participants · Phase 1
A Study of YL201 in Patients With Advanced Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia