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NCT01009086 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis
A Phase 3 study of Arthritis, Psoriatic, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 615
- Enrollment target
- 20
- Study locations
NCT01009086: Completed Phase 3 study of Arthritis, Psoriatic, sponsored by Janssen Research & Development.
NCT01009086 is a Phase 3 study of Arthritis, Psoriatic that has completed, run by Janssen Research & Development. The registered enrollment target is 615 participants, above the 538-participant average among 16 other Arthritis, Psoriatic trials with a reported enrollment target (14% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01009086, a Phase 3 study of Arthritis, Psoriatic, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 615 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the effectiveness (improvement of signs and symptoms) and safety of ustekinumab in participants with active 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 centimeters \[cm\]) 4) Participant's ass
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ustekinumab 45 mg
- DRUG Ustekinumab 90 mg
Study Locations (20)
California
- - Encinitas
- - La Jolla
- - San Diego
Massachusetts
- - Boston
- - Fall River
- - Worcester
Oklahoma
- - Norman
- - Tulsa
Colorado
- - Denver
Connecticut
- - Trumbull
Florida
- - Tampa
Illinois
- - Chicago
Indiana
- - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 615 participants |
| Start Date | 2009-12 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
What the finished NCT01009086 record still lists
NCT01009086 is an interventional study that assigns participants to a tested intervention. The registered 615 participants enrollment target is mid-sized for trials with a published cap, above the 538-participant average among 16 other Arthritis, Psoriatic trials with a reported enrollment target (14% higher).
The record links to 1 condition, with Arthritis, Psoriatic appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01009086 names 20 study sites across 15 states, led by California, Massachusetts, Oklahoma.
Frequently Asked Questions
What is clinical trial NCT01009086 about?
NCT01009086 is a clinical study titled "A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis". The purpose of this study is to evaluate the effectiveness (improvement of signs and symptoms) and safety of ustekinumab in participants with active psoriatic arthritis.
What is the current status of trial NCT01009086?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 615 participants. The study started on 2009-12. Estimated completion is 2013-05.
What conditions does trial NCT01009086 study?
This clinical trial studies the following conditions: Arthritis, Psoriatic.
What interventions are being tested in trial NCT01009086?
The interventions under investigation include: Placebo (DRUG), Ustekinumab 45 mg (DRUG), Ustekinumab 90 mg (DRUG).
Who is sponsoring clinical trial NCT01009086?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01009086 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Arthritis, Psoriatic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01009086's enrollment target sits among peer trials
615 5th of 16 higher than 12 of 16 other Arthritis, Psoriatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arthritis, Psoriatic 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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