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NCT00265096 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis
A Phase 3 study, sponsored by Centocor.
- Completed
- Registry status
- Phase 3
- Development phase
- 407
- Enrollment target
NCT00265096: Completed Phase 3 study, sponsored by Centocor.
NCT00265096 is a Phase 3 study that has completed, run by Centocor. The registered enrollment target is 407 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00265096, a Phase 3 study, has completed, sponsored by Centocor.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 407 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy (improvement of signs and symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of active psoriatic arthritis (PsA). Efficacy will be measured by reduction in the signs and symptoms of active PsA, including effects on joint pain and swelling, changes on x-ray related to joint damage, psoriasis skin lesions, physical function, and quality of life.
Primary Outcome
ACR 20 response is an improvement of \>= 20% from baseline (baseline measurement is defined as the closest measurement taken prior to or at the time of the initiation of study medication administration) in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale \[VAS\], Health Assessment Questionnaire \[HAQ\] and C-reactive
Interventions
- BIOLOGICAL golimumab
- BIOLOGICAL Placebo; golimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 407 participants |
| Start Date | 2005-12 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
What the finished NCT00265096 record still lists
NCT00265096 is an interventional study that assigns participants to a tested intervention. The registered 407 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 (47% lower).
The record links to 0 conditions, and to 2 interventions - of which golimumab is the first listed.
NCT00265096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00265096 about?
NCT00265096 is a clinical study titled "A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis". The purpose of this study is to evaluate the safety and efficacy (improvement of signs and symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of active psoriatic arthritis (PsA). Efficacy will be measured by reduction in the signs and symptoms of active PsA, includi...
What is the current status of trial NCT00265096?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 407 participants. The study started on 2005-12. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00265096?
The interventions under investigation include: golimumab (BIOLOGICAL), Placebo; golimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00265096?
This trial is sponsored by Centocor, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00265096's enrollment target sits among peer trials
407 913th of 2000 higher than 1,088 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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