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NCT00265083 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis
A Phase 3 study, sponsored by Centocor.
- Completed
- Registry status
- Phase 3
- Development phase
- 356
- Enrollment target
NCT00265083: Completed Phase 3 study, sponsored by Centocor.
NCT00265083 is a Phase 3 study that has completed, run by Centocor. The registered enrollment target is 356 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00265083, a Phase 3 study, has completed, sponsored by Centocor.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 356 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections (under the skin) of golimumab for the treatment of active ankylosing spondylitis \[AS(arthritis of the spine)\]. Efficacy will be measured by reduction in the signs and symptoms of active AS, including effects on back pain and stiffness, physical function, range of motion in the spine, quality of life, and rate of spine damage or fusion on x-ray.
Primary Outcome
Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 14 in at least 3 of the 4 domains: patient global, total back pain, function or inflammation.
Interventions
- BIOLOGICAL golimumab
- BIOLOGICAL Golimumab (CNTO 148); placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2005-12 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
What the finished NCT00265083 record still lists
NCT00265083 is an interventional study that assigns participants to a tested intervention. The registered 356 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 (54% lower).
The record links to 0 conditions, and to 2 interventions - of which golimumab is the first listed.
NCT00265083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00265083 about?
NCT00265083 is a clinical study titled "A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis". The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections (under the skin) of golimumab for the treatment of active ankylosing spondylitis \[AS(arthritis of the spine)\]. Efficacy will be measured by reduction in the signs and symptoms of active AS, including effect...
What is the current status of trial NCT00265083?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 356 participants. The study started on 2005-12. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00265083?
The interventions under investigation include: golimumab (BIOLOGICAL), Golimumab (CNTO 148); placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT00265083?
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 NCT00265083's enrollment target sits among peer trials
356 1024th of 2000 higher than 976 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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