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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 is a Phase 3 study that has completed, run by Centocor. The registered enrollment target is 356 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00265083
The ClinicalTrials.gov registry entry for NCT00265083 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 356 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centocor, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which golimumab is the first listed.
NCT00265083 reports 0 study locations.
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.
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