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NCT00264537 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive
A Phase 3 study, sponsored by Centocor.
- Completed
- Registry status
- Phase 3
- Development phase
- 637
- Enrollment target
NCT00264537: Completed Phase 3 study, sponsored by Centocor.
NCT00264537 is a Phase 3 study that has completed, run by Centocor. The registered enrollment target is 637 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00264537, a Phase 3 study, has completed, sponsored by Centocor.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 637 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects who have not been previously treated with methotrexate.
Primary Outcome
ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physic
Interventions
- DRUG Placebo capsules
- DRUG Placebo injections
- DRUG Methotrexate capsules
- BIOLOGICAL Golimumab 50 mg injections
- BIOLOGICAL Golimumab 100 mg injections
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 637 participants |
| Start Date | 2005-12 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
What the finished NCT00264537 record still lists
NCT00264537 is an interventional study that assigns participants to a tested intervention. The registered 637 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 (17% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo capsules is the first listed.
NCT00264537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00264537 about?
NCT00264537 is a clinical study titled "A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive". The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects who have not been previously treated with methotrexate.
What is the current status of trial NCT00264537?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 637 participants. The study started on 2005-12. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00264537?
The interventions under investigation include: Placebo capsules (DRUG), Placebo injections (DRUG), Methotrexate capsules (DRUG), Golimumab 50 mg injections (BIOLOGICAL), Golimumab 100 mg injections (BIOLOGICAL).
Who is sponsoring clinical trial NCT00264537?
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 NCT00264537's enrollment target sits among peer trials
637 579th of 2000 higher than 1,422 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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