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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 is a Phase 3 study that has completed, run by Centocor. The registered enrollment target is 637 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00264537
The ClinicalTrials.gov registry entry for NCT00264537 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 637 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 5 interventions - of which Placebo capsules is the first listed.
NCT00264537 reports 0 study locations.
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.
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