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NCT00361335 · ClinicalTrials.gov registry record · Phase 3
A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
A Phase 3 study, sponsored by Centocor.
- Completed
- Registry status
- Phase 3
- Development phase
- 643
- Enrollment target
NCT00361335 is a Phase 3 study that has completed, run by Centocor. The registered enrollment target is 643 participants.
The verdict
NCT00361335, a Phase 3 study, has completed, sponsored by Centocor.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 643 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC) golimumab injections following transition from IV golimumab infusions will also be evaluated.
Interventions
- DRUG Placebo
- DRUG Methotrexate
- DRUG Golimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 643 participants |
| Start Date | 2006-09 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00361335
The ClinicalTrials.gov registry entry for NCT00361335 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 643 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 3 interventions - of which Placebo is the first listed.
NCT00361335 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00361335 about?
NCT00361335 is a clinical study titled "A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy". The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety...
What is the current status of trial NCT00361335?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 643 participants. The study started on 2006-09. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00361335?
The interventions under investigation include: Placebo (DRUG), Methotrexate (DRUG), Golimumab (DRUG).
Who is sponsoring clinical trial NCT00361335?
This trial is sponsored by Centocor, which has 33 total clinical trials registered on ClinicalTrials.gov.
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