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NCT00264550 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
A Phase 3 study, sponsored by Centocor.
- Completed
- Registry status
- Phase 3
- Development phase
- 444
- Enrollment target
NCT00264550: Completed Phase 3 study, sponsored by Centocor.
NCT00264550 is a Phase 3 study that has completed, run by Centocor. The registered enrollment target is 444 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00264550, a Phase 3 study, has completed, sponsored by Centocor.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 444 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 (MTX), as compared to methotrexate alone in rheumatoid arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.
Primary Outcome
ACR 20 response is defined as a greater than or equal to 20 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 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 o
Interventions
- DRUG Placebo capsules
- DRUG Methotrexate
- DRUG Placebo injection
- DRUG Golimumab 100 mg
- DRUG Golimumab 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Start Date | 2005-12 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT00264550 record still lists
NCT00264550 is an interventional study that assigns participants to a tested intervention. The registered 444 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 (42% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo capsules is the first listed.
NCT00264550 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00264550 about?
NCT00264550 is a clinical study titled "An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy". The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.
What is the current status of trial NCT00264550?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 444 participants. The study started on 2005-12. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00264550?
The interventions under investigation include: Placebo capsules (DRUG), Methotrexate (DRUG), Placebo injection (DRUG), Golimumab 100 mg (DRUG), Golimumab 50 mg (DRUG).
Who is sponsoring clinical trial NCT00264550?
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 NCT00264550's enrollment target sits among peer trials
444 864th of 2000 higher than 1,135 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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