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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: Completed Phase 3 study, sponsored by Centocor.
NCT00361335 is a Phase 3 study that has completed, run by Centocor. The registered enrollment target is 643 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
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.
Primary Outcome
An ACR 50 response is defined as a greater than or equal to 50 percentage 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 (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 physical function as mea
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 |
What the finished NCT00361335 record still lists
NCT00361335 is an interventional study that assigns participants to a tested intervention. The registered 643 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 3 interventions - of which Placebo is the first listed.
NCT00361335 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00361335's enrollment target sits among peer trials
643 573rd of 2000 higher than 1,427 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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