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NCT00299546 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)
A Phase 3 study, sponsored by Centocor.
- Completed
- Registry status
- Phase 3
- Development phase
- 461
- Enrollment target
NCT00299546: Completed Phase 3 study, sponsored by Centocor.
NCT00299546 is a Phase 3 study that has completed, run by Centocor. The registered enrollment target is 461 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00299546, a Phase 3 study, has completed, sponsored by Centocor.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 461 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in subjects who have active rheumatoid arthritis and have been treated previously with at least 1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab).
Primary Outcome
ACR 20 response is an improvement of \>= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments ( patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein)
Interventions
- DRUG Placebo
- BIOLOGICAL Golimumab 100 mg
- BIOLOGICAL Golimumab 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 461 participants |
| Start Date | 2006-02 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT00299546 record still lists
NCT00299546 is an interventional study that assigns participants to a tested intervention. The registered 461 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 (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00299546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00299546 about?
NCT00299546 is a clinical study titled "A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)". The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in subjects who have active rheumatoid arthritis and have been treated previously with at least 1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab).
What is the current status of trial NCT00299546?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 461 participants. The study started on 2006-02. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00299546?
The interventions under investigation include: Placebo (DRUG), Golimumab 100 mg (BIOLOGICAL), Golimumab 50 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT00299546?
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 NCT00299546's enrollment target sits among peer trials
461 822nd of 2000 higher than 1,178 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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