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NCT00973479 · ClinicalTrials.gov registry record · Phase 3
An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy
A Phase 3 study, sponsored by Centocor.
- Completed
- Registry status
- Phase 3
- Development phase
- 592
- Enrollment target
NCT00973479: Completed Phase 3 study, sponsored by Centocor.
NCT00973479 is a Phase 3 study that has completed, run by Centocor. The registered enrollment target is 592 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00973479, a Phase 3 study, has completed, sponsored by Centocor.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 592 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone.
Primary Outcome
An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 20 percentage improvement in at least 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS), (0 \[no pain\] to 10 \[worst pain\]) b. Participant's global assessment of disease activity by VAS c. Physician's global assessment of disease activity by VAS d. Participant
Interventions
- OTHER Placebo
- DRUG Golimumab
- DRUG methotrexate (MTX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 592 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
What the finished NCT00973479 record still lists
NCT00973479 is an interventional study that assigns participants to a tested intervention. The registered 592 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 (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00973479 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00973479 about?
NCT00973479 is a clinical study titled "An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy". The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone.
What is the current status of trial NCT00973479?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 592 participants. The study started on 2009-09. Estimated completion is 2013-02.
What interventions are being tested in trial NCT00973479?
The interventions under investigation include: Placebo (OTHER), Golimumab (DRUG), methotrexate (MTX) (DRUG).
Who is sponsoring clinical trial NCT00973479?
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 NCT00973479's enrollment target sits among peer trials
592 643rd of 2000 higher than 1,358 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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