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NCT00083759 · ClinicalTrials.gov registry record · Phase 2
Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate
A Phase 2 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 299
- Enrollment target
NCT00083759: Clinical Trial Phase 2 study, sponsored by Biogen.
NCT00083759 is a Phase 2 study that was terminated before completion, run by Biogen. The registered enrollment target is 299 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (125% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00083759, a Phase 2 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 299 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety, tolerability and efficacy of natalizumab in subjects diagnosed with moderate to severe rheumatoid arthritis (RA) receiving concomitant treatment with methotrexate (MTX). It is thought that natalizumab may stop the movement of certain white blood cells, known as lymphocytes, into joint tissue. These cells are thought to cause damage in the joints leading to the symptoms of RA.
Primary Outcome
≥20% reduction from baseline in painful/tender joint count and swollen joint count and ≥20% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)
Interventions
- DRUG placebo
- DRUG natalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2004-05 |
| Phase | Phase 2 |
Why NCT00083759 stopped before completion
NCT00083759 is an interventional study that assigns participants to a tested intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (125% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00083759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00083759 about?
NCT00083759 is a clinical study titled "Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate". The purpose of this study is to determine the safety, tolerability and efficacy of natalizumab in subjects diagnosed with moderate to severe rheumatoid arthritis (RA) receiving concomitant treatment with methotrexate (MTX). It is thought that natalizumab may stop the movement of certain white blood ...
What is the current status of trial NCT00083759?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 299 participants. The study started on 2004-05.
What interventions are being tested in trial NCT00083759?
The interventions under investigation include: placebo (DRUG), natalizumab (DRUG).
Who is sponsoring clinical trial NCT00083759?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00083759's enrollment target sits among peer trials
299 188th of 2000 higher than 1,813 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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