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NCT00424346 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis
A Phase 2 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 2
- Development phase
- 274
- Enrollment target
NCT00424346: Completed Phase 2 study, sponsored by Novartis.
NCT00424346 is a Phase 2 study that has completed, run by Novartis. The registered enrollment target is 274 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (106% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00424346, a Phase 2 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 274 participants
- Enrollment target
Study Summary
The 12-week core study was designed to evaluate risk-benefit of three subcutaneous dose regimens of ACZ885, added on to stable methotrexate (MTX) therapy (greater than or equal to 7.5 mg/week), compared to placebo in patients with active rheumatoid arthritis (RA). The study investigated the magnitude of effect as well as onset of effect for the different dose regimens. The primary objective of the extension studies was to assess long-term safety and tolerability of canakinumab (ACZ885) in patients with active RA. CACZ885A2201E1 evaluated this objective in patients who had participated in the core study (CACZ885A2201) and CACZ885A2201E2 did the same in patients who completed the first extension study.
Primary Outcome
Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: * Patient's pain assessment (assessed using a 100 mm Visual Analog Scale \[VAS\]); * Patient's global assessment of disease activity (VAS 100 mm); * Physician's global assessment of disease activity (VAS 100 mm); * Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score); * Acute
Interventions
- DRUG Placebo
- DRUG Canakinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT00424346 record still lists
NCT00424346 is an interventional study that assigns participants to a tested intervention. The registered 274 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 (106% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00424346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00424346 about?
NCT00424346 is a clinical study titled "Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis". The 12-week core study was designed to evaluate risk-benefit of three subcutaneous dose regimens of ACZ885, added on to stable methotrexate (MTX) therapy (greater than or equal to 7.5 mg/week), compared to placebo in patients with active rheumatoid arthritis (RA). The study investigated the magnitud...
What is the current status of trial NCT00424346?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 274 participants. The study started on 2006-11. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00424346?
The interventions under investigation include: Placebo (DRUG), Canakinumab (DRUG).
Who is sponsoring clinical trial NCT00424346?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00424346's enrollment target sits among peer trials
274 203rd of 2000 higher than 1,797 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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