NCT00424346

Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis

A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) With Three Different Dose Regimens in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate Including 76-week and 96-week Extensions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Canakinumab
DRUG	Placebo

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-09-01
• Completion: 2009-10-01
• First posted: 2007-01-19
• Last updated: 2014-02-10
• Results posted: 2013-06-19

Locations

17 sites across 6 countries: United States, Austria, Belgium, Canada, Germany, Spain