A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis

• Conditions: Rheumatoid Arthritis; MedDRA version: 8.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

• Registration Number: EUCTR2007-001665-15-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

Patients (male and non-pregnant, non-lactating females) who completed the core CACZ885A2204, CACZ885A2206, or CACZ885A2207 study without serious or severe drug-related adverse effects may enter the extension study upon signing informed consent. A patient is defined as completing the study if he/she completed the core CACZ885A2204 study up to and including visit 18 (Week 30), or the core CACZ885A2206 study up to and including visit 7 (Day 43 / Week 6), or the core CACZ885A2207 study up to and including visit 7 (Day 85 / Week 12).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients for whom continued treatment in the extension is not considered appropriate by the treating physician. Patients who were non-compliant or who demonstrated a major protocol violation in the core study. Patients who did not complete / discontinued from the core study. Patients with drug related serious adverse events or severe adverse events.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified