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

Phase 2

Withdrawn

• Conditions: rheuma; 10003816; joint pain

• Registration Number: NL-OMON31801
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 18

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).

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
• Study Design: Not specified