A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available

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

• Registration Number: EUCTR2007-000491-16-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-04
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients who completed the core CACZ885A2201 study may enter the extension study upon signing informed consent. A patient is defined as completing the study if he/she completed the core CACZ885A2201 study up to and including Visit 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 CACZ885A2201 study.

Patients who discontinued from the core CACZ885A2201 study before Visit 12.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the long-term safety and tolerability of ACZ885 in patients with active RA who participated in the core CACZ885A2201 study.;Secondary Objective: To evaluate the efficacy of ACZ885 by assessing the response to treatment according to ACR50, ACR20 and ACR70 criteria, DAS28.<br><br>To assess the effect of ACZ885 on ACR components, including a marker of inflammation (hsCRP).<br><br>To assess the immunogenicity of ACZ885.;Primary end point(s): See Primary Objectives.