An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

Terminated

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01277328
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational, prospective, open-label, multi-center study will evaluate the effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 11 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-13
• Study First Posted: 2011-01-14
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Adult patients >/=18 years of age
• Patients with rheumatoid arthritis eligible for RoActemra

Exclusion Criteria

• Hypersensitivity to RoActemra
• Active, severe infections

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in Disease Activity Score 28 (DAS28)	11 months

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	11 months
Proportion of patients with a change in Disease Activity Score 28 (DAS28)	5 months
European League Against Rheumatism (EULAR) response rates	20 weeks
Proportion of patients with disease remission	20 weeks
Proportion of patients with low disease activity	20 weeks