Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Tocilizumab

• Registration Number: NCT02721004
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This is an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid arthritis participants receiving tocilizumab as per the product label.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-28
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 592

Inclusion Criteria

• Participants with rheumatoid arthritis receiving tocilizumab as per product label

Exclusion Criteria

• No specific exclusion criteria were specified for this non-interventional trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid arthritis participants	Tocilizumab	Rheumatoid arthritis participants receiving tocilizumab intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study.

Primary Outcome Measures

Name	Time	Method
Swollen Joint Count (SJC)	Month 12
Percentage of Participants Achieving American College of Rheumatology (ACR) Response	Month 12
Simplified Disease Activity Index (SDAI) Score	Month 12
Clinical Disease Activity Index (CDAI) Score	Month 12
Tender Joint Count (TJC)	Month 12
Disease Activity Score Based on 28-joints Count (DAS28)	Month 12

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with any Adverse Event (AE)	Up to 36 months