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

Hoffmann-La Roche592 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

592

Conditions

Rheumatoid Arthritis

Interventions

TocilizumabDRUG

Tocilizumab administered as an intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Bludenz, Austria

Outcomes

Primary Outcomes

Disease Activity Score Based on 28-joints Count (DAS28)

Time frame: Month 12

Simplified Disease Activity Index (SDAI) Score

Time frame: Month 12

Clinical Disease Activity Index (CDAI) Score

Time frame: Month 12

Percentage of Participants Achieving American College of Rheumatology (ACR) Response

Time frame: Month 12

Tender Joint Count (TJC)

Time frame: Month 12

Swollen Joint Count (SJC)

Time frame: Month 12

Secondary Outcomes

Percentage of Participants with any Adverse Event (AE)

Time frame: Up to 36 months

Data from ClinicalTrials.gov

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