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

Documentation of the Efficacy and Safety of RoActemra in the Treatment of Rheumatoid Arthritis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02721004

Enrollment

592

Registered

2016-03-28

Start date

2009-03-31

Completion date

2014-12-31

Last updated

2016-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, RoActemra, Tocilizumab

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.

Interventions

DRUGTocilizumab

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.

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

\- Participants with rheumatoid arthritis receiving tocilizumab as per product label

Exclusion criteria

\- No specific

Design outcomes

Primary

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

Secondary

Measure	Time frame
Percentage of Participants with any Adverse Event (AE)	Up to 36 months

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026