Overview

A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
Summary
This multi-center observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Criteria
Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria

- Patient in whom the treating physician has made the decision to commence
RoActemra/Actemra treatment in accordance with the local label (DMARD-IR, TNF-IR or
need of RoActemra/Actemra monotherapy); this can include patients who have received
RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit

Exclusion Criteria:

- Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment
visit

- Patients who have previously received RoActemra/Actemra in a clinical trial or for
compassionate use

- Patients who have received treatment with an investigational agent within 4 weeks (or
5 half-lives of the investigational agent, whichever is longer) before starting
treatment with RoActemra/Actemra

- Patients with a history of autoimmune disease or any joint inflammatory disease other
than rheumatoid arthritis