An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid Arthritis

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Biological: Tocilizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01741688

ML28206

Details and patient eligibility

About

This observational study evaluates the use and efficacy of intravenous (IV) tocilizumab in routine clinical practice in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment in accordance with the local label were followed for 6 months.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults, >/= 18 years of age
• Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria
• Participants in whom the treating physician has made the decision to commence tocilizumab treatment (in accordance with the local label); this can include participants who have received tocilizumab treatment within 8 weeks prior to the enrollment visit

Exclusion criteria

• Participants who have received tocilizumab more than 8 weeks prior to the enrollment visit
• Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab
• History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Trial design

16 participants in 1 patient group

Tocilizumab

Description:

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Treatment:

Biological: Tocilizumab