Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tocilizumab; Drug: Methotrexate

Study type: Observational

Funder types: Industry

Identifiers

NCT02608112

ML29256

Details and patient eligibility

About

This multicenter, prospective, non-interventional study is designed to obtain an accurate estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).

Enrollment: 291 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants at least 18 years old
• Participants with moderate to severe RA not previously treated with TCZ (Intravenous [IV] or SC) for whom the rheumatologists have decided to initiate TCZ SC treatment as monotherapy or in combination with another conventional synthetic disease modifying anti-rheumatic drugs (csDMARD)

Exclusion criteria

• Participants taking part in a clinical trial on RA at the time of inclusion
• Participants with a contra-indication to TCZ SC therapy

Trial design

291 participants in 1 patient group

Participants with Moderate to Severe RA

Description:

Participants with moderate or severe RA, naïve to TCZ treatment (IV or SC), and who have no contra-indication to TCZ SC therapy as per the local label are included.

Treatment:

Drug: Methotrexate

Drug: Tocilizumab