A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tocilizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01664104

ML28336

Details and patient eligibility

About

This observational, multi-center study will evaluate the treatment regimen, treatment responses and safety of tocilizumab therapy in a routine clinical practice in participants with moderate to severe rheumatoid arthritis (RA). Data will be collected for 6 months with a maximum study duration of 18 months.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of moderate to severe RA according to revised American College of Rheumatology criteria
• Participants have started tocilizumab treatment according to routine clinical practice within 3 months prior to site opening and still in treatment, as well as participants who began treatment at enrollment

Exclusion criteria

• Participants who have started tocilizumab treatment more than 3 months prior to site opening
• Participants who have previously received tocilizumab in a clinical trial setting or for compassionate use
• Participants who have been enrolled in an ongoing clinical trial and/or have received treatment with any investigational drug within 4 weeks prior to study start
• Participants with a history of autoimmune disease or joint inflammatory disease other than RA

Trial design

151 participants in 1 patient group

RA Participants

Description:

Participants with moderate or severe RA who are under tocilizumab treatment in routine clinical practice (in accordance with the local label) will be observed for 6 months from the start of treatment.

Treatment:

Drug: Tocilizumab