EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Biological: Tocilizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02648035

ML29855

Details and patient eligibility

About

The purpose of this study is to evaluate the percentage of participants treated with subcutaneous (SC) Tocilizumab who are still on treatment after 52 weeks and the factors that play a major role in continuation of treatment.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged >/= 18 years of age with rheumatoid arthritis (RA) for whom the treating physician has made the decision to start subcutaneous (SC) Tocilizumab (TCZ) treatment according to approved label within 4 weeks prior to enrolment.

Exclusion criteria

• Participants who have been receiving Tocilizumab (TCZ) for more than 4 weeks prior to enrolment.
• Participants who have received TCZ in past treatments.
• Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) of starting treatment TCZ SC.
• Participants with a history of autoimmune disease or of any joint inflammatory disease other than rheumatoid arthritis (RA).

Trial design

200 participants in 1 patient group

Subcutaneous Tocilizumab

Description:

Participants receiving treatment for rheumatoid arthritis (RA) with subcutaneous Tocilizumab alone or in combination with conventional disease-modifying antirheumatic drugs (DMARDs) according to approved label.

Treatment:

Biological: Tocilizumab