An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Biological: Rituximab

Study type: Observational

Funder types: Industry

Identifiers

NCT01613027

ML27998

Details and patient eligibility

About

This observational study will evaluate the effect on disease activity and the safety in routine clinical practice of MabThera (rituximab) in participants with active seropositive rheumatoid arthritis, who have an inadequate response to one or more tumour necrosis factor inhibitor (anti-TNF) therapies.

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years with rheumatoid arthritis (RA)
• Seropositive participants with RA (positive for rheumatoid factor (RF) and/or anti-Citrullinated Cyclic Peptide [CCP])
• Active disease despite receiving one or more TNF inhibitors
• Absence of serious or active infection

Exclusion criteria

• Participants with serious history of heart failure (class New York Heart Association [NYHA] IV) or severe uncontrolled heart disease
• Participants pregnant or lactating
• Prior treatment with Mabthera®
• Participants receiving any other investigational product in the context of other clinical study
• Participants with known hypersensitivity to rituximab or to any of the excipients

Trial design

135 participants in 1 patient group

Rituximab

Description:

Rituximab administered according to prescribing information and normal clinical practice.

Treatment:

Biological: Rituximab