An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Etanercept; Drug: Infliximab; Drug: Rituximab; Drug: Adalimumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01592292

ML27923

Details and patient eligibility

About

This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy. Participants have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be collected for 12 months.

Enrollment: 90 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants, >/=20 years of age
• Participants with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative anti-TNF alpha therapy

Exclusion criteria

• Participants whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis
• Participants who have not signed the informed consent form

Trial design

90 participants in 2 patient groups

Rituximab

Description:

Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.

Treatment:

Drug: Rituximab

Other anti-TNF agent

Description:

Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent, including adalimumab, etanercept and infliximab, as per physician's discretion for RA treatment were observed for 12 months.

Treatment:

Drug: Adalimumab

Drug: Infliximab

Drug: Etanercept