An Observational Quality of Life Study in Participants With Rheumatoid Arthritis Treated With Rituximab

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02507752

ML22064

Details and patient eligibility

About

This multicenter prospective observational study will evaluate the quality of life in participants with rheumatoid arthritis (RA) who are initiated with rituximab (MabThera/Rituxan). Participants will be followed for 6 months from initiation of treatment.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants of both genders who are 18 years or older
• Diagnosis of RA for at least 6 months according to the criteria of the American College of Rheumatology (ACR) of 1987 for the RA classification
• Participants with medically prescribed or being administered with unique rituximab infusion in the least 3 days, according to the approved label
• Ability to meet the program's requirements and to voluntarily sign the Informed Consent Term.

Exclusion criteria

• Participants who have received any investigational medication within less than or equal to (<=) 1 year before the first dose of the currently indicated treatment
• Participants with an active infection
• Participants with conditions that may interfere in the ability to understand the requests of data collection and to obey to the study's requirements
• Functional Class IV defined based on the ACR functionality criteria for RA
• Participants who can not or who do not want, for any reason, to answer the questionnaires.

Trial design

94 participants in 1 patient group

Rituximab

Description:

Participants who are receiving 1000 milligrams (mg) intravenous (IV) infusion of rituximab on Day 1 and Day 15 as part of standard of care of the treating site will be included in this observational study.