An Observational Study of Rituximab in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

Hoffmann-La Roche79 enrolled

Overview

This observational study will assess the efficacy and safety of combination of rituximab (MabThera) and methotrexate in participants with active refractory rheumatoid arthritis (RA) who have failed to respond to a single course of anti-tumor necrosis factor (TNF) therapy in routine clinical practice. Data will be collected from participants for 12 months after the first dose of rituximab or a minimum of 6 months following a rituximab re-treatment course.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Active rheumatoid arthritis * Inadequate response to a single TNF inhibitor * Participants receiving rituximab therapy in accordance with the prescribing information * Signed data release form within 6 weeks (42 days) of initiating rituximab therapy * Women of childbearing potential must use effective form of contraception Exclusion Criteria: * Contra-indication to receive rituximab according to the local labelling * Previous treatment with rituximab * Treatment with any investigational drug within 30 days prior to enrolment

Locations (5)

Unnamed facility

Beirut, Lebanon

Unnamed facility

Beirut, Lebanon

Unnamed facility

Beirut, Lebanon

Unnamed facility

Byblos, Lebanon

Unnamed facility

Tripoli, Lebanon

Outcomes

Primary Outcomes

Disease Activity Score Based on 28-joints Count (DAS28)

Time frame: Up to 5 years

Secondary Outcomes

Reasons for Re-treatment With Rituximab Within 6 Months of the First Treatment

Time frame: Up to 5 years

Disease Activity Score Based on 28-joints Count (DAS28) 6 Months After the Re-treatment With Rituximab

Time frame: 6 Months After the Re-treatment With Rituximab (up to 5 years)

Demographics of Participants Eligible to Receive Rituximab

Time frame: Baseline

Number of Participants With Adverse Events

Time frame: 5 years

Data from ClinicalTrials.gov

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