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

A Non-interventional Multicenter Study of MabThera® (Rituximab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

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 Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 99999
  • Beirut, Lebanon, 11-236
  • Beirut, Lebanon
  • Jbeil, Lebanon, 1401
  • Tripoli, Lebanon, 371 Tripoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All participants with active refractory RA who were eligible to receive treatment with methotrexate and rituximab in the Investigators' opinion as per the routine clinical practice following inadequate response to a single cycle of anti-TNF therapy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Rituximab + Methotrexate; All participants with active refractory RA who were eligible to receive treatment with methotrexate and rituximab in the Investigators' opinion as per the routine clinical practice following inadequate response to a single cycle of anti-TNF therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease Activity Score Based on 28-joints Count (DAS28)	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events	5 years
Reasons for Re-treatment With Rituximab Within 6 Months of the First Treatment	Up to 5 years
Disease Activity Score Based on 28-joints Count (DAS28) 6 Months After the Re-treatment With Rituximab	6 Months After the Re-treatment With Rituximab (up to 5 years)
Demographics of Participants Eligible to Receive Rituximab	Baseline

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: January 24, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 26, 2011

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ML25270