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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01283399

Enrollment

Registered

2011-01-26

Start date

2010-08-31

Completion date

2014-04-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Number of Participants With Adverse Events	5 years

Countries

Lebanon

Outcome results