An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNF Therapy (REPEAT)

MabThera Post Marketing Observational Study in TNF-IR Patients to Assess Efficacy and Safety of REPeated Courses in routinE ClinicAl pracTice

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01196780

Enrollment

1240

Registered

2010-09-08

Start date

2010-02-28

Completion date

2015-10-31

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 MabThera/Rituxan (Rituximab) in patients with active rheumatoid arthritis who have had an inadequate response or are intolerant to anti-TNF therapy. Data will be collected from patients initiated on MabThera/Rituxan therapy according to standard of care in routine clinical practice. For each patient data will be collected for 92 weeks.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients, \>/= 18 years of age * Active Rheumatoid Arthritis * Inadequate response to anti-TNF * Eligible for MabThera/Rituxan therapy according to physician's decision

Exclusion criteria

* According to Summary of Product Characteristics

Design outcomes

Primary

Measure	Time frame
Efficacy: Change in Disease Activity Score - erythrocyte sedimentation rate (DAS28 - ESR)	from baseline to Week 92

Secondary

Measure	Time frame
Safety: Incidence of adverse events	4 years

Countries

Romania

Outcome results