An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: rituximab [Mabthera/Rituxan]

• Registration Number: NCT01075477
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational study will assess the execution, efficacy and safety of treatment with MabThera in patients with rheumatoid arthritis. Data from patients receiving MabThera according to local treatment guidelines will be collected for 29 months. Target sample size is 100-200 patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-25
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• adult patients, >/= 18 years of age
• rheumatoid arthritis
• treatment with rituximab

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Exclusion Criteria

• unable/unwilling to give informed consent to data collection

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	rituximab [Mabthera/Rituxan]	-

Primary Outcome Measures

Name	Time	Method
Efficacy: DAS28	29 months

Secondary Outcome Measures

Name	Time	Method
Efficacy: TJC, SJC, ESR, HAQ, CRP, patient's assessment (VAS)	29 months
Safety: serious and non-serious adverse events	29 months