A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Methotrexate; Drug: rituximab [MabThera/Rituxan]

• Registration Number: NCT00576433
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-19
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• adult patients, 18-80 years of age;
• moderate to severe active rheumatoid arthritis;
• inadequate response to previous or current treatment with 1 anti-TNF agent;
• receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for >=4 weeks.

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Exclusion Criteria

• previous treatment with MabThera;
• use of an anti-TNF alpha agent within 8 weeks of study start;
• concurrent treatment with any DMARD other than methotrexate;
• active infection, or history of serious recurrent or chronic infection.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	rituximab [MabThera/Rituxan]	-
1	Methotrexate	-

Primary Outcome Measures

Name	Time	Method
AEs, including infusion-related adverse events	For 48 weeks after initial treatment

Secondary Outcome Measures

Name	Time	Method
Laboratory parameters, vital signs.	Throughout study
ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT.	For 48 weeks after initial treatment.
Safety of re-treatment (AEs)	For 24 weeks after re-treatment.