A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)

Phase 4

Terminated

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

• Registration Number: NCT01117129
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This randomized, double-blind, placebo controlled, parallel group study will assess the efficacy and safety of rituximab \[MabThera/Rituxan\] in patients with severe active rheumatoid arthritis refractory to at least one anti-TNF treatment, using magnetic resonance imaging (MRI) of the hand for efficacy measurement. Patients will be randomized to receive 2 intravenous infusions 14 days apart of either 1000mg MabThera (group A) or placebo (group B). All patients will receive methotrexate 10-25mg weekly. Patients in group A demonstrating clinical response at week 24 may receive further cycles of MabThera, patients in group B without clinical response will also be treated with active MabThera. Anticipated time on study treatment is up to 2 years. Target sample size is \<50 patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-27
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• adult patients, 18-75 years of age
• active rheumatoid arthritis (DAS28-CRP>3.2)
• refractory to one or more anti-TNF
• on stable treatment for RA for >/=4 weeks
• evidence of erosive disease and/or synovitis in wrist and/or knuckles

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Exclusion Criteria

• active systemic or local infection
• previous or current history of any demyelinization process in central nervous system, pancytopenia or aplasic anaemia
• signs of immunodeficiency, HIV infection or tuberculosis
• contraindications to MRI, such as metal devices, claustrophobia, moderate or severe renal insufficiency, or allergy to contrast agent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	rituximab [Mabthera/Rituxan]	-
A	methotrexate	-
B	placebo	-
B	methotrexate	-
B	rituximab [Mabthera/Rituxan]	-

Primary Outcome Measures

Name	Time	Method
Bone erosion score on magnetic resonance imaging (MRI) using the rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS)	6 months

Secondary Outcome Measures

Name	Time	Method
Synovitis score on MRI using RAMRIS	months 6, 12 and 24
Tender or swollen joint count (ACR criteria)	months 12 and 24
Bone edema score on MRI using RAMRIS	months 6, 12 and 24
Bone erosion score on MRI using RAMRIS	months 12 and 24
Disease activity according to DAS28-CRP	months 12 and 24
Health assessment questionnaire (HAQ)	months 12 and 24