A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.

NCT ID: NCT00502853

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-25
• Study Completion Date: 2010-07-23

Brief Summary

This single arm study will measure the effect of MabThera in combination with methotrexate on the progression of synovitis, the extent of bone marrow edema, and the number of erosions in the wrist and hand of patients with rheumatoid arthritis, using a new MRI technique. Patients will receive MabThera 1000mg i.v. on days 1 and 15, in combination with a stable dosage of 10-25mg/week methotrexate throughout the duration of the study. Further courses of MabThera will be provided to eligible patients. MRI will be performed 1-2 weeks before treatment initiation, and repeated 1 and 6 months after the first MabThera infusion. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type: DRUG

1000mg iv on days 1 and 15

Methotrexate

Intervention Type: DRUG

10-25mg/week

Interventions

rituximab [MabThera/Rituxan]

1000mg iv on days 1 and 15

Intervention Type: DRUG

Methotrexate

10-25mg/week

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• adult patients, 18-75 years of age;
• rheumatoid arthritis for >=3 months and <=10 years;
• inadequate response to methotrexate (12.5-25mg/week) for >=3 months;
• evidence of erosive disease and/or clinical synovitis in a signal joint.

Exclusion Criteria

• autoimmune rheumatic diseases other than RA;
• surgical operations on bones/joints in 12 weeks prior to baseline visit;
• concomitant treatment with biologic agents;
• previous treatment with more than one biologic agent approved for RA, or with cell-depleting therapies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Università Degli Studi Di Genova - Dimi; Reumatologia

Genoa, Liguria, Italy

Countries

Italy

Other Identifiers

ML21081

Identifier Type: -

Identifier Source: org_study_id