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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00502853
• Date of registration: 17/07/2007
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.
• Scientific title: Pilot Study to Evaluate the Effect of Mabthera in Combination With MTX in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Magnetic Resonance Imaging (MRI) in the Hand of Patients With Rheumatoid Arthritis.
• Date of first enrolment: October 25, 2007
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00502853
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Italy

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Methotrexate

Drug: rituximab [MabThera/Rituxan]

Primary Outcome(s)

Early Enhancement Rate (REE) [Time Frame: Baseline, Weeks 4 and 24]

Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Synovitis Score [Time Frame: Baseline, Week 4, and Week 24]

OMERACT RAMRIS Bone Edema Score [Time Frame: Baseline, Weeks 4 and 24]

OMERACT RAMRIS Erosion Score [Time Frame: Baseline, Week 4, and Week 24]

Relative Enhancement (RE) Score [Time Frame: Baseline, Weeks 4 and 24]

Secondary Outcome(s)

Patient's Global Assessment of Pain [Time Frame: Baseline and Weeks 4, 12, and 24]

Erythrocyte Sedimentation Rate (ESR) [Time Frame: Baseline and Weeks 4, 12, and 24]

Percentage of Total B-lymphocytes [Time Frame: Baseline and Weeks 4, 12, and 24]

Anti-Cyclic Citrullinated Peptide (Anti-CCP) Autoantibodies Count [Time Frame: Baseline and Weeks 4, 12, and 24]

Erosion Score - Left Hand [Time Frame: Baseline and Week 24]

Hematocrit Concentration (%) [Time Frame: Baseline and Weeks 4, 12, and 24]

Joint Space Narrowing - Right Hand [Time Frame: Baseline and Week 24]

Health Assessment Questionnaire - Disability Index (HAQ-DI) Score [Time Frame: Baseline and Weeks 4, 12, and 24]

X-Rays: Right Hand Total Score [Time Frame: Baseline and Week 24]

C-Reactive Protein (CRP) [Time Frame: Baseline and Weeks 4, 12, and 24]

DAS28 Score [Time Frame: Baseline and Weeks 4, 12, and 24]

Erosion Score - Right Hand [Time Frame: Baseline and Week 24]

Joint Space Narrowing - Left Hand [Time Frame: Baseline and Week 24]

Rheumatoid Factor (RF) Immunoglobulin M (IgM) Concentrations [Time Frame: Baseline and Weeks 4, 12, and 24]

Total Immunoglobulin (Ig) Concentrations [Time Frame: Baseline and Weeks 4, 12, and 24]

X-Rays: Left Hand Total Score [Time Frame: Baseline and Week 24]

Ritchie Articular Index Scores [Time Frame: Baseline and Weeks 4, 12, and 24]

Secondary ID(s)

ML21081

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/03/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00502853