Clinical trial NCT00502853: A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Synovitis Score
timeFrame: Baseline, Week 4, and Week 24
measure: OMERACT RAMRIS Bone Edema Score
timeFrame: Baseline, Weeks 4 and 24
measure: OMERACT RAMRIS Erosion Score
timeFrame: Baseline, Week 4, and Week 24
measure: Early Enhancement Rate (REE)
timeFrame: Baseline, Weeks 4 and 24
measure: Relative Enhancement (RE) Score
timeFrame: Baseline, Weeks 4 and 24
Secondary outcomes:
measure: Ritchie Articular Index Scores
timeFrame: Baseline and Weeks 4, 12, and 24
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
timeFrame: Baseline and Weeks 4, 12, and 24
measure: Patient's Global Assessment of Pain
timeFrame: Baseline and Weeks 4, 12, and 24
measure: DAS28 Score
timeFrame: Baseline and Weeks 4, 12, and 24
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline and Weeks 4, 12, and 24
measure: C-Reactive Protein (CRP)
timeFrame: Baseline and Weeks 4, 12, and 24
measure: Anti-Cyclic Citrullinated Peptide (Anti-CCP) Autoantibodies Count
timeFrame: Baseline and Weeks 4, 12, and 24
measure: Rheumatoid Factor (RF) Immunoglobulin M (IgM) Concentrations
timeFrame: Baseline and Weeks 4, 12, and 24
measure: Total Immunoglobulin (Ig) Concentrations
timeFrame: Baseline and Weeks 4, 12, and 24
measure: Hematocrit Concentration (%)
timeFrame: Baseline and Weeks 4, 12, and 24
measure: Percentage of Total B-lymphocytes
timeFrame: Baseline and Weeks 4, 12, and 24
measure: Erosion Score - Right Hand
timeFrame: Baseline and Week 24
measure: Erosion Score - Left Hand
timeFrame: Baseline and Week 24
measure: Joint Space Narrowing - Right Hand
timeFrame: Baseline and Week 24
measure: Joint Space Narrowing - Left Hand
timeFrame: Baseline and Week 24
measure: X-Rays: Right Hand Total Score
timeFrame: Baseline and Week 24
measure: X-Rays: Left Hand Total Score
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Università Degli Studi Di Genova - Dimi; Reumatologia
state: Liguria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: