Phase 4 N=10 Treatment

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

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT00502853 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Mar 2015

Primary outcome: Primary: Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Synovitis Score — 3.4; 2.3; -1.1; 2.4 units on a scale — p=0.1776

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: rituximab [MabThera/Rituxan] (Drug); Methotrexate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Synovitis Score	3.4; 2.3; -1.1; 2.4; -1.0	0.1776
PRIMARY OMERACT RAMRIS Bone Edema Score	23.2; 23.8; 0.6; 24.0; 0.8	0.8989
PRIMARY OMERACT RAMRIS Erosion Score	7.9; 8.1; 0.2; 9.1; 1.2	0.5911
PRIMARY Early Enhancement Rate (REE)	0.356; 0.489; 0.150; 0.363; -0.012	0.3358
PRIMARY Relative Enhancement (RE) Score	66.978; 57.889; -3.812; 40.075; -34.450	0.7624
SECONDARY Ritchie Articular Index Scores	20.7; 16.9; -3.8; 9.5; -11.2; 11.7	0.1101
SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) Score	1.788; 1.471; -0.316; 0.838; -0.950; 0.888	0.0240 sig
SECONDARY Patient's Global Assessment of Pain	60.6; 49.0; -11.6; 34.7; -29.9; 22.7	0.0074 sig
SECONDARY DAS28 Score	5.735; 5.261; -0.474; 4.307; -1.587; 4.400	0.1396
SECONDARY Erythrocyte Sedimentation Rate (ESR)	72.6; 63.8; -15.6; 48.0; -30.2; 53.4	0.0254 sig
SECONDARY C-Reactive Protein (CRP)	21.630; 23.480; 1.850; 10.929; -10.929; 23.410	0.7376
SECONDARY Anti-Cyclic Citrullinated Peptide (Anti-CCP) Autoantibodies Count	55.230; 44.311; -10.133; 41.925; -12.862; 122.230	0.1312
SECONDARY Rheumatoid Factor (RF) Immunoglobulin M (IgM) Concentrations	570.922; 307.300; -285.138; 241.756; -329.167; 281.230	0.1725
SECONDARY Total Immunoglobulin (Ig) Concentrations	20.258; 17.786; -1.602; 17.296; -2.336; 18.354	0.2938
SECONDARY Hematocrit Concentration (%)	36.110; 37.860; 1.750; 37.512; 1.350; 37.967	0.0934
SECONDARY Percentage of Total B-lymphocytes	24.040; 22.430; -1.610; 30.125; 5.562; 24.133	0.4963
SECONDARY Erosion Score - Right Hand	2.50; 2.19; -0.44	0.5002
SECONDARY Erosion Score - Left Hand	1.90; 1.75; 0.00	1.0000
SECONDARY Joint Space Narrowing - Right Hand	10.40; 10.13; 0.94	0.7002
SECONDARY Joint Space Narrowing - Left Hand	8.45; 9.13; 2.19	0.3132
SECONDARY X-Rays: Right Hand Total Score	12.90; 12.31; 0.50	0.8597
SECONDARY X-Rays: Left Hand Total Score	10.35; 10.88; 2.19	0.3617

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 =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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00502853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.