Pilot study to evaluate the effect of Rituximab 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. - ND

ROCHE0 sitesJuly 2, 2007

ConditionsRheumatoid arthritis MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

DrugsMabthera

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid arthritis
Sponsor: ROCHE
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 2, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ROCHE

Eligibility Criteria

Inclusion Criteria

•1\. Patients capable of understanding and signing the informed consent and of respecting the procedures involved in the study
•2\. Patients with rheumatoid arthritis diagnosed for at least 3 months according to the 1987 criteria of the American College of Rheumatology (ACR)
•3\. Patients experiencing inadequate response to MTX at a dose of 12\.5 25 mg/week (p.o. or parenteral) for at least 12 weeks, with the last 4 weeks prior to baseline maintained at a stable dose. A MTX dose of 7\.5 or 10 mg/week is permitted only in case of documented intolerance to higher doses .
•4\. Disease duration \<\= 10 years
•5\. Anti\-CCP and / or RF positive
•6\. Patients with a DAS 28\-CRP \> 3\.2
•7\. At screening: C reactive protein (CRP) \> 0\.6 mg/dL (6 mg/L) or ESR \> 28 mm/h.
•8\. Age: 18\-75 years.
•9\. Evidence of erosive disease and/or clinical synovitis in a signal (MRI) joint (metacarpophalangeal and/or wrist)
•10\. RA duration \> 1 year: at least one erosion evaluated by a radiograph at the X\-ray and evidence of clinical synovitis

Exclusion Criteria

•Exclusion criteria related to rheumatoid arthritis
•1\. Autoimmune rheumatic diseases other than RA. A past or present medical record reporting inflammatory joint diseases other than RA (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or any other systemic autoimmune disease (e.g. SLE, inflammatory intestinal disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or any other concomitant syndrome).General exclusion criteria
•2\. Surgical operations (including synovectomy) on bones/joints (including fusion or joint replacements) in the 12 weeks prior to the baseline visit or, in the case of scheduled surgery, within 48 weeks of randomization.
•3\. Absence of peripheral venous access.
•4\. Women who are pregnant or breast\-feeding.
•5\. Significant heart disease (NYHA class III \- IV) or lung disease, the latter unrelated to the pathology (including obstructive lung disease).
•6\. Evidence of a serious concomitant and uncontrolled disease concerning the nervous system, kidney, liver, endocrine glands or gastrointestinal tract, which, in the doctor's opinion, would preclude the participation of the patient.
•7\. Primary or secondary immunodeficiency (previous or currently active), including a history of HIV infection.
•8\. Active infections of any kind (excluding mycotic infections of the nail bed), or any important episode requiring hospitalisation or intravenous therapy with anti\-infective agents in the 4 weeks prior to baseline or oral anti\-infective agents in the 2 weeks prior to baseline.
•9\. A history of deep tissue infections (e.g. fasciitis, abscesses, osteomyelitis) within 52 weeks of selection.