Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

University of Manitoba15 enrolled

Overview

The purpose of this study is to determine how well Rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells. This will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (RA) patients.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

RituximabDRUG

Rituximab 1000 mg Intravenously day 1 and day 15

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with documented rheumatoid arthritis by ACR criteria * Disease duration \< 5 years * May have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single DMARD or in combination * Tender joint count \>= 6, swollen joint count \>= 6, and one must be a knee * Corticosteroids \<= 10 mg per day permitted on stable doses for at least 4 weeks * Patients must consent to 2 arthroscopic synovial biopsy procedures Exclusion Criteria: * History of severe allergic or anaphylactic reactions to monoclonal antibodies * Previous treatment with Rituximab * Previous treatment with Arava * Injected with steroids within 4 weeks of day 1 of study * Treatment with any investigational agent within 4 weeks of day of study * Any severe or significant medical condition or disease or known active infection * Pregnancy or nursing at present

Locations (1)

Arthritis Centre, University of Manitoba

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis

Time frame: Biopsies of inflamed joint at beginning and at week 8 of study

Secondary Outcomes

To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells

Time frame: Collected at beginning of study and week 8

Data from ClinicalTrials.gov

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