Rituximab for the Treatment of Early Rheumatoid Arthritis (RA)

Part of paid clinical trials in Denver, Colorado.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00396812
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2. Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid.

Study Details

Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by joint swelling, pain, stiffness, damage, and ultimately loss of joint function. Scientists estimate that about 1.3 million people (0.6 percent) of the U.S. adult population have RA. Current therapies target the immune system early in the disease process before joint damage occurs, and include drugs such as methotrexate (MTX) and tumor necrosis factor (TNF)-blocking agents. Rituximab is a disease-modifying antirheumatic drug (DMARD) recently approved by the FDA for use in combination with MTX for treatment of moderately to severely active RA in patients who have had an inadequate response to TNF-blocking agents, in an effort to try to slow the course of the disease. This study will examine the effects of rituximab on the immune response and disease activity in participants with early RA who have not been treated with any disease-modifying agent. In addition, the safety and tolerability of rituximab in this population will be examined.

Key Dates

Start date
Nov 30, 2006
Status verified
Feb 2013
Primary completion
Jul 31, 2009
Completion
Jul 31, 2009

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab

Primary Outcome Measure

Change From Baseline in the Disease Activity Score- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 48 [ Time Frame: Baseline (Day 0), Week 48 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Health Sciences CenterDenverColorado80262-

Find similar trials in Denver, CO

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University of Colorado Health Sciences Center· Denver, CO

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