Anti-CD20 in Systemic Lupus Erythematosus

Part of paid clinical trials in Denver, Colorado.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00036491
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Lupus Erythematosus, Systemic

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Subjects received four weekly infusions of rituximab at a dose of 375 mg/m\^2

Study Details

The purpose of this study is to determine the safety and effectiveness of rituximab (anti-CD20) in treating systemic lupus erythematosus (SLE). White blood cells in the body called B cells give off substances that are active in promoting SLE disease. Researchers have found that anti-CD20 can block production of these substances in another disease. This study explores whether anti-CD20 will also be safe in people with SLE and whether it may be effective in treating SLE.

Key Dates

Start date
Jan 31, 2001
Status verified
Nov 2017
Primary completion
Jan 31, 2006
Completion
Jan 31, 2006

Study Design

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

Arms

  • Experimental: rituximab
    375 mg/m\^2 administered intravenously

Primary Outcome Measure

Serum Autoantibodies [ Time Frame: Baseline, Week 4, Week 12, Week 24, Week 36 and Week 56 ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of ColoradoDenverColorado80045-
University of RochesterRochesterNew York14623-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Denver, CO

By research site
University of Colorado· Denver, COUniversity of Rochester· Rochester, NYUniversity of Pennsylvania· Philadelphia, PA

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