Determining the Responses and Impact of Rituximab-instigated Cell Depletion on T Cells in People With SLE

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT01702038
Phase
PHASE2
Status
Withdrawn

Conditions

  • Lupus Erythematosus, Systemic

Eligibility Criteria

Sex
ALL
Age
19 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    1000 mg administered intravenously

Study Details

The purpose of this study is to determine how B cell subsets and autoantibodies are related to disease remission after rituximab treatment in subjects with Systemic Lupus Erythematosus (SLE).

Key Dates

Start date
Sep 30, 2009
Status verified
Oct 2012

Study Design

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

Arms

  • Experimental: Rituximab
    Participants will receive an intravenous infusion of rituximab on Days 0 and 14

Primary Outcome Measure

Ratio of B and T cell subsets among those with and without a long-term response and those with and without baseline anti-RBP antibody [ Time Frame: Day 0 through month 24 ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
University of RochesterRochesterNew York14642-

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