Anti-CD20 Antibody Therapy for Sjogren's Syndrome

Part of paid clinical trials in Durham, North Carolina.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00101829
Phase
PHASE1
Status
Completed

Conditions

  • Sjogren's Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    1000 mg intravenous infusion

Study Details

The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in treating patients with Sjogren's syndrome (SS). Rituximab is a laboratory-made antibody currently used to treat some kinds of lymphoma. Rituximab may also help people with SS, a disease of the immune system. However, the safety of rituximab in SS patients must first be established.

Key Dates

Start date
Apr 30, 2004
Status verified
Oct 2017
Primary completion
Aug 31, 2006
Completion
Aug 31, 2009

Study Design

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

Arms

  • Experimental: Rituximab Treatment
    Participants will receive rituximab at study entry and at Week 2

Primary Outcome Measure

Count of Participants with Rituximab Related Grade 3 or higher AEs [ Time Frame: Throughout study ]

Locations (2)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-
University of PennsylvaniaPhiladelphiaPennsylvania19104-6160-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NCUniversity of Pennsylvania· Philadelphia, PA

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