At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Rituximabdrug
Likely dose
Rituximab 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, One Arm, Phase I Safety Study of Anti-CD20 Antibody (Rituximab, Rituxan) Therapy in the Treatment of Primary Sjogren's Syndrome
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 14, 2005·Updated Oct 20, 2017
In Brief
A Phase 1 clinical trial evaluating Rituximab for Sjogren's Syndrome. Completed, enrolled 12 participants across 2 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSjogren's Syndrome
CountriesUnited States
CollaboratorsAutoimmunity Centers of Excellence
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2004
First PostedJan 2005
Primary CompletionAug 2006
Study CompletionAug 2009
TodayJul 2026
First PostedJan 14, 2005
Enrollment StartApr 1, 2004
Primary CompletionAug 1, 2006
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 21.5 years ago
Interventions
Rituximabdrug
1000 mg intravenous infusion