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NCT00101829 · ClinicalTrials.gov registry record · Phase 1

Anti-CD20 Antibody Therapy for Sjogren's Syndrome

A Phase 1 study of Sjogren's Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
12
Enrollment target
2
Study locations

NCT00101829: Completed Phase 1 study of Sjogren's Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00101829 is a Phase 1 study of Sjogren's Syndrome that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 12 participants, below the 288-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00101829, a Phase 1 study of Sjogren's Syndrome, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target
2
Study locations

Study 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.

Primary Outcome

The study site will grade the severity of adverse events (AEs) experienced by the study participants according to the criteria set forth in the National Cancer Institute's Common Toxicity Criteria for Adverse Events Version 3.0 (published June 10, 2003).

Conditions Studied

Interventions

  • DRUG Rituximab

Study Locations (2)

North Carolina

  • Duke University Medical Center - Durham

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2004-04
Est. Completion 2009-08
Phase Phase 1

What the finished NCT00101829 record still lists

NCT00101829 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 288-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Sjogren's Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Rituximab is the first listed.

NCT00101829 reports a single indexed study location in North Carolina, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00101829 about?

NCT00101829 is a clinical study titled "Anti-CD20 Antibody Therapy for Sjogren's Syndrome". 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. ...

What is the current status of trial NCT00101829?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2004-04. Estimated completion is 2009-08.

What conditions does trial NCT00101829 study?

This clinical trial studies the following conditions: Sjogren's Syndrome.

What interventions are being tested in trial NCT00101829?

The interventions under investigation include: Rituximab (DRUG).

Who is sponsoring clinical trial NCT00101829?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00101829 being conducted?

This trial has 2 study locations across North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Sjogren's Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00101829's enrollment target sits among peer trials

12 21st of 20 the lowest of 20 other Sjogren's Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Sjogren's Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00101829, the US trial registry maintained by the National Library of Medicine. NCT00101829 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.