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NCT00094380 · ClinicalTrials.gov registry record · Phase 1

Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077)

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

Completed
Registry status
Phase 1
Development phase
6
Enrollment target

NCT00094380 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 6 participants.

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The verdict

NCT00094380, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study Summary

The purpose of this study is to examine the safety of a single dose of RG2077 in patients with systemic lupus erythematosus (SLE) who are currently receiving cyclophosphamide. This study will also determine if RG2077 is effective in decreasing disease activity in these patients. Study hypothesis: CTLA4-Ig mediates a T cell costimulatory blockade that effectively induces an antigen-specific nonresponsiveness in T cells.

Interventions

  • DRUG Cyclophosphamide
  • DRUG CTLA4-IgG4m (RG2077)

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2004-09
Est. Completion 2006-01
Phase Phase 1

What the Registry Record Tells You About NCT00094380

The ClinicalTrials.gov registry entry for NCT00094380 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Cyclophosphamide is the first listed.

NCT00094380 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00094380 about?

NCT00094380 is a clinical study titled "Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077)". The purpose of this study is to examine the safety of a single dose of RG2077 in patients with systemic lupus erythematosus (SLE) who are currently receiving cyclophosphamide. This study will also determine if RG2077 is effective in decreasing disease activity in these patients. Study hypothesis: C...

What is the current status of trial NCT00094380?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2004-09. Estimated completion is 2006-01.

What interventions are being tested in trial NCT00094380?

The interventions under investigation include: Cyclophosphamide (DRUG), CTLA4-IgG4m (RG2077) (DRUG).

Who is sponsoring clinical trial NCT00094380?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.