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

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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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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 finished NCT00094380 record still lists

NCT00094380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

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

NCT00094380 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00094380's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00094380, the US trial registry maintained by the National Library of Medicine. NCT00094380 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.