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NCT00381810 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

A Phase 3 study, sponsored by Genentech.

Terminated
Registry status
Phase 3
Development phase
31
Enrollment target

NCT00381810: Clinical Trial Phase 3 study, sponsored by Genentech.

NCT00381810 is a Phase 3 study that was terminated before completion, run by Genentech. The registered enrollment target is 31 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00381810, a Phase 3 study, was terminated before completion, sponsored by Genentech.

TERMINATED
Registry status
Phase 3
Development phase
31 participants
Enrollment target

Study Summary

This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. This study is open to participants previously enrolled in Genentech Study U2971g only.

Primary Outcome

A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator.

Interventions

  • DRUG Acetaminophen
  • DRUG Rituximab
  • DRUG Methylprednisolone
  • DRUG Diphenhydramine

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2006-06-22
Est. Completion 2012-02-29
Phase Phase 3
Genentech

332 total trials

Why NCT00381810 stopped before completion

NCT00381810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 4 interventions - of which Acetaminophen is the first listed.

NCT00381810 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00381810 about?

NCT00381810 is a clinical study titled "A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus". This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. This study is open to participants previously enrol...

What is the current status of trial NCT00381810?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2006-06-22. Estimated completion is 2012-02-29.

What interventions are being tested in trial NCT00381810?

The interventions under investigation include: Acetaminophen (DRUG), Rituximab (DRUG), Methylprednisolone (DRUG), Diphenhydramine (DRUG).

Who is sponsoring clinical trial NCT00381810?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00381810's enrollment target sits among peer trials

31 1914th of 2000 higher than 84 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00381810, the US trial registry maintained by the National Library of Medicine. NCT00381810 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.