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NCT01408576 · ClinicalTrials.gov registry record · Phase 3

Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

A Phase 3 study, sponsored by UCB Pharma.

Completed
Registry status
Phase 3
Development phase
1,250
Enrollment target

NCT01408576: Completed Phase 3 study, sponsored by UCB Pharma.

NCT01408576 is a Phase 3 study that has completed, run by UCB Pharma. The registered enrollment target is 1,250 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01408576, a Phase 3 study, has completed, sponsored by UCB Pharma.

COMPLETED
Registry status
Phase 3
Development phase
1,250 participants
Enrollment target

Study Summary

The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

Primary Outcome

A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

Interventions

  • DRUG Epratuzumab

Trial Details

FieldValue
Enrollment Target 1,250 participants
Start Date 2011-07
Est. Completion 2016-02
Phase Phase 3
UCB Pharma

100 total trials

What the finished NCT01408576 record still lists

NCT01408576 is an interventional study that assigns participants to a tested intervention. Its 1,250 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% higher).

The record links to 0 conditions, and to 1 intervention - of which Epratuzumab is the first listed.

NCT01408576 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01408576 about?

NCT01408576 is a clinical study titled "Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus". The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

What is the current status of trial NCT01408576?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,250 participants. The study started on 2011-07. Estimated completion is 2016-02.

What interventions are being tested in trial NCT01408576?

The interventions under investigation include: Epratuzumab (DRUG).

Who is sponsoring clinical trial NCT01408576?

This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01408576's enrollment target sits among peer trials

1,250 207th of 2000 higher than 1,791 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 NCT01408576, the US trial registry maintained by the National Library of Medicine. NCT01408576 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.