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NCT01262365 · ClinicalTrials.gov registry record · Phase 3
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus
A Phase 3 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 793
- Enrollment target
NCT01262365: Completed Phase 3 study, sponsored by UCB Pharma.
NCT01262365 is a Phase 3 study that has completed, run by UCB Pharma. The registered enrollment target is 793 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01262365, a Phase 3 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 793 participants
- Enrollment target
Study Summary
The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)
Primary Outcome
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessmen
Interventions
- DRUG Placebo
- DRUG Epratuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 793 participants |
| Start Date | 2010-12 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
What the finished NCT01262365 record still lists
NCT01262365 is an interventional study that assigns participants to a tested intervention. The registered 793 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01262365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01262365 about?
NCT01262365 is a clinical study titled "Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus". The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)
What is the current status of trial NCT01262365?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 793 participants. The study started on 2010-12. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01262365?
The interventions under investigation include: Placebo (DRUG), Epratuzumab (DRUG).
Who is sponsoring clinical trial NCT01262365?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01262365's enrollment target sits among peer trials
793 429th of 2000 higher than 1,572 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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