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NCT01283139 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
A Phase 2 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 2
- Development phase
- 834
- Enrollment target
NCT01283139: Completed Phase 2 study, sponsored by MedImmune.
NCT01283139 is a Phase 2 study that has completed, run by MedImmune. The registered enrollment target is 834 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (527% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01283139, a Phase 2 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 834 participants
- Enrollment target
Study Summary
To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).
Primary Outcome
SRI (4) responder is defined as: 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points (with increased deoxyribonucleic acid \[DNA\] binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in Br
Interventions
- OTHER Placebo
- BIOLOGICAL Sifalimumab 200 mg
- BIOLOGICAL Sifalimumab 600 mg
- BIOLOGICAL Sifalimumab 1,200 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 834 participants |
| Start Date | 2011-03-31 |
| Est. Completion | 2014-04-17 |
| Phase | Phase 2 |
What the finished NCT01283139 record still lists
NCT01283139 is an interventional study that assigns participants to a tested intervention. The registered 834 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (527% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01283139 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01283139 about?
NCT01283139 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus". To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).
What is the current status of trial NCT01283139?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 834 participants. The study started on 2011-03-31. Estimated completion is 2014-04-17.
What interventions are being tested in trial NCT01283139?
The interventions under investigation include: Placebo (OTHER), Sifalimumab 200 mg (BIOLOGICAL), Sifalimumab 600 mg (BIOLOGICAL), Sifalimumab 1,200 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT01283139?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01283139's enrollment target sits among peer trials
834 36th of 2000 higher than 1,965 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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