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NCT01438489 · ClinicalTrials.gov registry record · Phase 2
A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
A Phase 2 study of Systemic Lupus Erythematosus, sponsored by MedImmune.
- Completed
- Registry status
- Phase 2
- Development phase
- 626
- Enrollment target
- 20
- Study locations
NCT01438489: Completed Phase 2 study of Systemic Lupus Erythematosus, sponsored by MedImmune.
NCT01438489 is a Phase 2 study of Systemic Lupus Erythematosus that has completed, run by MedImmune. The registered enrollment target is 626 participants, above the 374-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (67% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01438489, a Phase 2 study of Systemic Lupus Erythematosus, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 626 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.
Primary Outcome
An SRI (4) responder defined as a participant who had 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of greater than or equal to (\>=) 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of \>= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index 'A' organ system score and no m
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Anifrolumab 300 mg
- BIOLOGICAL Anifrolumab 1000 mg
Study Locations (20)
California
- Research Site - La Jolla
- Research Site - La Palma
- Research Site - Long Beach
- Research Site - Los Angeles
- Research Site - Palm Desert
- Research Site - San Leandro
- Research Site - Upland
Florida
- Research Site - Miami
- Research Site - Ocala
- Research Site - Orlando
- Research Site - Palm Harbor
- Research Site - Tampa
Georgia
- Research Site - Atlanta
- Research Site - Decatur
- Research Site - Stockbridge
Alabama
- Research Site - Birmingham
Idaho
- Research Site - Idaho Falls
Illinois
- Research Site - Chicago
Indiana
- Research Site - Indianapolis
New Mexico
- Research Site - Las Cruces
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 626 participants |
| Start Date | 2012-01 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
What the finished NCT01438489 record still lists
NCT01438489 is an interventional study that assigns participants to a tested intervention. The registered 626 participants enrollment target is mid-sized for trials with a published cap, above the 374-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (67% higher).
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01438489 names 20 study sites across 8 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01438489 about?
NCT01438489 is a clinical study titled "A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus". The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.
What is the current status of trial NCT01438489?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 626 participants. The study started on 2012-01. Estimated completion is 2015-04.
What conditions does trial NCT01438489 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT01438489?
The interventions under investigation include: Placebo (OTHER), Anifrolumab 300 mg (BIOLOGICAL), Anifrolumab 1000 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT01438489?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01438489 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01438489's enrollment target sits among peer trials
626 13th of 99 higher than 87 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus 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.
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