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NCT01753193 · ClinicalTrials.gov registry record · Phase 2
An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
A Phase 2 study of Lupus Erythematosus, Systemic, sponsored by MedImmune.
- Completed
- Registry status
- Phase 2
- Development phase
- 218
- Enrollment target
- 20
- Study locations
NCT01753193: Completed Phase 2 study of Lupus Erythematosus, Systemic, sponsored by MedImmune.
NCT01753193 is a Phase 2 study of Lupus Erythematosus, Systemic that has completed, run by MedImmune. The registered enrollment target is 218 participants, above the 196-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (11% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01753193, a Phase 2 study of Lupus Erythematosus, Systemic, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 218 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may requ
Conditions Studied
Interventions
- BIOLOGICAL Anifrolumab
Study Locations (20)
California
- Research Site - La Palma
- Research Site - Long Beach
- Research Site - Los Angeles
- Research Site - Palm Desert
- Research Site - Upland
Florida
- Research Site - Ocala
- Research Site - Orlando
- Research Site - Tampa
Georgia
- Research Site - Atlanta
- Research Site - Stockbridge
North Carolina
- Research Site - Charlotte
- Research Site - Raleigh
Alabama
- Research Site - Birmingham
Illinois
- Research Site - Chicago
Indiana
- Research Site - Indianapolis
New Mexico
- Research Site - Las Cruces
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2013-03-28 |
| Est. Completion | 2018-07-18 |
| Phase | Phase 2 |
What the finished NCT01753193 record still lists
NCT01753193 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, above the 196-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (11% higher).
The record links to 1 condition, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 1 intervention - of which Anifrolumab is the first listed.
NCT01753193 names 20 study sites across 12 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01753193 about?
NCT01753193 is a clinical study titled "An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults". The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).
What is the current status of trial NCT01753193?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 218 participants. The study started on 2013-03-28. Estimated completion is 2018-07-18.
What conditions does trial NCT01753193 study?
This clinical trial studies the following conditions: Lupus Erythematosus, Systemic.
What interventions are being tested in trial NCT01753193?
The interventions under investigation include: Anifrolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01753193?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01753193 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01753193's enrollment target sits among peer trials
218 10th of 29 higher than 20 of 29 other Lupus Erythematosus, Systemic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Erythematosus, Systemic 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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