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NCT02708095 · ClinicalTrials.gov registry record · Phase 2
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)
A Phase 2 study of Systemic Lupus Erythematosus, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 314
- Enrollment target
- 20
- Study locations
NCT02708095: Completed Phase 2 study of Systemic Lupus Erythematosus, sponsored by Eli Lilly and Company.
NCT02708095 is a Phase 2 study of Systemic Lupus Erythematosus that has completed, run by Eli Lilly and Company. The registered enrollment target is 314 participants, below the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02708095, a Phase 2 study of Systemic Lupus Erythematosus, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 314 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.
Primary Outcome
Participants were defined as responder as follows using SLEDAI-2K definitions of arthritis and rash. If only arthritis is present at baseline, then arthritis must be absent at Week 24 to meet the primary endpoint. If only rash is present at baseline, then rash must be absent at Week 24 to meet the primary endpoint. If both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Baricitinib
Study Locations (20)
California
- Wallace Rheumatic Study Center - Beverly Hills
- Medvin Clinical Research - Covina
- TriWest Research Assocaites - El Cajon
- University of California - La Jolla
- Desert Medical Advances - Palm Desert
- Inlande Rheumatology Clinical Trials - Upland
Florida
- New Horizon Research Center - Miami
- West Broward Rheumatology Associates, Inc - Tamarac
- Clinical Research of West Florida, Inc. - Tampa
Louisiana
- The Arthritis & Diabetes Clinic Inc. - Monroe
- Louisiana State University Health Sciences Center - Shreveport
Missouri
- Clayton Medical Research - St Louis
- Arthritis Consultants - St Louis
Arizona
- University of Arizona - Tucson
Colorado
- Denver Arthritis Center - Denver
Kansas
- Kansas City Internal Medicine Research - Overland Park
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2016-03-24 |
| Est. Completion | 2017-11-09 |
| Phase | Phase 2 |
What the finished NCT02708095 record still lists
NCT02708095 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, below the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02708095 names 20 study sites across 11 states, led by California, Florida, Louisiana.
Frequently Asked Questions
What is clinical trial NCT02708095 about?
NCT02708095 is a clinical study titled "A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)". The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.
What is the current status of trial NCT02708095?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 314 participants. The study started on 2016-03-24. Estimated completion is 2017-11-09.
What conditions does trial NCT02708095 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT02708095?
The interventions under investigation include: Placebo (DRUG), Baricitinib (DRUG).
Who is sponsoring clinical trial NCT02708095?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02708095 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Lupus Erythematosus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02708095's enrollment target sits among peer trials
314 27th of 99 higher than 72 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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