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NCT02953821 · ClinicalTrials.gov registry record · Phase 4
Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
A Phase 4 study of Lupus Erythematosus, Systemic, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 4
- Development phase
- 172
- Enrollment target
- 20
- Study locations
NCT02953821: Completed Phase 4 study of Lupus Erythematosus, Systemic, sponsored by Mallinckrodt.
NCT02953821 is a Phase 4 study of Lupus Erythematosus, Systemic that has completed, run by Mallinckrodt. The registered enrollment target is 172 participants, below the 197-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (13% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02953821, a Phase 4 study of Lupus Erythematosus, Systemic, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 172 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE). The doctor will assign eligible patients to one of two groups (like flipping a coin). Participants will receive the treatment assigned to their group for 24 weeks: * Acthar Gel * Placebo Gel, which looks like Acthar Gel, but has no medicine in it. The doctor or his staff will take measurements and ask questions to: * see how well the gel is working * see how safe it is for patients with SLE
Primary Outcome
PGA is a 100 mm visual analogue scale where higher scores indicate more severe disease activity. Lower scores indicate improvement.
Conditions Studied
Interventions
- DRUG Placebo Gel
- DRUG Acthar Gel
Study Locations (20)
Florida
- Center for Rheumatology Immunology and Arthritis - Fort Lauderdale
- San Marcus Research Clinic - Miami
- Advanced Pharma CR - Miami
- Millennium Research - Ormond Beach
Other
- Aprillus Asistencia e Investigación - Buenos Aires
- Consultorios Médicos Dr. Catalán Pellet - Buenos Aires
- Centro Medico Privado de Reumatología - San Miguel de Tucumán
- Biomedica Research Group - Santiago
California
- C.V. Mehta MD Medical Corporation - Hemet
- Inland Rheumatology Clinical Trials - Upland
Tennessee
- West Tennessee Physicians' Alliance - Jackson
- Office of Ramesh C. Gupta, MD - Memphis
Texas
- Accurate Clinical Research - Houston
- Sun Research Institute - San Antonio
Nevada
- Office of George Timothy Kelly MD - Las Vegas
New York
- NewYork-Presbyterian Columbia University Medical Center - New York
North Carolina
- DJL Clinical Research - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2016-12-16 |
| Est. Completion | 2019-10-25 |
| Phase | Phase 4 |
What the finished NCT02953821 record still lists
NCT02953821 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, below the 197-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (13% lower).
The record links to 1 condition, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 2 interventions - of which Placebo Gel is the first listed.
NCT02953821 names 20 study sites across 11 states, led by Florida, Other, California.
Frequently Asked Questions
What is clinical trial NCT02953821 about?
NCT02953821 is a clinical study titled "Acthar Gel for Active Systemic Lupus Erythematosus (SLE)". This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE). The doctor will assign eligible patients to one of two groups (like flipping a coin). Participants will receive the treatment assigned to their group for 24 weeks: * Acthar Gel * Placebo Gel, which l...
What is the current status of trial NCT02953821?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 172 participants. The study started on 2016-12-16. Estimated completion is 2019-10-25.
What conditions does trial NCT02953821 study?
This clinical trial studies the following conditions: Lupus Erythematosus, Systemic.
What interventions are being tested in trial NCT02953821?
The interventions under investigation include: Placebo Gel (DRUG), Acthar Gel (DRUG).
Who is sponsoring clinical trial NCT02953821?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02953821 being conducted?
This trial has 20 study locations across California, Florida, Nevada, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02953821's enrollment target sits among peer trials
172 15th of 29 higher than 15 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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