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NCT01753401 · ClinicalTrials.gov registry record · Phase 4
Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease
A Phase 4 study of Systemic Lupus Erythematosus (SLE), sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
- 20
- Study locations
NCT01753401: Completed Phase 4 study of Systemic Lupus Erythematosus (SLE), sponsored by Mallinckrodt.
NCT01753401 is a Phase 4 study of Systemic Lupus Erythematosus (SLE) that has completed, run by Mallinckrodt. The registered enrollment target is 38 participants, below the 1,062-participant average among 14 other Systemic Lupus Erythematosus (SLE) trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01753401, a Phase 4 study of Systemic Lupus Erythematosus (SLE), has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 4 study is being performed to examine the effects of Acthar for the indicated use of treatment of SLE. This study will enroll patients with steroid-dependent, persistently active SLE with arthritic and/or cutaneous involvement. The study will involve two periods: an 8-week double-blind period, to provide placebo-controlled safety, efficacy, and pharmacodynamic data, and an optional open-label period, to examine the prolonged effects of Acthar maintenance.
Primary Outcome
Participants are counted as responders based on two SLE indices: the Systemic Lupus Erythematosus Disease Activity Index amended by the SELENA group (SELENA-SLEDAI) and the British Isles Lupus Assessment Group (BILAG) Index. * decrease in SELENA-SLEDAI score from 4 to 0 for the arthritis descriptor (highest possible score is 4) and no worsening in other organ systems based on BILAG OR * decrease in SELENA-SLEDAI score from 2 to 0 for rash (highest possible score is 2) and no worsening in othe
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Acthar
- DRUG Steroid Drug
Study Locations (20)
Florida
- Mallinckrodt Investigational Site - Brandon
- Mallinckrodt Investigational Site - Clearwater
- Mallinckrodt Investigational Site - Miami Lakes
- Mallinckrodt Investigational Site - Orlando
- Mallinckrodt Investigational Site - Tampa
California
- Mallinckrodt Investigational Site - La Jolla
- Mallinckrodt Investigational Site - La Palma
- Mallinckrodt Investigational Site - Long Beach
- Mallinckrodt Investigational Site - Upland
New York
- Mallinckrodt Investigational Site - Brooklyn
- Mallinckrodt Investigational Site - Great Neck
- Mallinckrodt Investigational Site - New York
Michigan
- Mallinckrodt Investigational Site - Lansing
- Mallinckrodt Investigational Site - Lansing
Pennsylvania
- Mallinckrodt Investigational Site - Hershey
- Mallinckrodt Investigational Site - Wyomissing
Arkansas
- Mallinckrodt Investigational Site - Jonesboro
Indiana
- Mallinckrodt Investigational Site - Granger
Louisiana
- Mallinckrodt Investigational Site - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-10 |
| Phase | Phase 4 |
What the finished NCT01753401 record still lists
NCT01753401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,062-participant average among 14 other Systemic Lupus Erythematosus (SLE) trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Systemic Lupus Erythematosus (SLE) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01753401 names 20 study sites across 9 states, led by Florida, California, New York.
Frequently Asked Questions
What is clinical trial NCT01753401 about?
NCT01753401 is a clinical study titled "Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease". This Phase 4 study is being performed to examine the effects of Acthar for the indicated use of treatment of SLE. This study will enroll patients with steroid-dependent, persistently active SLE with arthritic and/or cutaneous involvement. The study will involve two periods: an 8-week double-blind p...
What is the current status of trial NCT01753401?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2013-01. Estimated completion is 2015-10.
What conditions does trial NCT01753401 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus (SLE).
What interventions are being tested in trial NCT01753401?
The interventions under investigation include: Placebo (DRUG), Acthar (DRUG), Steroid Drug (DRUG).
Who is sponsoring clinical trial NCT01753401?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01753401 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Lupus Erythematosus (SLE)
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 NCT01753401's enrollment target sits among peer trials
38 11th of 14 higher than 4 of 14 other Systemic Lupus Erythematosus (SLE) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus (SLE) 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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