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Completed Phase 4 Interventional Results available

Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease

ClinicalTrials.gov ID: NCT01753401

Public ClinicalTrials.gov record NCT01753401. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 8:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Two-part Study Exploring the Efficacy, Safety, and Pharmacodynamics of Acthar in Systemic Lupus Erythematosus Patients With a History of Persistently Active Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01753401
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Mallinckrodt
Industry
Enrollment
38 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2012
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015
Last update posted
Feb 26, 2020

2013 – 2015

United States locations

U.S. sites
22
U.S. states
10
U.S. cities
20
Facility City State ZIP Site status
Mallinckrodt Investigational Site Jonesboro Arkansas 72401
Mallinckrodt Investigational Site La Jolla California 92037
Mallinckrodt Investigational Site La Palma California 90623
Mallinckrodt Investigational Site Long Beach California 90806
Mallinckrodt Investigational Site Upland California 91786
Mallinckrodt Investigational Site Brandon Florida 33511
Mallinckrodt Investigational Site Clearwater Florida 33765
Mallinckrodt Investigational Site Miami Lakes Florida 33014
Mallinckrodt Investigational Site Orlando Florida 32806
Mallinckrodt Investigational Site Tampa Florida 33614
Mallinckrodt Investigational Site Granger Indiana 46530
Mallinckrodt Investigational Site Baton Rouge Louisiana 70809
Mallinckrodt Investigational Site Lansing Michigan 48910
Mallinckrodt Investigational Site Lansing Michigan 48917
Mallinckrodt Investigational Site Brooklyn New York 11201
Mallinckrodt Investigational Site Great Neck New York 11020
Mallinckrodt Investigational Site New York New York 10016
Mallinckrodt Investigational Site Charlotte North Carolina 28210
Mallinckrodt Investigational Site Hershey Pennsylvania 17033
Mallinckrodt Investigational Site Wyomissing Pennsylvania 19610
Mallinckrodt Investigational Site Houston Texas 77004
Mallinckrodt Investigational Site Houston Texas 77034

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01753401, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 26, 2020 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01753401 live on ClinicalTrials.gov.

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