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

PHASE4CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Systemic Lupus Erythematosus (SLE)
Interventions
DRUG

Acthar

Acthar is given by subcutaneous (SC) injection (shot under the skin), at a dose of 40 units daily or 80 units every other day

DRUG

Placebo

Placebo contains the same inactive ingredients as Acthar, and is given by SC injection

DRUG

Steroid Drug

The patient's steroid regimen 7.5 to 30 mg/day of prednisone or equivalent, chronic/stable within the 4 weeks prior to screening.

Trial Locations (22)

10016

Mallinckrodt Investigational Site, New York

11020

Mallinckrodt Investigational Site, Great Neck

11201

Mallinckrodt Investigational Site, Brooklyn

17033

Mallinckrodt Investigational Site, Hershey

19610

Mallinckrodt Investigational Site, Wyomissing

28210

Mallinckrodt Investigational Site, Charlotte

32806

Mallinckrodt Investigational Site, Orlando

33014

Mallinckrodt Investigational Site, Miami Lakes

33511

Mallinckrodt Investigational Site, Brandon

33614

Mallinckrodt Investigational Site, Tampa

33765

Mallinckrodt Investigational Site, Clearwater

46530

Mallinckrodt Investigational Site, Granger

48910

Mallinckrodt Investigational Site, Lansing

48917

Mallinckrodt Investigational Site, Lansing

70809

Mallinckrodt Investigational Site, Baton Rouge

72401

Mallinckrodt Investigational Site, Jonesboro

77004

Mallinckrodt Investigational Site, Houston

77034

Mallinckrodt Investigational Site, Houston

90623

Mallinckrodt Investigational Site, La Palma

90806

Mallinckrodt Investigational Site, Long Beach

91786

Mallinckrodt Investigational Site, Upland

92037

Mallinckrodt Investigational Site, La Jolla

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mallinckrodt

INDUSTRY