Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease
NCT ID: NCT01753401
Last Updated: 2020-02-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
38 participants
INTERVENTIONAL
2013-01-31
2015-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Period 2: Placebo/Acthar
Participants receive Placebo in Part 1, but after completion of Week 8 in the double-blind phase, patients who received Placebo may choose to participate in the optional open-label phase where they will receive an Acthar maintenance regimen for 44 weeks. The initial Acthar regimen will be assigned based on the study medication regimen the patient received at the completion of the double-blind phase (Visit 6, Week 8). Acthar regimen during Part 2 may be adjusted based on the Investigator's judgment with the goal of achieving a stable Acthar regimen no later than Week 28. Once the stable Acthar regimen is achieved, the Investigator should consider tapering the steroid regimen to a low daily dose or completely discontinue.
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
Placebo
Placebo contains the same inactive ingredients as Acthar, and is given by SC injection
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.
Period 2: Acthar/Acthar
After completion of Week 8 in the double-blind phase, patients who received Acthar may choose to participate in the optional open-label phase where they will receive an Acthar maintenance regimen for 44 weeks. The initial Acthar regimen will be assigned based on the study medication regimen the patient received at the completion of the double-blind phase (Visit 6, Week 8). Acthar regimen may be adjusted based on the Investigator's judgment with the goal of achieving a stable Acthar regimen no later than Week 28. Once the stable Acthar regimen is achieved, the Investigator should consider tapering the steroid regimen to a low daily dose or completely discontinue.
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
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.
Period 1: Placebo
Participants receive matching placebo (in 0.5 mL daily or in 1 mL every other day) for 4 weeks. In Weeks 5-8, they will taper the study medication. Participants will continue on their stable steroid regimen during this phase of the study. After completion of Week 8 in the double-blind phase, they may choose to participate in the optional open-label phase. Participants will continue on their stable steroid regimen during this phase of the study.
Placebo
Placebo contains the same inactive ingredients as Acthar, and is given by SC injection
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.
Period 1: Acthar
Participants receive Acthar (40 units in 0.5 mL daily or 80 units in 1 mL every other day) for 4 weeks. In Weeks 5-8, they will taper the study medication. Participants will continue on their stable steroid regimen during this phase of the study. After completion of Week 8 in the double-blind phase, they may choose to participate in the optional open-label phase. Participants will continue on their stable steroid regimen during this phase of the study.
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
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.
Interventions
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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
Placebo
Placebo contains the same inactive ingredients as Acthar, and is given by SC injection
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of SLE according to the American College of Rheumatology revised criteria (fulfilled ≥ 4 criteria)
* Active SLE with arthritic and/or cutaneous involvement as demonstrated by a SELENA-SLEDAI score ≥ 2 (clinical manifestation must include rash and/or arthritis)
* Moderate to severe rash and/or arthritis as demonstrated by BILAG score A or B in the mucocutaneous and/or musculoskeletal body systems
* Documented history of autoantibodies to at least one of the following: anti-dsDNA, anti-Smith, or anti-cardiolipin
* Documented history of positive antinuclear antibody (ANA)
* Currently on a stable dose of prednisone (7.5 to 30 mg/day of prednisone or equivalent within the 4 weeks prior to screening). The prednisone regimen must remain stable through the double-blind phase and until the stable Acthar regimen is attained in the open-label phase.
Exclusion Criteria
* Patients with active nephritis defined as serum creatinine \> 2.5 mg/dL or protein creatinine ratio (PCR) \> 1.5 g/g, or patients that required hemodialysis within 3 months prior to screening
* Active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis), requiring therapeutic intervention within 3 months prior to screening
* Type 1 or type 2 diabetes mellitus (history of gestational diabetes mellitus is not an exclusion), or patients currently taking hypoglycemic medication
* History of using certain medications prior to screening:
1. oral prednisone (or equivalent) \> 30 mg/day, any steroid injection, cyclosporine, or non-biologic investigational drug within 3 months prior to screening
2. intravenous immunoglobulin (IVIg) or plasmapheresis within 4 months prior to screening
3. cyclophosphamide within 6 months prior to screening; and/or
4. B-cell targeted therapy, abatacept, or any biologic investigational agent within 12 months prior to screening
* Contraindication per Acthar Prescribing Information: scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenal cortical hyperfunction
1. For the purposes of this study, osteoporosis is defined as evidence of vertebral or long bone fracture or vertebral T-score \> 2.0
2. For the purposes of this study, history of peptic ulcer is defined as ≤ 6 months prior to screening
3. For the purposes of this study, congestive heart failure is defined as New York Heart Association Functional Class III-IV
18 Years
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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Mallinckrodt Investigational Site
Jonesboro, Arkansas, United States
Mallinckrodt Investigational Site
La Jolla, California, United States
Mallinckrodt Investigational Site
La Palma, California, United States
Mallinckrodt Investigational Site
Long Beach, California, United States
Mallinckrodt Investigational Site
Upland, California, United States
Mallinckrodt Investigational Site
Brandon, Florida, United States
Mallinckrodt Investigational Site
Clearwater, Florida, United States
Mallinckrodt Investigational Site
Miami Lakes, Florida, United States
Mallinckrodt Investigational Site
Orlando, Florida, United States
Mallinckrodt Investigational Site
Tampa, Florida, United States
Mallinckrodt Investigational Site
Granger, Indiana, United States
Mallinckrodt Investigational Site
Baton Rouge, Louisiana, United States
Mallinckrodt Investigational Site
Lansing, Michigan, United States
Mallinckrodt Investigational Site
Lansing, Michigan, United States
Mallinckrodt Investigational Site
Brooklyn, New York, United States
Mallinckrodt Investigational Site
Great Neck, New York, United States
Mallinckrodt Investigational Site
New York, New York, United States
Mallinckrodt Investigational Site
Charlotte, North Carolina, United States
Mallinckrodt Investigational Site
Hershey, Pennsylvania, United States
Mallinckrodt Investigational Site
Wyomissing, Pennsylvania, United States
Mallinckrodt Investigational Site
Houston, Texas, United States
Mallinckrodt Investigational Site
Houston, Texas, United States
Countries
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References
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Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Other Identifiers
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QSC01-SLE-01
Identifier Type: -
Identifier Source: org_study_id
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