Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease
Condition: Systemic Lupus Erythematosus (SLE)
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Acthar; Placebo; Steroid Drug
Intervention description: 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 contains the same inactive ingredients as Acthar, and is given by SC injection; The patient's steroid regimen 7.5 to 30 mg/day of prednisone or equivalent, chronic/stable within the 4 weeks prior to screening.
Intervention MeSH terms: Prednisone; Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SLE; Lupus

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 years of age at screening who are able to provide informed consent

          -  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 a recent history (≤ 2 months prior to screening) of starting prednisone
             (or equivalent) use

          -  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