Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus

Exclusion Criteria

• •Any of the following would exclude the subject from participation in the study:
• •1. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or confound interpretation of subject safety or study results
• •2. Concurrent enrollment in any other clinical study with an investigational product with 4 weeks (28 days) prior to Day 0 or within 5 half-lives of the investigational product used in that clinical study, whichever is longer
• •3. Employees of the clinical study site or any other individuals involved with the conduct of the study or immediate family members of such individuals
• •4. Any new oral prednisone therapy (or equivalent) or any change in current oral prednisone dose (or equivalent) anytime from 4 weeks (28 days) prior to signing of the informed consent
• •5. A known history of allergy or reaction to any component of the investigational product
• •6. Any live or attenuated vaccine within 4 weeks (28 days) prior to signing the informed consent form (administration of killed vaccines is acceptable)
• •7. Diagnosis of scleroderma, osteoporosis, fungal infections, ocular herpes simplex, surgery within the past 4 weeks (28 days) or planned surgery within the next 4 weeks (28 days)
• •8. History of or presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency or adrenocortical hyperfunction or sensitivity to proteins of porcine origin
• •9. Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus (HIV) infection or splenectomy that predisposes the subject to infection
• •10. History of any type of malignancy \<5 years before randomization into the study (apart from basal cell carcinoma)
• •11. Receipt of more than one prescribed NSAID at an anti-inflammatory dose with 4 weeks (28 days) prior to Day 0
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