Addition of H.P. Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis

Exclusion Criteria

• •Presence of any condition which could confound interpretation of the data, such as inflammatory arthritis (eg. psoriatic arthritis, gout or pseudogout)
• •Presence of systemic fungal infections, recent surgery (within prior 3 months), or active ulcer disease (within the past 5 years)
• •Current symptoms of severe, progressive, or uncontrolled renal, hepatic ,hematologic, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease
• •Have had in last three months or planning to receive live or live attenuated vaccines
• •Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in the study such as uncontrolled diabetes or hypertension
• •History of or presence of active or latent tuberculosis (TB) based on QuantiFERON-TB gold test. Patients will be allowed in the study after receiving adequate treatment for TB
• •Sensitivity to proteins of porcine origin
• •History of cancer within the last 5 years, excluding basal cell carcinoma
• •Glomerular filtration rate \<30 mL/min -
• •Uncontrolled diabetes mellitus
• •Pregnant of lactating female patients. Each site to administer a pregnancy test to any female of childbearing potential before prescribing Acthar Gel. Only females with negative pregnancy test results are eligible. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the period of the study.
• •The following physical and laboratory test findings
• •Patients with positive hepatitis B surface antigen
• •Patients with positive hepatitis C antibody, who are also positive by recombinant immunoblot assay (RIBA) or by polymerase chain reaction (PCR)
• •Hemoglobin level \<8.5. g/dL
• •White blood cell count \<3000/mm (3 x 10/L)
• •Serum Creatinine level \>2 times upper limit of normal
• •Serum alanine aminotransferase (ALT) or asparate amino- transferase (AST) \>2 times upper limit of normal
• •Any other laboratory test results that, in the opinion of the investigator might placed the patient at unacceptable risk for participation in this study