Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel

Rheumatoid arthritis (RA) is a systemic inflammatory disease which causes premature
mortality, disability and compromised quality of life in the industrialized and developing
world. The prevalence of RA is believed to range from 0.5-1.0% in the general population.
Over the past half century, many studies have found mortality to be increased in patients
with established RA in comparison with the general population. Despite available treatment
options for RA, some patients still have disease that is refractory to treatment and cannot
achieve remission.

H.P. Acthar gel (adrenocorticotropic hormone gel) received FDA approval for treatment of a
variety of diseases, including RA in 1952. The proposed efficacy of H.P. Acthar gel has been
attributed to its ability to induce production of endogenous steroids and to bind
melanocortin receptors on lymphocytes and other cells to modulate immunologic responses. The
present study will examine the clinical response, cytokine production and joint imaging
after addition of H.P. Acthar gel to confirm the efficacy, confirm different mechanism of
action in comparison to steroids and other DMARDs by looking for post treatment changes in
cytokine expression.

Inclusion Criteria:

1. Patients with diagnosis of RA with incomplete or failure to treatment described as
either A or B A: Failure to achieve remission or low disease activity within 3 to 6
months of treatment with combination of methotrexate or other DMARDs therapy with a
biologic DMARD in maximally tolerated doses within the usual therapeutic range.

B- A requirement, in addition to DMARDs and biologic DMARDs, for chronic
glucocorticoid therapy in a dose of greater than about 5 to 7.5 mg/day of prednisone
or equivalent to achieve or maintain remission or low disease activity after 3 to 6
months of treatment.

2. Fluent in reading and writing in English language.

3. ≥ 21 years of age at the time of participation.

Exclusion Criteria:

1. Pregnancy

2. Presence if contraindications for treatment with H.P. Acthar gel including but not
limited to any known history of scleroderma, osteoporosis, systemic fungal
infections, ocular Herpes Simplex, recent administration of live or live attenuated
vaccine (prior 6 months), recent surgery (prior 6 months), history of or the presence
of a peptic ulcer, primary adrenocortical insufficiency, adrenal cortical
hyperfunction; congestive heart failure (defined as New York Hear Association
Functional Class I to IV, uncontrolled hypertension.

3. Previous use of ACTH preparations for treatment of nephrotic syndrome (including but
not limited to H.P. Acthar gel and Synacthen®).

4. Previous history of sensitivity to ACTH preparations (including but not limited to
H.P. Acthar gel and Synacthen®).

5. Previous history of sensitivity to porcine protein products.