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

Status unconfirmed · Phase 4

Conditions studied: Rheumatoid Arthritis

In brief

This study will examine the clinical response, cytokine expression and joint imaging after addition of Acthar Gel. The hypothesis is that H.P. Acthar Gel is both safe and effective for treatment of patients with refractory rheumatoid arthritis (RA) and has different mechanism of action than steroids and other DMARDs.

Key facts

Study ID

NCT03082573

Run by

Iraj Sabahi Research Inc.

People needed

30

Starts

2017-03-03

Expected to finish

2019-02-01

Last updated by the study team

2017-03-17

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Fluent in reading and writing in English language.
• ≥ 21 years of age at the time of participation.

You may not qualify if…

• Pregnancy
• 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.
• Previous use of ACTH preparations for treatment of nephrotic syndrome (including but not limited to H.P. Acthar gel and Synacthen®).
• Previous history of sensitivity to ACTH preparations (including but not limited to H.P. Acthar gel and Synacthen®).
• Previous history of sensitivity to porcine protein products.

Where it is running

• Iraj Sabahi Research Inc — Pleasanton, California, United States (enrolling)
• Iraj Sabahi Research Inc — Turlock, California, United States (enrolling)

Full record on ClinicalTrials.gov

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