Clinical trial NCT03082573: Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel
Official title: Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Were Treated With H.P. Acthar Gel After an Incomplete Response to Combinations of DMARDs and Biologic DMRADs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Iraj Sabahi Research Inc.
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2017-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: ACR 20 response ACR 20 response
timeFrame: Baseline to week 12
Secondary outcomes:
measure: ACR 50 response
timeFrame: Baseline to week 24
measure: ACR 70 response
timeFrame: Baseline to week 24
measure: EULAR moderate response
timeFrame: Baseline to week 24
measure: EULAR good response
timeFrame: Baseline to week 24
measure: Resolution of Powered Doppler Signal of MSKUS studies
timeFrame: Baseline to week 24
measure: Resolution of signs of active inflammation in MRI
timeFrame: Baseline to week 24
measure: Reduction in Vectra DA Score
timeFrame: Baseline to week 24
measure: Correlation between MSKUS and MRI Imaging findings
timeFrame: Baseline to week 24
measure: Correlation between imaging findings and Vectra DA test
timeFrame: Baseline to week 24
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Iraj Sabahi Research Inc
state: California
city: Turlock
country: United States
facility: Iraj Sabahi Research Inc
state: California
Study officials:
affiliation: Iraj Sabahi Research Inc.
name: Iraj Sabahi, MD
role: PRINCIPAL_INVESTIGATOR
References: