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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03082573
• Other study ID #: IS2017
• Status: Recruiting
• Phase: Phase 4
• First received: March 13, 2017
• Last updated: March 16, 2017
• Start date: March 3, 2017
• Est. completion date: February 2019

Study information

• Verified date: March 2017
• Source: Iraj Sabahi Research Inc.
• Contact: Iraj Sabahi, MD
• Phone: 925-264-7100
• Email: irajsabahi2015[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• H.P. Acthar gel
H.P. Acthar gel in treatment of Refractory RA

Locations

Country	Name	City	State
United States	Iraj Sabahi Research Inc	Pleasanton	California
United States	Iraj Sabahi Research Inc	Turlock	California

Sponsors (2)

Lead Sponsor	Collaborator
Iraj Sabahi Research Inc.	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR 20 response ACR 20 response	Equal or greater than 20 % reduction in RA disease activity	Baseline to week 12
Secondary	ACR 50 response	Equal or greater than 50 % reduction in RA disease activity	Baseline to week 24
Secondary	ACR 70 response	Equal or greater than 70 % reduction in RA disease activity	Baseline to week 24
Secondary	EULAR moderate response	Decline in the DAS 28 score by >1.2 (without reaching low disease activity) OR The decline of 0.6 to 1.2, plus reaching at least moderate disease activity (DAS28 <5.1).	Baseline to week 24
Secondary	EULAR good response	Decline in DAS 28 score must exceed 1.2 and result in the achievement of low disease activity (DAS28 <3.2).	Baseline to week 24
Secondary	Resolution of Powered Doppler Signal of MSKUS studies	Decline or resolution of synovitis detected in ultra sonographic examination of joints	Baseline to week 24
Secondary	Resolution of signs of active inflammation in MRI	Decline or resolution of synovitis, tenosynovitis or bone edema detected in MRI examination of joints	Baseline to week 24
Secondary	Reduction in Vectra DA Score	Decline in RA disease activity manifested as decline in Vectra DA Score	Baseline to week 24
Secondary	Correlation between MSKUS and MRI Imaging findings	Comparison between MSKUS and MRI imaging	Baseline to week 24
Secondary	Correlation between imaging findings and Vectra DA test	Comparison between MSKUS/MRI findings and Vectra DA test results	Baseline to week 24