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

NCT03082573 | Unknown Phase 4 FDA Drug

• 1 other identifier: IS2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• ACR 20 response ACR 20 response

  Equal or greater than 20 % reduction in RA disease activity

  Baseline to week 12

Secondary Outcomes (9)

• ACR 50 response

  Baseline to week 24

• ACR 70 response

  Baseline to week 24

• EULAR moderate response

  Baseline to week 24

• EULAR good response

  Baseline to week 24

• Resolution of Powered Doppler Signal of MSKUS studies

  Baseline to week 24

Study Arms (2)

Group A

ACTIVE COMPARATOR

Will be receiving the same background medications and H.P. Acthar gel 40 units twice weekly for 12 weeks. Patients in group A, can be cross over to group B on week 13 if disease is uncontrolled for continuation until week 24. If their disease is under control then they will continue with the same dosage until week 24. If the disease is under control, then tapering the steroid dosage can be attempted at the principal investigation's discretion.

Drug: H.P. Acthar gel

Group B

ACTIVE COMPARATOR

Will be receiving the same background medications and H.P. Acthar gel 80 units twice weekly for 12 weeks. if the disease is not under control, will continue with same dosage until week 24. If the disease is under control, will be given the option to reduce the dosage to 40 units twice weekly only if patient is suffering from H.P. Acthar gel related adverse effects. If the disease is under control, then tapering the steroid dosage can be attempted at the principal investigation's discretion.

Drug: H.P. Acthar gel

Interventions

H.P. Acthar gel DRUG

H.P. Acthar gel in treatment of Refractory RA

Also known as: Repository Corticotropin Injection

Group A; Group B

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Iraj Sabahi Research Inc.: lead
• Mallinckrodt: collaborator

Study Sites (2)

Iraj Sabahi Research Inc

Pleasanton, California, 94588, United States

RECRUITING

Iraj Sabahi Research Inc

Turlock, California, 95382, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Iraj Sabahi, MD

  Iraj Sabahi Research Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iraj Sabahi, MD

CONTACT

925-264-7100; irajsabahi2015@gmail.com

Sonia Dimas

CONTACT

209-634-3898; irajsabahi2015@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 17, 2017
• Study Start: March 3, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2019
• Last Updated: March 17, 2017

Record last verified: 2017-03

Locations

US (2)