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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03082573
• Date of registration: 13/03/2017
• Prospective Registration: No
• Primary sponsor: Iraj Sabahi Research Inc.
• Public title: Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel
• Scientific 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
• Date of first enrolment: March 3, 2017
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03082573
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Iraj Sabahi, MD
• Affiliation: Iraj Sabahi Research Inc.

• Name: Iraj Sabahi, MD

Key inclusion & exclusion 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.



Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: H.P. Acthar gel

Primary Outcome(s)

ACR 20 response ACR 20 response [Time Frame: Baseline to week 12]

Secondary Outcome(s)

EULAR good response [Time Frame: Baseline to week 24]

EULAR moderate response [Time Frame: Baseline to week 24]

Resolution of signs of active inflammation in MRI [Time Frame: Baseline to week 24]

ACR 70 response [Time Frame: Baseline to week 24]

Correlation between imaging findings and Vectra DA test [Time Frame: Baseline to week 24]

Reduction in Vectra DA Score [Time Frame: Baseline to week 24]

Correlation between MSKUS and MRI Imaging findings [Time Frame: Baseline to week 24]

ACR 50 response [Time Frame: Baseline to week 24]

Resolution of Powered Doppler Signal of MSKUS studies [Time Frame: Baseline to week 24]

Secondary ID(s)

IS2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mallinckrodt