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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03082573
Date of registration: 13/03/2017
Prospective Registration: Yes
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
Address: 
Telephone: 925-264-7100
Email: irajsabahi2015@gmail.com
Affiliation: 
Name:     Iraj Sabahi, MD
Address: 
Telephone:
Email:
Affiliation:  Iraj Sabahi Research Inc.
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)
ACR 50 response [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]
Correlation between MSKUS and MRI Imaging findings [Time Frame: Baseline to week 24]
EULAR good response [Time Frame: Baseline to week 24]
EULAR moderate response [Time Frame: Baseline to week 24]
Reduction in Vectra DA Score [Time Frame: Baseline to week 24]
Resolution of Powered Doppler Signal of MSKUS studies [Time Frame: Baseline to week 24]
Resolution of signs of active inflammation in MRI [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
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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