Back to resultsEfficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
H.P. Acthar gel
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Sites / Locations
- Iraj Sabahi Research IncRecruiting
- Iraj Sabahi Research IncRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
ACR 20 response ACR 20 response
Equal or greater than 20 % reduction in RA disease activity
Secondary Outcome Measures
ACR 50 response
Equal or greater than 50 % reduction in RA disease activity
ACR 70 response
Equal or greater than 70 % reduction in RA disease activity
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).
EULAR good response
Decline in DAS 28 score must exceed 1.2 and result in the achievement of low disease activity (DAS28 <3.2).
Resolution of Powered Doppler Signal of MSKUS studies
Decline or resolution of synovitis detected in ultra sonographic examination of joints
Resolution of signs of active inflammation in MRI
Decline or resolution of synovitis, tenosynovitis or bone edema detected in MRI examination of joints
Reduction in Vectra DA Score
Decline in RA disease activity manifested as decline in Vectra DA Score
Correlation between MSKUS and MRI Imaging findings
Comparison between MSKUS and MRI imaging
Correlation between imaging findings and Vectra DA test
Comparison between MSKUS/MRI findings and Vectra DA test results
Full Information
NCT ID
NCT03082573
First Posted
March 13, 2017
Last Updated
March 16, 2017
Sponsor
Iraj Sabahi Research Inc.
Collaborators
Mallinckrodt
1. Study Identification
Unique Protocol Identification Number
NCT03082573
Brief Title
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iraj Sabahi Research Inc.
Collaborators
Mallinckrodt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
H.P. Acthar gel
Other Intervention Name(s)
Repository Corticotropin Injection
Intervention Description
H.P. Acthar gel in treatment of Refractory RA
Primary Outcome Measure Information:
Title
ACR 20 response ACR 20 response
Description
Equal or greater than 20 % reduction in RA disease activity
Time Frame
Baseline to week 12
Secondary Outcome Measure Information:
Title
ACR 50 response
Description
Equal or greater than 50 % reduction in RA disease activity
Time Frame
Baseline to week 24
Title
ACR 70 response
Description
Equal or greater than 70 % reduction in RA disease activity
Time Frame
Baseline to week 24
Title
EULAR moderate response
Description
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).
Time Frame
Baseline to week 24
Title
EULAR good response
Description
Decline in DAS 28 score must exceed 1.2 and result in the achievement of low disease activity (DAS28 <3.2).
Time Frame
Baseline to week 24
Title
Resolution of Powered Doppler Signal of MSKUS studies
Description
Decline or resolution of synovitis detected in ultra sonographic examination of joints
Time Frame
Baseline to week 24
Title
Resolution of signs of active inflammation in MRI
Description
Decline or resolution of synovitis, tenosynovitis or bone edema detected in MRI examination of joints
Time Frame
Baseline to week 24
Title
Reduction in Vectra DA Score
Description
Decline in RA disease activity manifested as decline in Vectra DA Score
Time Frame
Baseline to week 24
Title
Correlation between MSKUS and MRI Imaging findings
Description
Comparison between MSKUS and MRI imaging
Time Frame
Baseline to week 24
Title
Correlation between imaging findings and Vectra DA test
Description
Comparison between MSKUS/MRI findings and Vectra DA test results
Time Frame
Baseline to week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iraj Sabahi, MD
Phone
925-264-7100
Email
irajsabahi2015@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia Dimas
Phone
209-634-3898
Email
irajsabahi2015@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iraj Sabahi, MD
Organizational Affiliation
Iraj Sabahi Research Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iraj Sabahi Research Inc
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iraj Sabahi, MD
Phone
925-264-7100
Email
irajsabahi2015@gmail.com
First Name & Middle Initial & Last Name & Degree
Sonia Dimas
Phone
209-634-3898
Email
irajsabahi2015@gmail.com
Facility Name
Iraj Sabahi Research Inc
City
Turlock
State/Province
California
ZIP/Postal Code
95382
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iraj Sabahi, MD
Phone
925-264-7100
Email
irajsabahi2015@gmail.com
First Name & Middle Initial & Last Name & Degree
Sonia Dimas
Phone
209-634-3898
Email
irajsabahi2015@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel
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