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Corticosteroid
Group A for Rheumatoid Arthritis
Phase 4
Waitlist Available
Led By Iraj Sabahi, MD
Research Sponsored by Iraj Sabahi Research Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24
Awards & highlights
Study 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.
Eligible Conditions
- Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ACR 20 response ACR 20 response
Secondary outcome measures
ACR 50 response
ACR 70 response
Correlation between MSKUS and MRI Imaging findings
+6 moreTrial Design
2Treatment groups
Active Control
Group I: Group AActive Control1 Intervention
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.
Group II: Group BActive Control1 Intervention
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.
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Who is running the clinical trial?
Iraj Sabahi Research Inc.Lead Sponsor
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
16,198 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
135 Patients Enrolled for Rheumatoid Arthritis
Iraj Sabahi, MDPrincipal InvestigatorIraj Sabahi Research Inc.
Frequently Asked Questions
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