Ignite Creation Date:
2024-05-06 @ 9:49 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03082573
Status:
UNKNOWN
Last Update Posted:
2017-03-17
First Post:
2017-03-13
Brief Title:
Efficacy Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With HP Acthar Gel
Sponsor:
Iraj Sabahi Research Inc
Organization:
Iraj Sabahi Research Inc
Study Overview
Official Title:
Open-label Pilot Protocol of Patients With Rheumatoid Arthritis Who Were Treated With HP Acthar Gel After an Incomplete Response to Combinations of DMARDs and Biologic DMRADs
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the clinical response cytokine expression and joint imaging after addition of Acthar Gel The hypothesis is that HP 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 05-10 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
HP Acthar gel adrenocorticotropic hormone gel received FDA approval for treatment of a variety of diseases including RA in 1952 The proposed efficacy of HP 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 HP 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
HP Acthar gel adrenocorticotropic hormone gel received FDA approval for treatment of a variety of diseases including RA in 1952 The proposed efficacy of HP 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 HP 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None