Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02633033
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2015-12-15
Brief Title:
Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse
Sponsor:
Mallinckrodt
Organization:
Mallinckrodt
Study Overview
Official Title:
A Prospective Observational Registry of HP Acthar Gel for the Treatment of Multiple Sclerosis Relapse
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
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:
Acthar Gel was first approved by the Food and Drug Administration in 1952
It has been used to treat many different illnesses including multiple sclerosis
This study will observe how treatment with Acthar affected the daily lives of patients who suffer with relapsingremitting MS
It will collect information on symptoms recovery treatment patterns and safety outcomes
It has been used to treat many different illnesses including multiple sclerosis
This study will observe how treatment with Acthar affected the daily lives of patients who suffer with relapsingremitting MS
It will collect information on symptoms recovery treatment patterns and safety outcomes
Detailed Description:
Acthar Gel repository corticotropin injection contains a non-bovine analogue of adrenocorticotropic hormone ACTH for intramuscular or subcutaneous use
It was initially approved by the FDA in 1952 and is used for multiple indications
This registry will evaluate the use of Acthar Gel for the treatment of MS exacerbations in the United States
It was initially approved by the FDA in 1952 and is used for multiple indications
This registry will evaluate the use of Acthar Gel for the treatment of MS exacerbations in the United States
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None