Status:
COMPLETED
Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)
Lead Sponsor:
OhioHealth
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)
Detailed Description
We propose to conduct a prospective, single-center, open-label, single-arm study comparing tolerability of Acthar versus oral prednisone in the treatment of MS relapses. Potential subjects will be ide...
Eligibility Criteria
Inclusion
- Subjects who have volunteered and consented to participate in the study.
- Subjects who have no contraindication to taking high dose, oral prednisone or Acthar.
- Male or Female subjects age 18 or greater years of age.
- Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) based on 2010 McDonald Criteria.
- Subjects without an active infection (Note: If a patient is found to have an uncomplicated UTI and agrees to start on appropriate antibiotic treatment, they can continue in the study).
- Subjects who are experiencing a protocol defined MS relapse within two weeks of relapse onset.
- Subjects who are able and willing to sign a consent form.
Exclusion
- Subjects who are less than 18 years of age.
- Subjects with any contraindication to taking Acthar.
- Subjects with an active infection other than an uncomplicated urinary tract infection (UTI) (subjects determined to have a UTI who agree to be treated with appropriate antibiotics will not be excluded).
- Subjects with an immune deficiency.
- Subjects with a history of any of the following conditions: gastrointestinal ulcers, diabetes mellitus, gestational diabetes, malignant hypertension or steroid induced psychosis.
- Subjects who are pregnant or breastfeeding.
- Subjects who are unable or unwilling to sign consent form.
- Patient is unable or unwilling to participate in phone and clinic follow up.
- Other factors that in the opinion of the Principal Investigator would exclude the subject from participation in the study.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02258217
Start Date
June 1 2014
End Date
December 1 2016
Last Update
September 1 2020
Active Locations (1)
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1
OhioHealth
Columbus, Ohio, United States, 43214