Clinical trial NCT02258217: Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)
Official title: Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: OhioHealth
Sponsor class: OTHER
First posted: 2014-10-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 identified during routine clinical evaluations. If patient is determined to be having a study-defined MS relapse, they will be invited to participate in this study. After consent is obtained, the patient will complete the first page of the ARMS survey. If prior steroid use was deemed tolerable then only the first page of the ARMS will be collected and analyzed and these patients will complete their participation in the trial. Their data from the ARMS will provide an estimate as to the number of patients who self-report tolerability and efficacy issues with steroids. However, if patients self-report prior steroid intolerability, then they will advance into the Acthar treatment arm of the trial.

Eligibility criteria: Inclusion Criteria:

1. Subjects who have volunteered and consented to participate in the study.
2. Subjects who have no contraindication to taking high dose, oral prednisone or Acthar.
3. Male or Female subjects age 18 or greater years of age.
4. Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) based on 2010 McDonald Criteria.
5. 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).
6. Subjects who are experiencing a protocol defined MS relapse within two weeks of relapse onset.
7. Subjects who are able and willing to sign a consent form.

Exclusion Criteria:

1. Subjects who are less than 18 years of age.
2. Subjects with any contraindication to taking Acthar.
3. 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).
4. Subjects with an immune deficiency.
5. Subjects with a history of any of the following conditions: gastrointestinal ulcers, diabetes mellitus, gestational diabetes, malignant hypertension or steroid induced psychosis.
6. Subjects who are pregnant or breastfeeding.
7. Subjects who are unable or unwilling to sign consent form.
8. Patient is unable or unwilling to participate in phone and clinic follow up.
9. Other factors that in the opinion of the Principal Investigator would exclude the subject from participation in the study.

Primary outcomes:
measure: ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living)
timeFrame: baseline visit & follow-up after treatment
measure: ARMS (Assessing Relapses in Multiple Sclerosis) RSH Scores (Return to Previous Health)
timeFrame: baseline visit & follow-up after treatment
measure: ARMS (Assessing Relapses in Multiple Sclerosis) TCS Scores (Total Composite Scores)
timeFrame: Follow-up visit
measure: ARMS (Assessing Relapses in Multiple Sclerosis) PCS Scores (Partial Composite Scores)
timeFrame: baseline visit & follow-up after treatment
measure: MSIS (Multiple Sclerosis Impact Scale) -29 Physical Score
timeFrame: baseline visit & follow-up after treatment
measure: MSIS (Multiple Sclerosis Impact Scale) - 29 Psychological Score.
timeFrame: baseline visit & follow-up after treatment
measure: EDSS (Expanded Disability Status Scale) Scores.
timeFrame: baseline and at follow-up
measure: SAGE (Self-administered Gerocognitive Exam) Scores
timeFrame: baseline and follow-up
Secondary outcomes:
measure: GASE Scale Questionnaire (Generic Assessment of Side Effects)
timeFrame: 1 week
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OhioHealth
state: Ohio
Study officials:
affiliation: OhioHealth
name: Aaron L Boster, MD
role: PRINCIPAL_INVESTIGATOR
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