Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)

OhioHealth30 enrolled

Overview

Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Relapsing Remitting Multiple Sclerosis

Interventions

ActharDRUG

Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

OhioHealth

Columbus, Ohio, United States

Outcomes

Primary Outcomes

ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living)

Patient history of prior corticosteroid tolerability for the treatment of MS relapses. This will be determined based on patient completion of the ARMS survey at the baseline visit. Also, history of patients from the survey after treatment for the new relapse will be collected. The ARMS questionnaire (assessing relapses in multiple sclerosis) was developed by a panel of expert MS nurses. Part one consists of 7 questions designed to assess relapse symptoms, impact on activities of daily living, and response to past treatment for MS relapses. Part two consists of 7 questions to evaluate treatment response in terms of relief from symptoms, functioning and tolerability. ADL scores were calculated from Part 1 (new relapse), question 3 and Part 2 (after treatment of relapse), question 5 both specifically refer to ADL; Scale: ADL (Activities of Daily Living) Minimum value: 0 Maximum value: 9 Higher scores indicated better functioning/ improvement.

Time frame: baseline visit & follow-up after treatment

ARMS (Assessing Relapses in Multiple Sclerosis) RSH Scores (Return to Previous Health)

Patient history of prior corticosteroid tolerability for the treatment of MS relapses. This will be determined based on patient completion of the ARMS survey at the baseline visit. Also, patients completed the survey after treatment for the new relapse. The ARMS questionnaire (assessing relapses in multiple sclerosis) was developed by a panel of expert MS nurses. Part one consists of 7 questions designed to assess relapse symptoms, impact on activities of daily living, and response to past treatment for MS relapses. Part two consists of 7 questions to evaluate treatment response in terms of relief from symptoms, functioning and tolerability. Part 1 (new relapse) \& Part 2 (after treatment of new relapse), question 6 were used to calculate RSH; Scale: RSH (Return to previous health) Minimum value: -1 Maximum value: 10 Higher scores indicating a more complete return to previous state of health.

Time frame: baseline visit & follow-up after treatment

ARMS (Assessing Relapses in Multiple Sclerosis) TCS Scores (Total Composite Scores)

Patients completed the ARMS survey after treatment for the new relapse.The ARMS questionnaire (assessing relapses in multiple sclerosis) was developed by a panel of expert MS nurses. Part one consists of 7 questions designed to assess relapse symptoms, impact on activities of daily living, and response to past treatment for MS relapses. Part two consists of 7 questions to evaluate treatment response in terms of relief from symptoms, functioning and tolerability. The TCS score was calculated only for the time point after treatment of relapse. It was a sum of questions 4 (symptom improvement), 5 (ADL), and 6 (return to previous state of health (RSH)) were evaluated. Scores range from 0 to 30 units, with higher scores representing greater improvement/better functioning.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.