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

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ClinicalTrials.gov Identifier: NCT02258217
Recruitment Status : Completed
First Posted : October 7, 2014
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Aaron Boster, Riverside Methodist Hospital

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

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: Acthar Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)
Study Start Date : June 2014
Actual Primary Completion Date : June 24, 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single arm
Acthar 80 units subcutaneously for five consecutive days.
Drug: Acthar
Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults.
Other Name: repository corticotropin




Primary Outcome Measures :
  1. ARMS (assessing relapses in multiple sclerosis) [ Time Frame: baseline visit ]
    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.


Secondary Outcome Measures :
  1. GASE scale questionnaire (generic assessment of side effects) [ Time Frame: 1 week ]
    Patients who reported a history of poor corticosteroid tolerability will be placed on Acthar and GASE scale will be given to assess tolerability to Acthar.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258217


Locations
United States, Ohio
OhioHealth
Columbus, Ohio, United States, 43214
Sponsors and Collaborators
OhioHealth
Investigators
Principal Investigator: Aaron L Boster, MD OhioHealth

Responsible Party: Aaron Boster, MD, Riverside Methodist Hospital
ClinicalTrials.gov Identifier: NCT02258217     History of Changes
Other Study ID Numbers: 2014H0156
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs