Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE October 2, 2014
First Posted Date  ICMJE October 7, 2014
Last Update Posted Date September 12, 2017
Study Start Date  ICMJE June 2014
Actual Primary Completion Date June 24, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02258217 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)
Official Title  ICMJE Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Relapsing Remitting Multiple Sclerosis
Intervention  ICMJE Drug: Acthar
Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults.
Other Name: repository corticotropin
Study Arms  ICMJE Experimental: Single arm
Acthar 80 units subcutaneously for five consecutive days.
Intervention: Drug: Acthar
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date June 24, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02258217
Other Study ID Numbers  ICMJE 2014H0156
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aaron Boster, Riverside Methodist Hospital
Study Sponsor  ICMJE OhioHealth
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aaron L Boster, MD OhioHealth
PRS Account OhioHealth
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP