N/A N=30 Other

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

Relapsing Remitting Multiple Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT02258217 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living) — 3.1; 4.9 score on a scale — p=0.003

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Acthar (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: OhioHealth
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living)	3.1; 4.9	0.003 sig
PRIMARY ARMS (Assessing Relapses in Multiple Sclerosis) RSH Scores (Return to Previous Health)	4.6; 4.4	0.99
PRIMARY ARMS (Assessing Relapses in Multiple Sclerosis) TCS Scores (Total Composite Scores)	14.3	—
PRIMARY ARMS (Assessing Relapses in Multiple Sclerosis) PCS Scores (Partial Composite Scores)	7.7; 9.2	0.03 sig
PRIMARY MSIS (Multiple Sclerosis Impact Scale) -29 Physical Score	58.5; 56	0.19
PRIMARY MSIS (Multiple Sclerosis Impact Scale) - 29 Psychological Score.	29.4; 26.3	0.01 sig
PRIMARY EDSS (Expanded Disability Status Scale) Scores.	3.5; 3.0	0.23
PRIMARY SAGE (Self-administered Gerocognitive Exam) Scores	21; 21	0.44
SECONDARY GASE Scale Questionnaire (Generic Assessment of Side Effects)	3; 1; 2; 1; 1; 4	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02258217). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.