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Effects of ACTHAR on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS Relapses

NCT03021317 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-05-16

Study results available
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Summary

ACTHAR is a FDA approved drug for MS relapses. The purpose of the study is to examine the efficacy of this agent in improving relapses as measured by advanced MRI and laboratory techniques:

1. Advanced serial MRI studies on patients during and after an acute MS relapse. MRI will be performed at baseline, 1 month after the 1st dose of ACTHAR, and months 3, 6, and 12. ACTHAR will be administered for 10 days. Patients will start ACTHAR within 48 hours of relapse assessment.
2. Serial immune assays on patients during and after an acute MS relapse. Serum and blood samples with be collected at baseline, last day of ACTHAR (day 10 of therapy), 1 month post 1st dose, and months 3 and 6.

Conditions

Interventions

DRUG

ACTHar

The patients will be given 80 Units subcutaneously of ACTHAR at the time of MS relapse daily for 10 days.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Adil Javed, MD, PhD · University of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-20
Primary Completion
2020-10-07
Completion
2020-10-07

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03021317 on ClinicalTrials.gov