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

NCT03021317 | Terminated Phase 4 Results

• 1 other identifier: IRB16-1390
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in T1 Lesion Relaxation Time

  T1 relaxation time is a MRI marker of injury. The change in this metric will be followed over 12 months to see if lesions recover post ACTHAR intervention.

  12 month after the completion of intervention

Secondary Outcomes (1)

• Change in Immune Subset Expression in CD4+FOXP3 Tregs by Flow Cytometry Post ACTHAR Intervention

  6 month after the completion of intervention

Study Arms (1)

Treated Group

EXPERIMENTAL

Open label, single arm treatment study using MRI and laboratory markers to assess efficacy of ACTHAR in MS patients who are undergoing relapses.

Drug: ACTHar

Interventions

ACTHar DRUG

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

Also known as: repository corticotropin injection

Treated Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18
• undergoing a clinical relapse and associated MRI active lesion

You may not qualify if:

• Recent infection, any
• use of any glucocorticoid 30 days prior to enrollment
• unable to consent

Sponsors & Collaborators

• University of Chicago: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Sr. Compliance Specialist
• Organization: University of Chicago

czwieg@bsd.uchicago.edu

773-702-6505

Study Officials

• Adil Javed, MD, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 13, 2017
• Study Start: December 20, 2016
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share