Trial · Interventional

TerminatedPhase 4Results postedRegistry data

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

Short name ACTHAR

NCTNCT03021317Other idIRB16-1390

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Terminated early due to lack of resources.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 5 participants (actual)
Sponsor: University of Chicago · Other
Design: Allocation not applicable · Open label (no masking)
Countries: Not stated
Start: 20 Dec 2016
Primary completion: 7 Oct 2020
Completion: 7 Oct 2020
First posted: 13 Jan 2017 (estimated)
Last update posted: 16 May 2024
Conditions: Multiple Sclerosis

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201620172018201920202021

Ph 4
ACTHAR
NCT03021317
20 Dec 2016 to 7 Oct 2020
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

ACTHarDrug

Arms1

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in T1 Lesion Relaxation Time
Time frame · 12 month after the completion of intervention
Registry description
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.

Secondary outcomes(1)

Change in Immune Subset Expression in CD4+FOXP3 Tregs by Flow Cytometry Post ACTHAR Intervention
Time frame · 6 month after the completion of intervention
Registry description
Treg cells are unregulated during the healing process in MS relapses. Changes in this population of immune cells will be measured over a course of 6 months post ACTHAR intervention.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 12 month after the completion of intervention

Change in T1 Lesion Relaxation Time

Group	Value
Treated Group	not posted

Secondary and other outcome results(1)

Secondary outcome· 6 month after the completion of intervention

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

Group	Value
Treated Group	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Treated GroupOpen label, single arm treatment study using MRI and laboratory markers to assess efficacy of ACTHAR in MS patients who are undergoing relapses. ACTHar: The patients will be given 80 Units subcutaneously of ACTHAR at the time of MS relapse daily for 10 days.	0 / 0	0 / 0	0 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * age \> 18 * undergoing a clinical relapse and associated MRI active lesion Exclusion Criteria: * Recent infection, any * use of any glucocorticoid 30 days prior to enrollment * unable to consent

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