Trial Outcomes & Findings for Effects of ACTHAR on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS Relapses (NCT NCT03021317)
NCT ID: NCT03021317
Last Updated: 2024-05-16
Results Overview
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.
TERMINATED
PHASE4
5 participants
12 month after the completion of intervention
2024-05-16
Participant Flow
No participants started the trial and received the intervention.
Participant milestones
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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.
ACTHar: The patients will be given 80 Units subcutaneously of ACTHAR at the time of MS relapse daily for 10 days.
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Overall Study
STARTED
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0
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of ACTHAR on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS Relapses
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 12 month after the completion of interventionPopulation: No participants started the trial and received the intervention.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 month after the completion of interventionPopulation: No participants started the trial and received the intervention.
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.
Outcome measures
Outcome data not reported
Adverse Events
Treated Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place