Skip to content

Study · Randomized controlled trial · n = 35 · 2022

7 results

Results from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection for multiple sclerosis relapse that did not adequately respond to corticosteroids.

Wynn D, Goldstick L, Bauer W, Zhao E, Tarau E, Cohen JA, Robertson D, Miller A

CNS neuroscience & therapeutics4 Jan 2022Cited by 9 (Europe PMC)

PMID34984839 (opens in a new tab)PMCIDPMC8841301 (opens in a new tab)DOI10.1111/cns.13789 (opens in a new tab)PepBankPUB-34984839
Download PDFPubMedAsk about this study
Jump to 7 results

Summary

IntroductionAbout 20%-35% of multiple sclerosis (MS) patients fail to respond to high-dose corticosteroids during a relapse. Repository corticotropin injection (RCI, Acthar® Gel) is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and pituitary peptides that has anti-inflammatory and immunomodulatory effects.AimsThe study objective was to determine the efficacy and safety of RCI in patients with MS relapse that inadequately responded to corticosteroids. This was a multicenter, double-blind, placebo-controlled study. Nonresponders to high-dose corticosteroids were randomized to receive RCI (80 U) or placebo daily for 14 days. Assessments included improvements on the Expanded Disability Status Scale (EDSS), Multiple Sclerosis Impact Scale (MSIS-29), Clinical Global Impression of Improvement (CGI-I), and adverse events (AEs).ResultsEighteen patients received RCI, and 17 received placebo. A greater proportion of EDSS responders was observed in the RCI group at Day 7, 21, and 42 compared with the placebo group. Qualitative CGI-I showed that more patients receiving RCI were much improved or very much improved than with placebo. No meaningful differences were observed between treatment groups for MSIS-29. No serious AEs or deaths were reported.ConclusionRCI is safe and effective for MS relapse patients who do not respond to high-dose corticosteroids.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In corticosteroid-nonresponsive MS relapse, Acthar produced more EDSS responders than placebo at Day 7.

    In plain wordsIn MS relapse unresponsive to corticosteroids, more patients improved on EDSS with Acthar than placebo at Day 7.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseEDSS responders at Day 7
    Study

    n = 35

    Comparator
    Placebo
    Outcome group
    Disease activity · Nervous system and cognition
    Studied dose
    80 U daily · 14 daysAs given in this study (human).

    Source sentences

    Summary
    A greater proportion of EDSS responders was observed in the RCI group at Day 7, 21, and 42 compared with the placebo group.
    1 context sentence
    Summary · context
    Nonresponders to high-dose corticosteroids were randomized to receive RCI (80 U) or placebo daily for 14 days.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In corticosteroid-nonresponsive MS relapse, Acthar produced more EDSS responders than placebo at Day 21.

    In plain wordsIn MS relapse unresponsive to corticosteroids, more patients improved on EDSS with Acthar than placebo at Day 21.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseEDSS responders at Day 21
    Study

    n = 35

    Comparator
    Placebo
    Outcome group
    Disease activity · Nervous system and cognition
    Studied dose
    80 U daily · 14 daysAs given in this study (human).

    Source sentences

    Summary
    A greater proportion of EDSS responders was observed in the RCI group at Day 7, 21, and 42 compared with the placebo group.
    1 context sentence
    Summary · context
    Nonresponders to high-dose corticosteroids were randomized to receive RCI (80 U) or placebo daily for 14 days.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In corticosteroid-nonresponsive MS relapse, Acthar produced more EDSS responders than placebo at Day 42.

    In plain wordsIn MS relapse unresponsive to corticosteroids, more patients improved on EDSS with Acthar than placebo at Day 42.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseEDSS responders at Day 42
    Study

    n = 35

    Comparator
    Placebo
    Outcome group
    Disease activity · Nervous system and cognition
    Studied dose
    80 U daily · 14 daysAs given in this study (human).

    Source sentences

    Summary
    A greater proportion of EDSS responders was observed in the RCI group at Day 7, 21, and 42 compared with the placebo group.
    1 context sentence
    Summary · context
    Nonresponders to high-dose corticosteroids were randomized to receive RCI (80 U) or placebo daily for 14 days.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In corticosteroid-nonresponsive MS relapse, more Acthar recipients were much or very much improved on CGI-I than placebo recipients.

    In plain wordsIn MS relapse, more Acthar recipients were much or very much improved than placebo recipients.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseCGI-I much or very much improved
    Study

    n = 35

    Comparator
    Placebo
    Outcome group
    Disease activity · Nervous system and cognition
    Studied dose
    80 U daily · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Qualitative CGI-I showed that more patients receiving RCI were much improved or very much improved than with placebo.
    1 context sentence
    Summary · context
    Nonresponders to high-dose corticosteroids were randomized to receive RCI (80 U) or placebo daily for 14 days.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In corticosteroid-nonresponsive MS relapse, MSIS-29 did not differ meaningfully between Acthar and placebo.

    In plain wordsIn MS relapse, MSIS-29 results did not differ meaningfully between Acthar and placebo.

    Peptide
    ACTH (corticotropin)
    Outcome
    Direction not reportedMSIS-29
    Study

    n = 35

    Comparator
    Placebo
    Outcome group
    Disease activity · Nervous system and cognition
    Studied dose
    80 U daily · 14 daysAs given in this study (human).

    Source sentences

    Summary
    No meaningful differences were observed between treatment groups for MSIS-29.
    1 context sentence
    Summary · context
    Nonresponders to high-dose corticosteroids were randomized to receive RCI (80 U) or placebo daily for 14 days.
  6. 06HumanNon-randomized trialSafety outcome

    In corticosteroid-nonresponsive MS relapse, no serious adverse events were reported with Acthar.

    In plain wordsIn MS relapse, no serious adverse events were reported with Acthar.

    Peptide
    ACTH (corticotropin)
    Outcome
    Not applicableSerious adverse events
    Study

    n = 18

    Outcome group
    Adverse events · Whole body
    Studied dose
    80 U daily · 14 daysAs given in this study (human).

    Source sentences

    Summary
    No serious AEs or deaths were reported.
    1 context sentence
    Summary · context
    Nonresponders to high-dose corticosteroids were randomized to receive RCI (80 U) or placebo daily for 14 days.
  7. 07HumanNon-randomized trialSafety outcome

    In corticosteroid-nonresponsive MS relapse, no deaths were reported with Acthar.

    In plain wordsIn MS relapse, no deaths were reported with Acthar.

    Peptide
    ACTH (corticotropin)
    Outcome
    Not applicableDeaths
    Study

    n = 18

    Outcome group
    Mortality · Whole body
    Studied dose
    80 U daily · 14 daysAs given in this study (human).

    Source sentences

    Summary
    No serious AEs or deaths were reported.
    1 context sentence
    Summary · context
    Nonresponders to high-dose corticosteroids were randomized to receive RCI (80 U) or placebo daily for 14 days.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.