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Study · Non-randomized trial · 2021

6 results

Post Hoc Biomarker Analyses from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar® Gel) for Persistently Active Systemic Lupus Erythematosus.

Askanase AD, Wright D, Zhao E, Zhu J, Bilyk R, Furie RA

Rheumatology and therapy3 Sept 2021Cited by 5 (Europe PMC)

PMID34478124 (opens in a new tab)PMCIDPMC8572274 (opens in a new tab)DOI10.1007/s40744-021-00351-7 (opens in a new tab)PepBankPUB-34478124
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanNon-randomized trialMechanism

    In patients with active SLE, Acthar Gel reduced B cell-activating factor levels in all analyzed subgroups versus placebo.

    In plain wordsIn patients with active SLE, Acthar Gel reduced B cell-activating factor levels versus placebo in all analyzed subgroups.

    Peptide
    ACTH (corticotropin)
    Outcome
    DecreaseB cell-activating factor
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    80 U · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    RCI treatment resulted in reduced levels of B cell-activating factor and interleukin-6 cytokines in all subgroups compared with placebo.
    2 context sentences
    Summary · context
    We conducted post hoc analyses of biomarker results from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection (RCI; Acthar® Gel) in patients with persistently active systemic lupus erythematosus (SLE) despite treatment with moderate-dose glucocorticoids.
    Summary · context
    Patients were randomly assigned to 80 U of RCI or placebo subcutaneously every other day for 4 weeks and then twice weekly through week 24.
  2. 02HumanNon-randomized trialMechanism

    In patients with active SLE, Acthar Gel reduced interleukin-6 levels in all analyzed subgroups versus placebo.

    In plain wordsIn patients with active SLE, Acthar Gel reduced interleukin-6 levels versus placebo in all analyzed subgroups.

    Peptide
    ACTH (corticotropin)
    Outcome
    DecreaseInterleukin-6
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    80 U · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    RCI treatment resulted in reduced levels of B cell-activating factor and interleukin-6 cytokines in all subgroups compared with placebo.
    2 context sentences
    Summary · context
    We conducted post hoc analyses of biomarker results from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection (RCI; Acthar® Gel) in patients with persistently active systemic lupus erythematosus (SLE) despite treatment with moderate-dose glucocorticoids.
    Summary · context
    Patients were randomly assigned to 80 U of RCI or placebo subcutaneously every other day for 4 weeks and then twice weekly through week 24.
  3. 03HumanNon-randomized trialMechanism

    Acthar Gel lowered CD19-positive B cells versus placebo in SLE subgroups with higher baseline disease activity and in BICLA non-responders.

    In plain wordsActhar Gel lowered B cells versus placebo in SLE subgroups with higher baseline disease activity and in BICLA non-responders.

    Peptide
    ACTH (corticotropin)
    Outcome
    DecreaseCD19-positive B cells
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    80 U · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    RCI treatment also resulted in lower levels of CD19+ B cells and CD19+IgD-CD27-CD95+ atypical activated memory B cells than did placebo in the higher baseline disease activity subgroups and in BICLA non-responders.
    2 context sentences
    Summary · context
    We conducted post hoc analyses of biomarker results from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection (RCI; Acthar® Gel) in patients with persistently active systemic lupus erythematosus (SLE) despite treatment with moderate-dose glucocorticoids.
    Summary · context
    Patients were randomly assigned to 80 U of RCI or placebo subcutaneously every other day for 4 weeks and then twice weekly through week 24.
  4. 04HumanNon-randomized trialMechanism

    Acthar Gel lowered atypical activated memory B cells versus placebo in SLE subgroups with higher baseline disease activity and in BICLA non-responders.

    In plain wordsActhar Gel lowered atypical activated memory B cells versus placebo in SLE subgroups with higher disease activity and in BICLA non-responders.

    Peptide
    ACTH (corticotropin)
    Outcome
    DecreaseAtypical activated memory B cells
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    80 U · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    RCI treatment also resulted in lower levels of CD19+ B cells and CD19+IgD-CD27-CD95+ atypical activated memory B cells than did placebo in the higher baseline disease activity subgroups and in BICLA non-responders.
    2 context sentences
    Summary · context
    We conducted post hoc analyses of biomarker results from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection (RCI; Acthar® Gel) in patients with persistently active systemic lupus erythematosus (SLE) despite treatment with moderate-dose glucocorticoids.
    Summary · context
    Patients were randomly assigned to 80 U of RCI or placebo subcutaneously every other day for 4 weeks and then twice weekly through week 24.
  5. 05HumanNon-randomized trialMechanism

    Acthar Gel increased C3 more than placebo in SLE subgroups with higher baseline disease activity and in BICLA responders.

    In plain wordsActhar Gel increased C3 more than placebo in SLE subgroups with higher baseline disease activity and in BICLA responders.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseComplement C3
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    80 U · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Furthermore, RCI treatment led to greater increases in complement component (C)3 and C4 levels than did placebo in the higher baseline disease activity subgroups and in BICLA responders.
    2 context sentences
    Summary · context
    We conducted post hoc analyses of biomarker results from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection (RCI; Acthar® Gel) in patients with persistently active systemic lupus erythematosus (SLE) despite treatment with moderate-dose glucocorticoids.
    Summary · context
    Patients were randomly assigned to 80 U of RCI or placebo subcutaneously every other day for 4 weeks and then twice weekly through week 24.
  6. 06HumanNon-randomized trialMechanism

    Acthar Gel increased C4 more than placebo in SLE subgroups with higher baseline disease activity and in BICLA responders.

    In plain wordsActhar Gel increased C4 more than placebo in SLE subgroups with higher baseline disease activity and in BICLA responders.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseComplement C4
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    80 U · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Furthermore, RCI treatment led to greater increases in complement component (C)3 and C4 levels than did placebo in the higher baseline disease activity subgroups and in BICLA responders.
    2 context sentences
    Summary · context
    We conducted post hoc analyses of biomarker results from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection (RCI; Acthar® Gel) in patients with persistently active systemic lupus erythematosus (SLE) despite treatment with moderate-dose glucocorticoids.
    Summary · context
    Patients were randomly assigned to 80 U of RCI or placebo subcutaneously every other day for 4 weeks and then twice weekly through week 24.

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

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4Results postedNCT02953821

Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

Mallinckrodtn = 17216 Dec 2016 to 25 Oct 2019

Lupus Erythematosus, Systemic

Trial pageClinicalTrials.govUpdated 20 Aug 2020

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.

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