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Study · Randomized controlled trial · 2021

5 results

Patient-Reported Outcomes 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, Wan GJ, Panaccio MP, Zhao E, Zhu J, Bilyk R, Furie RA

Rheumatology and therapy9 Mar 2021Cited by 10 (Europe PMC)

PMID33687687 (opens in a new tab)PMCIDPMC7991053 (opens in a new tab)DOI10.1007/s40744-021-00294-z (opens in a new tab)PepBankPUB-33687687
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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 study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In persistently active SLE, Acthar improved LupusQoL planning more than placebo at week 24.

    In plain wordsIn active lupus, Acthar improved planning-related quality of life more than placebo at week 24.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseLupusQoL planning at week 24
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Quality of life · Immune and inflammation
    Studied dose
    80 U every other day through week 4, then twice weekly through week 24 · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    RCI treatment resulted in greater improvement in the LupusQoL pain domain at week 16 and planning domain at week 24 compared with placebo.
    2 context sentences
    Summary · context
    We assessed patient-reported outcomes 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 through week 4, then twice weekly through week 24.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In persistently active SLE, Acthar improved LupusQoL pain more than placebo at week 16.

    In plain wordsIn active lupus, Acthar improved pain-related quality of life more than placebo at week 16.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseLupusQoL pain at week 16
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Pain · Immune and inflammation
    Studied dose
    80 U every other day through week 4, then twice weekly through week 24 · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    RCI treatment resulted in greater improvement in the LupusQoL pain domain at week 16 and planning domain at week 24 compared with placebo.
    2 context sentences
    Summary · context
    We assessed patient-reported outcomes 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 through week 4, then twice weekly through week 24.
  3. 03HumanNon-randomized trialEfficacy outcome

    In SLE subgroups with higher disease activity and/or BICLA response, Acthar improved pain, planning, and fatigue domains more than placebo.

    In plain wordsIn lupus subgroups with higher activity and/or BICLA response, Acthar improved pain, planning, and fatigue domains more than placebo.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreasePain, planning, and fatigue in post hoc subgroups
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Quality of life · Immune and inflammation
    Studied dose
    80 U every other day through week 4, then twice weekly through week 24 · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Post hoc analyses demonstrated greater improvements with RCI in the pain, planning, and fatigue domains than with placebo at multiple time points in patients with higher disease activity by baseline SLEDAI-2K ≥ 10, CLASI-Activity ≥ 11, and BILAG-2004 ≥ 20 and/or in BICLA responders.
    2 context sentences
    Summary · context
    We assessed patient-reported outcomes 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 through week 4, then twice weekly through week 24.
  4. 04HumanNon-randomized trialEfficacy outcome

    In SLE patients with baseline CLASI-Activity below 11, Acthar improved work time missed more than placebo at week 24.

    In plain wordsIn lupus patients with lower skin disease activity, Acthar improved missed work time more than placebo at week 24.

    Peptide
    ACTH (corticotropin)
    Outcome
    DecreasePercentage work time missed at week 24
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Work productivity · Immune and inflammation
    Studied dose
    80 U every other day through week 4, then twice weekly through week 24 · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Compared with placebo, RCI also resulted in greater improvements in percentage work time missed at week 24 in patients with baseline CLASI-Activity < 11 and in percentage impairment while working at week 16 in BICLA responders.
    2 context sentences
    Summary · context
    We assessed patient-reported outcomes 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 through week 4, then twice weekly through week 24.
  5. 05HumanNon-randomized trialEfficacy outcome

    In SLE BICLA responders, Acthar improved impairment while working more than placebo at week 16.

    In plain wordsIn lupus BICLA responders, Acthar improved impairment at work more than placebo at week 16.

    Peptide
    ACTH (corticotropin)
    Outcome
    DecreasePercentage impairment while working at week 16
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Work productivity · Immune and inflammation
    Studied dose
    80 U every other day through week 4, then twice weekly through week 24 · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Compared with placebo, RCI also resulted in greater improvements in percentage work time missed at week 24 in patients with baseline CLASI-Activity < 11 and in percentage impairment while working at week 16 in BICLA responders.
    2 context sentences
    Summary · context
    We assessed patient-reported outcomes 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 through week 4, 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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