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Study · Randomized controlled trial · n = 259 · 2020

5 results

Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial.

Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R

Rheumatology and therapy17 Mar 2020Cited by 26 (Europe PMC)

PMID32185745 (opens in a new tab)PMCIDPMC7211215 (opens in a new tab)DOI10.1007/s40744-020-00199-3 (opens in a new tab)PepBankPUB-32185745
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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 RA induction responders, 47 RCI-treated subjects (61.0%) maintained low disease activity versus 32 (42.1%) with placebo at week 24 (p = 0.019).

    In plain wordsIn RA induction responders, RCI maintained low disease activity more often than placebo at week 24.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseMaintained low disease activity at week 24
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Disease activity · Immune and inflammation
    Studied dose
    80 U twice weekly · 12 weeksAs given in this study (human).

    Measurements

    Subjects maintaining low disease activity
    47 subjects
    RCI, week 24 (randomized withdrawal part 2)
    Subjects maintaining low disease activity
    61%
    RCI, week 24
    Subjects maintaining low disease activity
    32 subjects
    placebo, week 24
    Subjects maintaining low disease activity
    42.1%
    placebo, week 24
    P value
    0.019
    RCI versus placebo, maintained LDA at week 24

    Source sentences

    Summary
    At week 24, 47 (61.0%) RCI-treated and 32 (42.1%) placebo-treated subjects maintained LDA (p = 0.019); 66 (85.7%) RCI-treated and 50 (65.8%) placebo-treated subjects maintained CDAI ≤ 10 (p = 0.004).
    1 context sentence
    Summary · context
    only those with low disease activity [LDA; i.e., Disease Activity Score 28 joint count and erythrocyte sedimentation rate (DAS28-ESR) < 3.2] were randomly assigned to receive either RCI (80 U) or placebo twice weekly during the 12-week double-blind period (part 2).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In RA induction responders, 66 RCI-treated subjects (85.7%) maintained CDAI ≤ 10 versus 50 (65.8%) with placebo at week 24 (p = 0.004).

    In plain wordsIn RA induction responders, RCI maintained CDAI ≤ 10 more often than placebo at week 24.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseMaintained CDAI ≤ 10 at week 24
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Disease activity · Immune and inflammation
    Studied dose
    80 U twice weekly · 12 weeksAs given in this study (human).

    Measurements

    Subjects maintaining CDAI <= 10
    66 subjects
    RCI, week 24 (randomized withdrawal part 2)
    Subjects maintaining CDAI <= 10
    85.7%
    RCI, week 24
    Subjects maintaining CDAI <= 10
    50 subjects
    placebo, week 24
    Subjects maintaining CDAI <= 10
    65.8%
    placebo, week 24
    P value
    0.004
    RCI versus placebo, maintained CDAI <= 10 at week 24

    Source sentences

    Summary
    At week 24, 47 (61.0%) RCI-treated and 32 (42.1%) placebo-treated subjects maintained LDA (p = 0.019); 66 (85.7%) RCI-treated and 50 (65.8%) placebo-treated subjects maintained CDAI ≤ 10 (p = 0.004).
    1 context sentence
    Summary · context
    only those with low disease activity [LDA; i.e., Disease Activity Score 28 joint count and erythrocyte sedimentation rate (DAS28-ESR) < 3.2] were randomly assigned to receive either RCI (80 U) or placebo twice weekly during the 12-week double-blind period (part 2).
  3. 03HumanNon-randomized trialEfficacy outcome

    In active RA despite corticosteroid/DMARD therapy, 163 subjects (62.9%) achieved low disease activity at week 12 during RCI induction (p < 0.0001).

    In plain wordsIn active RA despite corticosteroid/DMARD therapy, 62.9% achieved low disease activity during RCI induction.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseLow disease activity at week 12
    Study

    n = 259

    Analysis
    Primary
    Outcome group
    Disease activity · Immune and inflammation
    Studied dose
    80 U twice weekly · 12 weeksAs given in this study (human).

    Measurements

    Subjects achieving low disease activity
    163 subjects
    week 12, open-label RCI part 1
    Subjects achieving low disease activity
    62.9%
    week 12, open-label RCI part 1
    P value
    < 0.0001
    low disease activity at week 12 (both p reported with CDAI result)

    Source sentences

    Summary
    At week 12, 163 subjects (62.9%) achieved LDA and 169 (65.3%) achieved CDAI ≤ 10 (both p < 0.0001).
    2 context sentences
    Summary · context
    The objective of this study was to assess efficacy and safety of repository corticotropin injection (RCI) in subjects with active rheumatoid arthritis (RA) despite treatment with a corticosteroid and one or two disease-modifying antirheumatic drugs (DMARDs).
    Summary · context
    All subjects received open-label RCI (80 U) twice weekly for 12 weeks (part 1)
  4. 04HumanNon-randomized trialEfficacy outcome

    In active RA despite corticosteroid/DMARD therapy, 169 subjects (65.3%) achieved CDAI ≤ 10 at week 12 during RCI induction (p < 0.0001).

    In plain wordsIn active RA despite corticosteroid/DMARD therapy, 65.3% achieved CDAI ≤ 10 during RCI induction.

    Peptide
    ACTH (corticotropin)
    Outcome
    IncreaseCDAI ≤ 10 at week 12
    Study

    n = 259

    Analysis
    Secondary
    Outcome group
    Disease activity · Immune and inflammation
    Studied dose
    80 U twice weekly · 12 weeksAs given in this study (human).

    Measurements

    Subjects achieving CDAI <= 10
    169 subjects
    week 12, open-label RCI part 1
    Subjects achieving CDAI <= 10
    65.3%
    week 12, open-label RCI part 1
    P value
    < 0.0001
    CDAI <= 10 at week 12 (both p reported with LDA result)

    Source sentences

    Summary
    At week 12, 163 subjects (62.9%) achieved LDA and 169 (65.3%) achieved CDAI ≤ 10 (both p < 0.0001).
    2 context sentences
    Summary · context
    The objective of this study was to assess efficacy and safety of repository corticotropin injection (RCI) in subjects with active rheumatoid arthritis (RA) despite treatment with a corticosteroid and one or two disease-modifying antirheumatic drugs (DMARDs).
    Summary · context
    All subjects received open-label RCI (80 U) twice weekly for 12 weeks (part 1)
  5. 05HumanNon-randomized trialSafety outcome

    In active RA, investigators observed no unexpected safety signals during the RCI study.

    In plain wordsIn active RA, investigators observed no unexpected safety signals during the RCI study.

    Peptide
    ACTH (corticotropin)
    Outcome
    Direction not reportedUnexpected safety signals
    Study

    n: not reported in source

    Outcome group
    Adverse events · Immune and inflammation
    Studied dose
    80 U twice weeklyAs given in this study (human).

    Source sentences

    Summary
    No unexpected safety signals were observed.
    1 context sentence
    Summary · context
    The objective of this study was to assess efficacy and safety of repository corticotropin injection (RCI) in subjects with active rheumatoid arthritis (RA) despite treatment with a corticosteroid and one or two disease-modifying antirheumatic drugs (DMARDs).

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 postedNCT02919761

Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

Mallinckrodtn = 2597 Nov 2016 to 13 Feb 2019

Arthritis, Rheumatoid

Trial pageClinicalTrials.govUpdated 31 Mar 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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