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Trial record 4 of 215 for:    Inflammatory Myopathies

Predictor of Clinical Response to Acthar in Myositis

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ClinicalTrials.gov Identifier: NCT03414086
Recruitment Status : Enrolling by invitation
First Posted : January 29, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Rohit Aggarwal, MD, University of Pittsburgh

Brief Summary:
Comparing the clinical effects of Acthar Gel before and after treatment and compare it to patients with inactive disease.

Condition or disease Intervention/treatment
Myositis Dermatomyositis Polymyositis Other: Healthy Control Other: Myositis in Remission

Detailed Description:
To compare the clinical impact of Acthar Gel at the cellular and molecular level before and after treatment and compare it to patients with inactive disease. The cohort of active myositis subjects are not actually enrolled in this study, but rather the data for those with active myositis will be obtained from a previously completed trial entitled "Efficacy and safety of Adenocorticotropic Hormone Gel in Refractory dermatomyositis and polymyositis".

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictor of Clinical Response to Acthar in Myositis: Phase II of Acthar Clinical Trial
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019


Group/Cohort Intervention/treatment
Myositis in Remission
Subjects who are in remission with their myositis diagnosis.
Other: Myositis in Remission
Ten patients (four who have polymyositis, six dermatomyositis) from our database who are followed in the Myositis Center. We will collect serum, PBMC's, and RNA samples will be obtained at baseline and at six months. Remission is defined as a global myositis disease activity score less than or equal to 1 on the MDAAT assessments with no new immunosuppressive drug or glucocorticoid use and no increase in dose of either in the preceding year.

Healthy Controls
Subjects who do not have a myositis diagnosis.
Other: Healthy Control
Ten healthy adult patients evaluating serum, PBMC's, and RNA.




Primary Outcome Measures :
  1. IMACS Core Set Measures Improvement [ Time Frame: 6 Months ]
    The International Myositis Assessment & Clinical Studies (IMACS) definition of improvement: Three of any of the six core set measures improved by greater than or equal to twenty percent, with no more than two core set measuring by greater than or equal to twenty five percent.


Secondary Outcome Measures :
  1. Myositis Response Criteria [ Time Frame: 6 Months ]
    This criteria yields a continuous improvement score which can be more readily extrapolated to individual response in subjects allowing correlation with baseline and longitudinal immunologic markers in these subjects.


Biospecimen Retention:   Samples Without DNA
We will be collecting serum, cells, and pax gene samples.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Arthritis and Autoimmunity Center
Criteria

Inclusion Criteria:

  • Healthy Controls:

    • An individual will be eligible to be a control subject if his/her age is 18 years or greater.
  • Myositis Remission Control Group

    • Definite or probable PM or DM by Bohan and Peter criteria.
    • PM patients must either possess a myositis-associated autoantibody or undergo adjudication for confirmation of the PM diagnosis by consensus of two experts (Aggarwal or Oddis) to ensure non-PM patients are not enrolled. This step is necessary since there are well known mimics of PM.
    • Age is greater than or equal to 18 years
    • Remission of myositis as defined by a myositis disease global activity score <1 on the MDAAT and no new immunosuppressive or glucocorticoid therapy or dose change within one year.

Exclusion Criteria:

  • Healthy Controls:

    • An existing diagnosis of a CTD
    • A potential immune compromised state, for example, treatment with immunosuppressant or anti-rejection medication or a diagnosis of an immune deficiency disease
  • Myositis Remission Control Group:

    • Juvenile DM or PM, myositis in overlap with another connective tissue disease, cancer associated myositis, inclusion body myositis, or any other non immune mediated myopathy.
    • Severe muscle damage defined as a baseline global muscle damage score on the MDI (Myositis Damage Index) of greater than or equal to five centimeters on a ten centimeter VAS.
    • Patients with malignancy within three years of screening (except basal cell cancer or squamous cell cancer of skin.
    • Uncontrolled diabetes, hepatic or renal disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414086


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Rohit Aggarwal, MD University of Pittsburgh

Publications:
rohit aggarwal cvo, andriy bandos, Danielle goudeau, diane koontz, qi zenbiao, ann m. reed. dan p ascherman, and marc c levesque. . effect of b cell depletion therapy with rituximab on myositis associated antibody levels in idiopathic inflammatory myopathy. arthritis and research. 2012;64(10(suppl.)):s325.
aggarwal r oc, bandos a, goudeau d, koontz d, zenbia q, reed am, ascherman dp, levesque mc. effect of b cell depletion therapy with rituximab on myositis associated antibody levels in idiopathic inflammatory myopathy. arthritis and research. 2012;64(10(suppl)):s325.
aggarwal r oc, Wilkerson er, koontz d, metes id, reed am, ascherman dp, levesque mc. peripheral blood memory b cell numbers predit clinical response following rituximab treatment of adult and childhood myositis. arthritis and research. 2013;65(10(suppl)):s755-66.
Rider LG, Werth VP, Huber AM, Alexanderson H, Rao AP, Ruperto N, Herbelin L, Barohn R, Isenberg D, Miller FW. Measures of adult and juvenile dermatomyositis, polymyositis, and inclusion body myositis: Physician and Patient/Parent Global Activity, Manual Muscle Testing (MMT), Health Assessment Questionnaire (HAQ)/Childhood Health Assessment Questionnaire (C-HAQ), Childhood Myositis Assessment Scale (CMAS), Myositis Disease Activity Assessment Tool (MDAAT), Disease Activity Score (DAS), Short Form 36 (SF-36), Child Health Questionnaire (CHQ), physician global damage, Myositis Damage Index (MDI), Quantitative Muscle Testing (QMT), Myositis Functional Index-2 (FI-2), Myositis Activities Profile (MAP), Inclusion Body Myositis Functional Rating Scale (IBMFRS), Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), Cutaneous Assessment Tool (CAT), Dermatomyositis Skin Severity Index (DSSI), Skindex, and Dermatology Life Quality Index (DLQI). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S118-57. doi: 10.1002/acr.20532. Review.

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Responsible Party: Rohit Aggarwal, MD, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03414086     History of Changes
Other Study ID Numbers: PRO16100125
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Outside researchers could obtain de-identified raw research data once approved from an ancillary committee.
Supporting Materials: Study Protocol
Time Frame: Data will not be made available until afte the primary manuscript is published. Data will be available indefinitely.
Access Criteria: Approval from an ancillary committee.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rohit Aggarwal, MD, University of Pittsburgh:
PM
DM

Additional relevant MeSH terms:
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Dermatomyositis
Myositis
Polymyositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases