Predictor of Clinical Response to Acthar in Myositis

August 6, 2022 updated by: Rohit Aggarwal, MD, University of Pittsburgh

Predictor of Clinical Response to Acthar in Myositis: Phase II of Acthar Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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".

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Arthritis and Autoimmunity Center

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 6, 2017

Primary Completion (ACTUAL)

July 30, 2022

Study Completion (ACTUAL)

July 30, 2022

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (ACTUAL)

January 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 6, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO16100125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Outside researchers could obtain de-identified raw research data once approved from an ancillary committee.

IPD Sharing Time Frame

Data will not be made available until afte the primary manuscript is published. Data will be available indefinitely.

IPD Sharing Access Criteria

Approval from an ancillary committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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