Predictor of Clinical Response to Acthar in Myositis

Dermatomyositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414086
• Other study ID #: PRO16100125
• Status: Completed
• Start date: November 6, 2017
• Est. completion date: July 30, 2022

Study information

• Verified date: August 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatomyositis
• Myositis
• Polymyositis

Intervention

Other:
• Healthy Control
Ten healthy adult patients evaluating serum, PBMC's, and RNA.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IMACS Core Set Measures Improvement	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	Myositis Response Criteria	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