Predictor of Clinical Response to Acthar in Myositis: Phase II of Acthar Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- IMACS Core Set Measures Improvement
Study Overview
Brief Summary
Comparing the clinical effects of Acthar Gel before and after treatment and compare it to patients with inactive disease.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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 Outcomes
- Myositis Response Criteria(6 Months)
Investigators
Rohit Aggarwal, MD
Associate Professor
University of Pittsburgh