Predictor of Clinical Response to Acthar in Myositis (NCT03414086) | Clinical Trial Compass
CompletedNot Applicable
Predictor of Clinical Response to Acthar in Myositis
United States20 participantsStarted 2017-11-06
Plain-language summary
Comparing the clinical effects of Acthar Gel before and after treatment and compare it to patients with inactive disease.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ca…