Predictor of Clinical Response to Acthar in Myositis
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Infectious Disease, Orthopedic, Nephrology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Nephrology / Urology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/27/2018 |
| Start Date: | November 6, 2017 |
| End Date: | June 30, 2019 |
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.
patients with inactive disease.
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".
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".
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.
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University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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