Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept Study
Dermatomyositis
About this trial
This is an interventional treatment trial for Dermatomyositis
Eligibility Criteria
Inclusion Criteria:
- Men or woman aged >18 years
- Diagnosis of DM based on standard criteria
- Receiving the equivalent of at least 0.4 g/kg IVIg every 4 weeks (IVIg group only)
- Established response to IVIg or dependence on IVIg to maintain status established either by symptomatic worsening of condition at the end of the inter-dose interval for both groups or by worsening after reduction of the dose within the previous 12 months (IVIg group only)
- IVIg regimen stable for 12 weeks while on IVIg (minor changes are permitted provided that the dose change is 15% or less) (IVIg group only)
- Stable dosing with steroids and/or other immunosuppressives for 12 weeks with no changes schedule or intended.
Exclusion Criteria:
- Pregnancy, planned pregnancy, breast feeding or unwillingness to practice contraception
- Severe concurrent medical conditions which would prevent treatment or assessment, including significant hematological, renal or liver dysfunction or malignancies
- Initiation or immunomodulatory treatment other than IVIg in the past 24 weeks or modification of immunomodulatory treatment other than IVIg in the past 12 weeks.
- Participation in trial of an investigational medicinal product in the past 12 weeks
- Presence of skin infection unrelated to dermatomyositis, severe skin involvement
Presence of any other medical condition, which in the opinion of the investigator might interfere with performance or interpretation of this study.
Sites / Locations
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
IVIg naive
non-IVIg naive
Patients naïve to IVIg who have active disease responding to corticosteroids or are corticosteroid-dependent, will be also included. Before these patients enter the study, they will receive 3 monthly infusions of IVIg starting with the standard dose of 2gram/kg/month and followed with monthly maintenance of 1 or 2gram/kg according to their response.
Participants already on IVIg will be observed for 12 weeks under their existing IVIg regimen and will undergo measurements of their muscle strength, skin changes, assessments of their daily activities and quality of life (QoL) every 4 weeks at scheduled visits for monthly maintenance IVIg infusions (weeks 0,4,8,12).