Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept Study
| Status: | Terminated |
|---|---|
| Conditions: | Skin and Soft Tissue Infections |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/18/2018 |
| Start Date: | November 2014 |
| End Date: | March 2, 2017 |
The purpose of the study is to evaluate the effectiveness and safety of human immunoglobulin
SCIg in the form of Hizentra (Immune globulin Subcutaneous) in patients with Dermatomyositis.
Hizentra provides effective protection against infection by maintaining a steady and normal
level of immunoglobulin in the body) in patients with primary immunodeficiency. At present,
patients with steroid resistant dermatomyositis can only be treated with IVIg (The healthy
antibodies in IVIG can block the damaging antibodies that attack muscle and skin in
dermatomyositis) treatment. An evaluation can then be made to see if SCIg is a suitable
replacement and exerts immunomodulatory effect on complement antibodies.
SCIg in the form of Hizentra (Immune globulin Subcutaneous) in patients with Dermatomyositis.
Hizentra provides effective protection against infection by maintaining a steady and normal
level of immunoglobulin in the body) in patients with primary immunodeficiency. At present,
patients with steroid resistant dermatomyositis can only be treated with IVIg (The healthy
antibodies in IVIG can block the damaging antibodies that attack muscle and skin in
dermatomyositis) treatment. An evaluation can then be made to see if SCIg is a suitable
replacement and exerts immunomodulatory effect on complement antibodies.
Inclusion Criteria:
1. Men or woman aged >18 years
2. Diagnosis of DM based on standard criteria
3. Receiving the equivalent of at least 0.4 g/kg IVIg every 4 weeks (IVIg group only)
4. 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)
5. 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)
6. Stable dosing with steroids and/or other immunosuppressives for 12 weeks with no
changes schedule or intended.
Exclusion Criteria:
1. Pregnancy, planned pregnancy, breast feeding or unwillingness to practice
contraception
2. Severe concurrent medical conditions which would prevent treatment or assessment,
including significant hematological, renal or liver dysfunction or malignancies
3. 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.
4. Participation in trial of an investigational medicinal product in the past 12 weeks
5. 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.
We found this trial at
1
site
1020 Walnut St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-7865
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