Status:
UNKNOWN
Efficacy and Mechanism of Action of SCIg in Patients With Stiff Person Syndrome (SPS)
Lead Sponsor:
Thomas Jefferson University
Conditions:
Stiff-Person Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
This is a pilot, proof-of concept investigator-initiated trial planned for 22 patients with the diagnosis of Stiff Person Syndrome (SPS). The study will compare efficacy of treatment using subcutaneou...
Detailed Description
Study Design:This is a proof of concept observational prospective, open label, study on the safety, efficacy and convenience of treatment with SCIg study of 22 patients at Thomas Jefferson University ...
Eligibility Criteria
Inclusion
- Men or women aged \>18 years
- Diagnosis of SPS based on standard criteria
- IVIg Group: Receiving the equivalent of 1-2 g/kg IVIg every 4 weeks with dependence\* on IVIg to maintain clinical response \*Dependence is clinically determined either by symptomatic worsening of condition at the end of the inter-dose interval or by worsening after dose reduction or discontinuation within the previous 3 months.
- IVIg-Naïve Group: Patients with symptomatic SPS and never treated with IVIg (IVIg-naïve group), poorly controlled with standard therapy
Exclusion
- 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 of immunomodulatory treatment other than IVIg in the past 3 months
- Participation in a trial of an investigational medicinal product in the past 12 weeks
- Presence of any medical condition, which in the opinion of the investigator might interfere with performance or interpretation of this study.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03829826
Start Date
June 1 2019
End Date
May 1 2020
Last Update
May 14 2019
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