Pre-Approval Access to Golimumab Subcutaneous for the Treatment of Stage 3 Type-1 Diabetes Mellitus in Children and Young Adults
- Conditions
- Diabetes Mellitus, Type 1
- Registration Number
- NCT03945903
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
This is a Single Patient Investigational New Drug (IND) to golimumab subcutaneous (SC) for the treatment of recently diagnosed Stage 3 type-1 diabetes mellitus (T1D) in children and young adults. The main purpose of a single patient IND is to provide treatment to participants with serious/life-threatening diseases or conditions prior to marketing authorization.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Exclusion Criteria
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rady Children's Hospital
🇺🇸San Diego, California, United States
Rady Children's Hospital🇺🇸San Diego, California, United States