Pre-Approval Access to Golimumab Subcutaneous for the Treatment of Stage 3 Type-1 Diabetes Mellitus in Children and Young Adults
SIMPONI SC Managed Access Program
2 other identifiers
expanded_access
N/A
1 country
1
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.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2019
CompletedFirst Posted
Study publicly available on registry
May 10, 2019
CompletedApril 13, 2023
April 1, 2023
April 24, 2019
April 11, 2023
Conditions
Interventions
Participants will receive subcutaneous (SC) golimumab, where doses will be based on weight and/or body surface area.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rady Children's Hospital
San Diego, California, 92123, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2019
First Posted
May 10, 2019
Last Updated
April 13, 2023
Record last verified: 2023-04