Janssen Research & Development, LLC

Pre-Approval Access to Golimumab Subcutaneous for the Treatment of Stage 3 Type-1 Diabetes Mellitus in Children and Young Adults

Official Title: 
SIMPONI SC Managed Access Program
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.
EA Type
Individual Patients
Diabetes Mellitus, Type 1

Drug: Golimumab
Participants will receive subcutaneous (SC) golimumab, where doses will be based on weight and/or body surface area.
Other Name: SIMPONI

Eligibility Criteria: 

Inclusion Criteria:


Exclusion Criteria:


Eligibility Gender: 
United States

Rady Children's Hospital
San Diego, California, 92123



Study Contact
1-800-JANSSEN (1-800-526-7736

Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC

Janssen Research & Development, LLC
EA Number: 
MeSH Terms: 
Diabetes Mellitus, Diabetes Mellitus, Type 1, Antibodies, Monoclonal
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