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.

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
NCT Number
MeSH Terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Intervention Name