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.

Status
Available
EA Type
Individual Patients
Conditions
Diabetes Mellitus, Type 1
Interventions

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
All
Countries
United States
Locations

Rady Children's Hospital
San Diego, California, 92123

Available

Contacts

Study Contact
844-434-4210
Participate-In-This-Study@its.jnj.com

Investigators

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

Sponsors / Collaborators
Janssen Research & Development, LLC
NCT Number
NCT03945903
MeSH Terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Golimumab