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

Status

NO_LONGER_AVAILABLE

Phases

Unknown

Study type

Expanded Access

Source

ClinicalTrials.gov

Registry ID

NCT03945903

Enrollment

Unknown

Registered

2019-05-10

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 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.

Interventions

DRUGGolimumab

Participants will receive subcutaneous (SC) golimumab, where doses will be based on weight and/or body surface area.

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

Conditions

Brief summary

Interventions

Sponsors

Eligibility

Inclusion criteria

Exclusion criteria

Countries

Outcome results

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

Conditions

Brief summary

Related papers

Interventions

Sponsors

Eligibility

Inclusion criteria

Exclusion criteria

Countries

Outcome results