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

  • identifier


  • Recruitment Status


  • First Posted

    May 10, 2019

  • Last update posted

    May 13, 2020

Study Description

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.

  • Condition or Disease:Diabetes Mellitus, Type 1
  • Intervention/Treatment: Drug: Golimumab
  • Phase: N/A

Detailed Description


Study Design

  • Study Type: Expanded Access
  • Official Title: SIMPONI SC Managed Access Program
  • Study Start Date: N/A
  • Primary Completion Date: N/A
  • Study Completion Date: N/A

Outcome Measures

Eligibility Criteria

  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:


Inclusion Criteria:


Exclusion Criteria:


Contacts and Locations


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


United States, California
Rady Children's Hospital
San Diego

Sponsors and Collaborators

Janssen Research & Development, LLC


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

More Information

  • Responsible Party: Janssen Research & Development, LLC
  • Identifier: NCT03945903 History of Changes
  • Other Study ID Numbers: CR108621, CNTO148DML4001
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: May 13, 2020
  • Last Verified: May 2020
  • Additional relevant MeSH terms: Diabetes Mellitus Diabetes Mellitus, Type 1