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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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

  • Clinicaltrials.gov identifier

    NCT03945903

  • Recruitment Status

    Available

  • 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

N/A

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:

Criteria

Inclusion Criteria:

-

Exclusion Criteria:

-

Contacts and Locations

Contacts

Contact: Study Contact 1-800-JANSSEN (1-800-526-7736) Janssenmedinfo@its.jnj.com

Locations

United States, California
Rady Children's Hospital
San Diego

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

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

More Information

  • Responsible Party: Janssen Research & Development, LLC
  • ClinicalTrials.gov 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