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Trial record 59 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT03945903
Expanded Access Status : Available
First Posted : May 10, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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 Intervention/treatment
Diabetes Mellitus, Type 1 Drug: Golimumab

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: SIMPONI SC Managed Access Program

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Golimumab


Intervention Details:
  • Drug: Golimumab
    Participants will receive subcutaneous (SC) golimumab, where doses will be based on weight and/or body surface area.
    Other Name: SIMPONI

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Criteria

Inclusion Criteria:

-

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945903


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

Locations
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United States, California
Rady Children's Hospital
San Diego, California, United States, 92123
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03945903     History of Changes
Other Study ID Numbers: CR108621
CNTO148DML4001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases