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

NCT ID: NCT03945903

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Interventions

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Golimumab

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

Intervention Type DRUG

Other Intervention Names

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SIMPONI

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Rady Children's Hospital

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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CNTO148DML4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108621

Identifier Type: -

Identifier Source: org_study_id

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