Clinical Trials Logo
  1. Home
  2. Diabetes Mellitus, Type 2
  3. NCT03945903
  4. Details
NCT03945903 Clinical Trial

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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
SIMPONI SC Managed Access Program

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT03945903
Other study ID # CR108621
Secondary ID CNTO148DML4001
Status No longer available
Phase
First received
Last updated

Study information
Verified date April 2023
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Rady Children's Hospital San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT03605329 - Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Recruiting NCT06050642 - Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop. N/A
Completed NCT05107544 - Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes N/A
Active, not recruiting NCT04443153 - Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes N/A
Completed NCT04569994 - A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes Phase 1
Completed NCT04521634 - Glycaemic Variability in Acute Stroke
Completed NCT04089462 - Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study N/A
Completed NCT03143816 - Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study Phase 4
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A
Completed NCT04042207 - Diabeloop for Highly Unstable Type 1 Diabetes N/A
Not yet recruiting NCT06068205 - COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
Recruiting NCT05909800 - Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes. Phase 2
Active, not recruiting NCT04974528 - Afrezza® INHALE-1 Study in Pediatrics Phase 3
Completed NCT04530292 - Home Intervention and Social Precariousness in Childhood Diabetes N/A
Completed NCT05428943 - OPT101 in Type 1 Diabetes Patients Phase 1
Recruiting NCT03988764 - Monogenic Diabetes Misdiagnosed as Type 1
Completed NCT05597605 - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects N/A