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Clinical Trial Details

Trial ID: L5337
Source ID: NCT03298542
Associated Drug: Golimumab
Title: A Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Pre-Symptomatic Type 1 Diabetes
Interventions: DRUG: Golimumab|DRUG: Placebo
Outcome Measures: Primary: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), Up to Week 26|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), Up to Week 52|Percentage of Participants With Treatment-Emergent Infections, Up to Week 26|Percentage of Participants With Treatment-Emergent Infections, Up to Week 52|Percentage of Participants With Study Treatment Injection Site Reactions, Up to Week 26|Number of Participants With Treatment Related AEs and SAEs Reported From Week 52 to Week 78, Week 52 to Week 78 | Secondary: Serum Concentration of Golimumab, Through Week 52|Incidence of Antibodies to Golimumab, Through Week 52
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE1
Enrollment: 8
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-10-16
Completion Date: 2021-06-01
Results First Posted:
Last Update Posted: 2025-02-03
Locations: UC Denver-Colorado Barbara Davis Center, University of Colorado SOM Pediatric Endocrinology, Aurora, Colorado, 80045, United States|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|University of Virginia, Charlottesville, Virginia, 22903, United States|Oulu University Hosp. Oulu, Oulu, FI-90014, Finland|Tampere University Hospital, Tampere, FI-33521, Finland|Turku University Hospital, Turku, 20520, Finland|Linkoping University Hospital, Linkoping, SE 58185, Sweden|Lund University Hospital/Skåne, Lund/Malmo, 205 02, Sweden
URL: https://clinicaltrials.gov/show/NCT03298542

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress