87
Participants
Start Date
March 15, 2020
Primary Completion Date
January 23, 2025
Study Completion Date
April 3, 2025
Adalimumab
Adalimumab is a fully human monoclonal anti-tumor necrosis factor alpha antibody, a biologic, immunomodulatory drug. Adalimumab 20mg/0.8 mL and 40mg/0.8 mL is a clear, colorless solution provided in a pre-filled syringe for subcutaneous injection. The formulation is adalimumab, mannitol, polysorbate 80, and water for injection Each pre-filled syringe has a fixed 29-gauge thin wall and ½ inch needle with black protective cover and is intended for a single dose to a single patient.
Placebo
The placebo solution is a clear, colorless solution provided in a single-use, pre-filled syringe for subcutaneous injection. The volume-matched (0.8mL) placebo is designed to match the characteristics of the citrate-free adalimumab during injection.
Murdoch Children's Research Institute, Parkville
Children's Hospital of Philadelphia, Philadelphia
University of Miami, Miami
Vanderbilt University Medical Center, Nashville
Cincinnati Children's Hospital, Cincinnati
Children's Mercy Hospital, Kansas City
University of Texas, Austin, Austin
University of Colorado Denver, Aurora
Colorado Retina Associates, Lakewood
University of Utah Health, Salt Lake City
University of California, San Francisco, San Francisco
University of California, Davis, Sacramento
University Hospitals Bristol and Weston, Bristol
Cambridge University Hospital, Cambridge
University Hospitals, Leicester, Leicester
Manchester University NHS Foundation Trust, Manchester
Alder Hey Children's Hospital, Liverpool
Great Ormond Street Hospital, London
Great North Children's Hospital, Newcastle upon Tyne
Norfolk and Norwich University Hospital, Norwich
Sheffield Children's Hospital, Sheffield
Children's Hospital of Philadelphia
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Children's Mercy Hospital Kansas City
OTHER
National Eye Institute (NEI)
NIH
Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
University Hospitals Bristol and Weston NHS Foundation Trust
OTHER
Alder Hey Children's NHS Foundation Trust
OTHER
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Sheffield Children's NHS Foundation Trust
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
Royal Children's Hospital
OTHER
Norfolk and Norwich University Hospitals NHS Foundation Trust
OTHER
Vanderbilt University Medical Center
OTHER
University of California, Davis
OTHER
University of Texas at Austin
OTHER
University of Miami
OTHER
University Hospitals, Leicester
OTHER
University of Utah
OTHER
Colorado Retina Associates
UNKNOWN
Manchester University NHS Foundation Trust
OTHER_GOV
Nisha Acharya
OTHER