Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis

Completed · Phase 3

Conditions studied: Ulcerative Colitis

In brief

This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.

Key facts

Study ID

NCT02632175

Run by

AbbVie

People needed

59

Starts

2015-11-26

Expected to finish

2025-04-08

Last updated by the study team

2025-10-16

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must have successfully enrolled and completed M11-290 study

You may not qualify if…

• Subject considered by the investigator, for any reason, to be an unsuitable candidate

Where it is running

• Arnold Palmer Hospital /ID# 147295 — Orlando, Florida, United States
• MNGI Digestive Health, P. A. /ID# 147294 — Minneapolis, Minnesota, United States
• Mayo Clinic - Rochester /ID# 147304 — Rochester, Minnesota, United States
• MultiCare Institute Health System /ID# 169005 — Tacoma, Washington, United States
• Kurume University Hospital /ID# 145710 — Kurume-shi, Fukuoka, Japan
• Juntendo University Hospital /ID# 147315 — Bunkyo-ku, Tokyo, Japan
• National Center for Child Health and Development /ID# 147312 — Setagaya-ku, Tokyo, Japan
• Uniwersytecki Szpital Dzieciecy w Krakowie /ID# 147279 — Krakow, Lesser Poland Voivodeship, Poland
• Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 147310 — Wroclaw, Lower Silesian Voivodeship, Poland
• Centrum Zdrowia MDM /ID# 147280 — Warsaw, Masovian Voivodeship, Poland
• Gabinet Lekarski Bartosz Korcz /ID# 147281 — Rzeszów, Podkarpackie Voivodeship, Poland
• Instytut Centrum Zdrowia Matki Polki /ID# 169017 — Lodz, Łódź Voivodeship, Poland
• Univerzitna nemocnica Martin /ID# 147283 — Martin, Žilina Region, Slovakia
• Hospital Universitario Vall d'Hebron /ID# 147288 — Barcelona, Spain
• Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 147290 — London, Greater London, United Kingdom
• Duplicate_The Royal Free London NHS Foundation Trust /ID# 147292 — London, Greater London, United Kingdom

Full record on ClinicalTrials.gov

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