Clinical trial NCT02632175: Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
Official title: A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Ulcerative Colitis Who Completed the Study M11-290
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-12-16
Enrollment: 59
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Approximately 298 Weeks
measure: Proportion of subjects who achieve clinical remission as measured by PMS
timeFrame: Up through Week 288
measure: Proportion of subjects who achieve PUCAI response
timeFrame: Up through Week 288
measure: Proportion of subjects who achieve clinical response as measured by Partial Mayo Score (PMS)
timeFrame: Up through Week 288
measure: Proportion of subjects who achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) remission
timeFrame: Up through Week 288
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Arnold Palmer Hospital /ID# 147295
state: Florida
city: Minneapolis
country: United States
facility: MNGI Digestive Health, P. A. /ID# 147294
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 147304
state: Minnesota
city: Tacoma
country: United States
facility: MultiCare Institute Health System /ID# 169005
state: Washington
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 145710
state: Fukuoka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 147315
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center for Child Health and Development /ID# 147312
state: Tokyo
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 147310
state: Dolnoslaskie
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki /ID# 169017
state: Lodzkie
city: Krakow
country: Poland
facility: Uniwersytecki Szpital Dzieciecy w Krakowie /ID# 147279
state: Malopolskie
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM /ID# 147280
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Gabinet Lekarski Bartosz Korcz /ID# 147281
state: Podkarpackie
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin /ID# 147283
state: Zilinsky Kraj
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 147288
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 147290
state: Greater London
city: London
country: United Kingdom
facility: Duplicate_The Royal Free London NHS Foundation Trust /ID# 147292
state: Greater London
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: