Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
- Registration Number
- NCT02632175
- Lead Sponsor
- AbbVie
- Brief Summary
This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- Subject must have successfully enrolled and completed M11-290 study
- Subject considered by the investigator, for any reason, to be an unsuitable candidate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Subjects receiving Adalimumab Adalimumab Subjects receiving Adalimumab up to 288 weeks
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) Up to Approximately 298 Weeks An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Proportion of subjects who achieve clinical response as measured by Partial Mayo Score (PMS) Up through Week 288 Clinical response is defined as a decrease in PMS equal to or greater than 2 points and equal to or greater than 30% from Study M11-290 Baseline
Proportion of subjects who achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) remission Up through Week 288 PUCAI remission is defined as a score less than 10.
Proportion of subjects who achieve clinical remission as measured by PMS Up through Week 288 Clinical remission is defined as a PMS less than or equal to 2 and no individual sub score greater 1
Proportion of subjects who achieve PUCAI response Up through Week 288 PUCAI response is defined as a decrease in PUCAI greater than or equal to Up to 20 points from Study M11-290 Baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
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 Kliniczny im. Jana Mikulicza-Radeckiego /ID# 147310
🇵🇱Wroclaw, Dolnoslaskie, Poland
Instytut Centrum Zdrowia Matki Polki /ID# 169017
🇵🇱Lodz, Lodzkie, Poland
Uniwersytecki Szpital Dzieciecy w Krakowie /ID# 147279
🇵🇱Krakow, Malopolskie, Poland
Centrum Zdrowia MDM /ID# 147280
🇵🇱Warszawa, Mazowieckie, Poland
Gabinet Lekarski Bartosz Korcz /ID# 147281
🇵🇱Rzeszow, Podkarpackie, Poland
Univerzitna nemocnica Martin /ID# 147283
🇸🇰Martin, Zilinsky Kraj, Slovakia
Hospital Universitario Vall d'Hebron /ID# 147288
🇪🇸Barcelona, Spain
Barts Health NHS Trust /ID# 147290
🇬🇧London, Greater London, United Kingdom
Duplicate_The Royal Free London NHS Foundation Trust /ID# 147292
🇬🇧London, Greater London, United Kingdom