At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 59 enrolled
Drug / intervention
Adalimumabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Adalimumab for Ulcerative Colitis. Completed, enrolled 59 participants across 16 sites in 6 countries.
Detailed Summary
This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesJapan, Poland, Slovakia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartNov 2015
First PostedDec 2015
Primary CompletionApr 2025
TodayJul 2026
First PostedDec 16, 2015
Enrollment StartNov 26, 2015
Primary CompletionApr 8, 2025
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 10.5 years ago
Interventions
Adalimumabbiological
every other week or weekly subcutaneous injection