Adalimumab for Pediatric Ulcerative Colitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
This trial is for children with ulcerative colitis who have finished the M11-290 study. It's not open to those whom the investigator thinks shouldn't participate for any reason.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Adalimumab for up to 288 weeks to assess long-term safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may continue to receive Adalimumab beyond the initial treatment period
What Are the Treatments Tested in This Trial?
Interventions
- Adalimumab
Adalimumab is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois