3562 CAPE Study Version 1.0
Research type
Research Study
Full title
A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of Humira® (Adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn's Disease (CD) – CAPE
IRAS ID
153352
Contact name
Daniel Kreeb
Contact email
Sponsor organisation
AbbVie Ltd
Clinicaltrials.gov Identifier
EU/1/03/256/001-010, Product Reference; EMA/540136/2009, ENCePP Steering Group Doc. Ref.; NCT02130362, Clintrials.gov
Duration of Study in the UK
16 years, 0 months, 1 days
Research summary
This study is taking place at a number of locations in various countries around the world. It will capture information regarding the routine care of paediatric patients (aged between 6 & 17 at the start of the study) who have moderate to severe active Crohn’s Disease. These patients will be receiving treatment with either Humira® or another immunosuppressant drug.
The study will review the long-term safety and effectiveness of Humira® over a ten year period. The study (registry) will only monitor the drugs as they are regularly used by your doctor. There will be no change to any treatment as a result of the study.
Approximately 800 paediatric patients around the world will be monitored while using Humira and approximately 500 paediatric patients will be monitored on other immunosuppressant drugs used to treat Crohn’s Disease.
As well as reviewing the safety and effectiveness of Humira®, the impact of any interruptions to treatment will also be assessed.
This registry study is part of a post-marketing commitment from AbbVie to the European Medicines Agency (EMA).
REC name
West of Scotland REC 5
REC reference
14/WS/1113
Date of REC Opinion
2 Oct 2014
REC opinion
Favourable Opinion