A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions

Study Identifier
P15-759
CT.gov Identifier
NCT03017014
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Other
Sign up for trial alerts

Results Available

Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Crohn's Disease (CD)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    6 - 17 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * With confirmed diagnosis of Crohn's disease * Adalimumab-naïve patient (a patient having received an anti-TNF other than adalimumab may enter the study) * Starting a treatment with adalimumab * Guardian capable of and willing to grant authorization for use/disclosure of data collected and patient able to comply with the requirements of the study protocol.
    Exclusion Criteria:
    * Participants with a history of treatment with adalimumab * Participants enrolled in a concomitant interventional clinical trial.

    Protocol Summary

    The primary objective of this study is to evaluate long-term effectiveness of adalimumab in pediatric participants starting a treatment for Crohn's disease in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach. Main secondary objectives are to describe growth and pubertal development and to describe long-term safety. The participants will be followed-up up to 10 years.

    Study Locations

    Location
    Status
    Location
    Centre Hospitalier Lyon Sud /ID# 152667
    Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
    Status
    Not applicable
    Location
    Centre Hospitalier Lyon Sud /ID# 152668
    Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
    Status
    Not applicable
    Location
    Hopital Clocheville /ID# 152831
    Tours, Centre-Val De Loire, France, 37044
    Status
    Not applicable
    Location
    CHU de Besancon - Jean Minjoz /ID# 154197
    Besançon, Doubs, France, 25000
    Status
    Not applicable
    Location
    Hopitaux de Brabois Adultes /ID# 152729
    Vandœuvre-lès-Nancy, Lorraine, France, 54500
    Status
    Not applicable
    Location
    CHU Toulouse /ID# 153251
    Toulouse, Occitanie, France, 31025
    Status
    Not applicable
    Showing {first} - {last} of {total} Results