Study Stopped
Low enrollment
A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
LEA
Assessing Long-term Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions-LEA
1 other identifier
observational
62
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2017
Typical duration for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2017
CompletedFirst Posted
Study publicly available on registry
January 11, 2017
CompletedStudy Start
First participant enrolled
September 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2019
CompletedOctober 8, 2020
October 1, 2020
2 years
January 9, 2017
October 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to loss of clinical benefit
Loss of clinical benefit will be defined as one of the following: * Loss of efficacy leading to adalimumab discontinuation or * Introduction / reinforcement of other immunosuppressants (ratio dose/weight) or * Introduction / reinforcement of corticosteroids (ratio dose/weight; reinforcement of corticosteroids are allowed within the 4 first months after start of adalimumab) * Introduction of enteral nutrition * CD-related surgery, discontinuation of adalimumab due to adverse event, death.
Up to 12 years
Secondary Outcomes (22)
Proportion of participants with dose escalation (dose and/or frequency of injections)
Up to 12 years
Median percent change from baseline in C-reactive protein (CRP)
From Month 0 to 12 years
Median percent change from baseline in calprotectin
From Month 0 to 12 years
Change from baseline in weighted Pediatric Crohn's Disease Activity Index (PCDAI)
From Month 0 to 12 years
Change in wPCDAI >= 37.5
From Month 0 to 12 years
- +17 more secondary outcomes
Study Arms (1)
Pediatric participants receiving adalimumab
Pediatric participants receiving adalimumab for CD in real-life conditions.
Eligibility Criteria
Participants are children and adolescents with Crohn's disease
You may qualify if:
- 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.
You may not qualify if:
- Participants with a history of treatment with adalimumab
- Participants enrolled in a concomitant interventional clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (24)
Centre Hospitalier Lyon Sud /ID# 152667
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
Centre Hospitalier Lyon Sud /ID# 152668
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
Hopital Clocheville /ID# 152831
Tours, Centre-Val de Loire, 37044, France
CHU de Besancon - Jean Minjoz /ID# 154197
Besançon, Doubs, 25000, France
Hopitaux de Brabois Adultes /ID# 152729
Vandœuvre-lès-Nancy, Lorraine, 54500, France
CHU Toulouse /ID# 153251
Toulouse, Occitanie, 31025, France
CHU Batiment Robert Debre /ID# 152665
Angers, 49933, France
CHU Bordeaux-Hopital Pellegrin /ID# 154620
Bordeaux, 33076, France
Chu de Bordeaux Hopital /Id# 157926
Bordeaux, 33076, France
Centre Hospitalier Universitai /ID# 155465
Caen, 14033, France
CHU Hopital d'Estaing /ID# 152664
Clermont-Ferrand, 63100, France
Hopital Jeanne de Flandre /Id# 155464
Lille, 59037, France
Hopital de la Timone /ID# 160133
Marseille, 13385, France
Hopital Jacques Monod /ID# 152663
Montivillier, 76290, France
Hopital de la Source /ID# 159947
Orléans, 45067, France
Hopital de la Source /ID# 165534
Orléans, 45067, France
Robert Debre Hopital, FR /ID# 152666
Paris, 75019, France
Hopital Armand Trousseau /Id# 152669
Paris, 75571, France
Hopital Armand Trousseau /Id# 157092
Paris, 75571, France
Necker Hopital, FR /ID# 152830
Paris, 75743, France
Chu Lyon Sud /Id# 152838
Pierre-Bénite, 69495, France
CHU de Rennes - Hospital Sud /ID# 152730
Rennes, 35203, France
Charles Nicolle Hosp chu rouen /ID# 152670
Rouen, 76031, France
Charles Nicolle Hosp chu rouen /ID# 158688
Rouen, 76031, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2017
First Posted
January 11, 2017
Study Start
September 26, 2017
Primary Completion
October 14, 2019
Study Completion
October 14, 2019
Last Updated
October 8, 2020
Record last verified: 2020-10