Clinical trial NCT03017014: A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Official title: Assessing Long-term Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions-LEA
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Adalimumab
Humira®
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-01-11
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are children and adolescents with Crohn's disease

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.


Eligibility 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.

Primary outcomes:
measure: Time to loss of clinical benefit
timeFrame: Up to 12 years
Secondary outcomes:
measure: Proportion of participants with dose escalation (dose and/or frequency of injections)
timeFrame: Up to 12 years
measure: Median percent change from baseline in C-reactive protein (CRP)
timeFrame: From Month 0 to 12 years
measure: Median percent change from baseline in calprotectin
timeFrame: From Month 0 to 12 years
measure: Change from baseline in weighted Pediatric Crohn's Disease Activity Index (PCDAI)
timeFrame: From Month 0 to 12 years
measure: Change in wPCDAI >= 37.5
timeFrame: From Month 0 to 12 years
measure: Incidence rate of CD-related hospitalizations
timeFrame: Up to 12 years
measure: Rate of clinical remission
timeFrame: Up to 12 years
measure: Proportion of participants achieving mucosal healing at each time point
timeFrame: Up to 12 years
measure: Proportion of participants with steroid-free clinical remission at each time point
timeFrame: Up to 12 years
measure: Change in weight z-score
timeFrame: From Month 0 to 12 years
measure: Median percent change from baseline in high sensitivity C-reactive protein (hs-CRP)
timeFrame: From Month 0 to 12 years
measure: Assessing Mucosal healing
timeFrame: Up to 12 years
measure: Rate of steroid-free remission
timeFrame: Up to 12 years
measure: Proportion of participants with fistula remission (in participants with fistulizing CD at entry)
timeFrame: Up to 12 years
measure: Change in Tanner's staging
timeFrame: From Month 0 to 12 years
measure: Proportion of participants with immunomodulator-free clinical remission at each time point
timeFrame: Up to 12 years
measure: Incidence rate of infectious events
timeFrame: Up to 12 years
measure: Incidence rate of all-cause hospitalizations
timeFrame: Up to 12 years
measure: Proportion of participants with steroid tapering at each time point (steroids daily dosing lower than at baseline)
timeFrame: Up to 12 years
measure: Change in height z-score
timeFrame: From Month 0 to 12 years
measure: Proportion of participants with CD-related surgery
timeFrame: Up to 12 years
measure: Incidence rate of CD- or drug-related hospitalizations
timeFrame: Up to 12 years
Other outcomes:
Locations:
city: Pierre Benite CEDEX
country: France
facility: Centre Hospitalier Lyon Sud /ID# 152667
state: Auvergne-Rhone-Alpes
city: Pierre Benite CEDEX
country: France
facility: Centre Hospitalier Lyon Sud /ID# 152668
state: Auvergne-Rhone-Alpes
city: Tours
country: France
facility: Hopital Clocheville /ID# 152831
state: Centre-Val De Loire
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz /ID# 154197
state: Doubs
city: Vandoeuvre les Nancy
country: France
facility: Hopitaux de Brabois Adultes /ID# 152729
state: Lorraine
city: Toulouse CEDEX 3
country: France
facility: CHU Toulouse /ID# 153251
state: Occitanie
city: Angers
country: France
facility: CHU Batiment Robert Debre /ID# 152665
city: Bordeaux
country: France
facility: CHU Bordeaux-Hopital Pellegrin /ID# 154620
city: Bordeaux
country: France
facility: Chu de Bordeaux Hopital /Id# 157926
city: Caen
country: France
facility: Centre Hospitalier Universitai /ID# 155465
city: Clermont Ferrand
country: France
facility: CHU Hopital d'Estaing /ID# 152664
city: Lille
country: France
facility: Hopital Jeanne de Flandre /Id# 155464
city: Marseille
country: France
facility: Hopital de la Timone /ID# 160133
city: Montivillier
country: France
facility: Hopital Jacques Monod /ID# 152663
city: Orleans
country: France
facility: Hopital de la Source /ID# 159947
city: Orleans
country: France
facility: Hopital de la Source /ID# 165534
city: Paris
country: France
facility: Robert Debre Hopital, FR /ID# 152666
city: Paris
country: France
facility: Hopital Armand Trousseau /Id# 152669
city: Paris
country: France
facility: Hopital Armand Trousseau /Id# 157092
city: Paris
country: France
facility: Necker Hopital, FR /ID# 152830
city: Pierre Benite
country: France
facility: Chu Lyon Sud /Id# 152838
city: Rennes
country: France
facility: CHU de Rennes - Hospital Sud /ID# 152730
city: Rouen
country: France
facility: Charles Nicolle Hosp chu rouen /ID# 152670
city: Rouen
country: France
facility: Charles Nicolle Hosp chu rouen /ID# 158688
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: