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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Observational
Eligible Ages 6 Years - 17 Years
Gender All
More Inclusion & 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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03017014

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
AbbVie

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
AbbVie Inc.
Principal Investigator Affiliation AbbVie

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries France

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Crohn's Disease
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Rouen, France

Status

Recruiting

Address

Charles Nicolle Hosp chu rouen /ID# 158688

Rouen, , 76031

Rouen, France

Status

Not yet recruiting

Address

Charles Nicolle Hosp chu rouen /ID# 152670

Rouen, , 76031

CHU de Rennes - Hospital Sud /ID# 152730, Rennes, France

Status

Recruiting

Address

CHU de Rennes - Hospital Sud /ID# 152730

Rennes, , 35203

Chu Lyon Sud /Id# 152838, Pierre Benite, France

Status

Not yet recruiting

Address

Chu Lyon Sud /Id# 152838

Pierre Benite, , 69495

Necker Hopital, FR /ID# 152830, Paris, France

Status

Recruiting

Address

Necker Hopital, FR /ID# 152830

Paris, , 75743

Hopital Armand Trousseau /Id# 157092, Paris, France

Status

Not yet recruiting

Address

Hopital Armand Trousseau /Id# 157092

Paris, , 75571

Hopital Armand Trousseau /Id# 152669, Paris, France

Status

Not yet recruiting

Address

Hopital Armand Trousseau /Id# 152669

Paris, , 75571

Robert Debre Hopital, FR /ID# 152666, Paris, France

Status

Recruiting

Address

Robert Debre Hopital, FR /ID# 152666

Paris, , 75019

Hopital de la Source /ID# 165534, Orleans, France

Status

Not yet recruiting

Address

Hopital de la Source /ID# 165534

Orleans, , 45067

Hopital de la Source /ID# 159947, Orleans, France

Status

Not yet recruiting

Address

Hopital de la Source /ID# 159947

Orleans, , 45067

Hopital Jacques Monod /ID# 152663, Montivillier, France

Status

Not yet recruiting

Address

Hopital Jacques Monod /ID# 152663

Montivillier, , 76290

Hopital de la Timone /ID# 160133, Marseille, France

Status

Not yet recruiting

Address

Hopital de la Timone /ID# 160133

Marseille, , 13385

Hopital Jeanne de Flandre /Id# 155464, Lille, France

Status

Not yet recruiting

Address

Hopital Jeanne de Flandre /Id# 155464

Lille, , 59037

CHU Hopital d'Estaing /ID# 152664, Clermont Ferrand, France

Status

Recruiting

Address

CHU Hopital d'Estaing /ID# 152664

Clermont Ferrand, , 63100

Caen, France

Status

Recruiting

Address

Centre Hospitalier Universitai /ID# 155465

Caen, , 14033

Chu de Bordeaux Hopital /Id# 157926, Bordeaux, France

Status

Not yet recruiting

Address

Chu de Bordeaux Hopital /Id# 157926

Bordeaux, , 33076

Bordeaux, France

Status

Not yet recruiting

Address

CHU Bordeaux-Hopital Pellegrin /ID# 154620

Bordeaux, , 33076

CHU Batiment Robert Debre /ID# 152665, Angers, France

Status

Not yet recruiting

Address

CHU Batiment Robert Debre /ID# 152665

Angers, , 49933

CHU Toulouse /ID# 153251, Toulouse CEDEX 3, Occitanie, France

Status

Not yet recruiting

Address

CHU Toulouse /ID# 153251

Toulouse CEDEX 3, Occitanie, 31025

Hopitaux de Brabois Adultes /ID# 152729, Vandoeuvre les Nancy, Lorraine, France

Status

Recruiting

Address

Hopitaux de Brabois Adultes /ID# 152729

Vandoeuvre les Nancy, Lorraine, 54500

Besancon, Doubs, France

Status

Recruiting

Address

CHU de Besancon - Jean Minjoz /ID# 154197

Besancon, Doubs, 25000

Hopital Clocheville /ID# 152831, Tours, Centre-Val De Loire, France

Status

Not yet recruiting

Address

Hopital Clocheville /ID# 152831

Tours, Centre-Val De Loire, 37044

Centre Hospitalier Lyon Sud /ID# 152668, Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France

Status

Not yet recruiting

Address

Centre Hospitalier Lyon Sud /ID# 152668

Pierre Benite CEDEX, Auvergne-Rhone-Alpes, 69495

Centre Hospitalier Lyon Sud /ID# 152667, Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France

Status

Recruiting

Address

Centre Hospitalier Lyon Sud /ID# 152667

Pierre Benite CEDEX, Auvergne-Rhone-Alpes, 69495

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