A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
- Conditions
- Crohn's Disease
- Registration Number
- NCT03017014
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 62
- 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.
- Participants with a history of treatment with adalimumab
- Participants enrolled in a concomitant interventional clinical trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to loss of clinical benefit Up to 12 years 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.
- Secondary Outcome Measures
Name Time Method Change in wPCDAI >= 37.5 From Month 0 to 12 years A change in wPCDAI \>= 37.5 indicates improvement.
Change in weight z-score From Month 0 to 12 years Growth is assessed by monitoring changes in weight z-score.
Incidence rate of CD-related hospitalizations Up to 12 years Hospitalization will be determined from the health care utilization information.
Assessing Mucosal healing Up to 12 years Mucosal healing is assessed using Simple Endoscopic Score for Cronh's Disease (SES-CD) score (0 or 1).
Proportion of participants with fistula remission (in participants with fistulizing CD at entry) Up to 12 years Fistula remission is defined as closure for at least 2 consecutive visits of all fistulae that were draining at baseline
Change in Tanner's staging From Month 0 to 12 years Tanner's staging is used to assess growth and pubertal development.
Proportion of participants with dose escalation (dose and/or frequency of injections) Up to 12 years Dosing and/or frequency of injections is monitored to assess dose escalation.
Median percent change from baseline in C-reactive protein (CRP) From Month 0 to 12 years The median percent change from baseline in CRP is assessed at each time point.
Rate of clinical remission Up to 12 years Clinical remission is weighted PCDAI \< 12.5 or Harvey-Bradshaw index (HBI) \<5. Rate of clinical remission will be described at each time point
Median percent change from baseline in calprotectin From Month 0 to 12 years The median percent change from baseline in calprotectin us assessed at each time point.
Change from baseline in weighted Pediatric Crohn's Disease Activity Index (PCDAI) From Month 0 to 12 years The Pediatric Activity Index (PCDAI) has become the standard outcome measure in pediatric Crohn's disease (CD) clinical research. The Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) was developed to add weight to the items in the PCDAI and make it more feasible. In the wPCDAI, growth velocity, abdominal examination, and hematocrit are removed. The wPCDAI score can range from 0-125, with higher signifying severe disease activity.
Proportion of participants achieving mucosal healing at each time point Up to 12 years Mucosal healing is assessed using SES-CD score (0 or 1).
Proportion of participants with steroid-free clinical remission at each time point Up to 12 years The proportion of participants with steroid-free clinical remission is assessed at each time point.
Rate of steroid-free remission Up to 12 years Steroid-free remission is defined as weighted PCDAI \< 12.5 or HBI \<5 and no daily intake of prednisone (whatever the route). Rate of steroid-free remission will be described at each time point.
Median percent change from baseline in high sensitivity C-reactive protein (hs-CRP) From Month 0 to 12 years The median percent change from baseline in hs-CRP is assessed at each time point.
Proportion of participants with immunomodulator-free clinical remission at each time point Up to 12 years The proportion of participants with immunomodulator-free clinical remission is assessed at each time point.
Incidence rate of infectious events Up to 12 years The incidence rate of serious and non-serious opportunistic infections is assessed.
Incidence rate of all-cause hospitalizations Up to 12 years Hospitalization will be determined from the health care utilization information.
Change in height z-score From Month 0 to 12 years Growth is assessed by monitoring changes in height z-score
Proportion of participants with CD-related surgery Up to 12 years CD-related surgery includes subtotal colectomy with ileorectostomy, colectomy with ileo-anal pouch, Koch pouch, ileostomy, small bowel resection, and etc.
Incidence rate of CD- or drug-related hospitalizations Up to 12 years Hospitalization will be determined from the health care utilization information.
Proportion of participants with steroid tapering at each time point (steroids daily dosing lower than at baseline) Up to 12 years The proportion of participants with steroid tapering i.e., steroids daily dosing lower than at baseline (week 0) is assessed.
Trial Locations
- Locations (24)
CHU Toulouse /ID# 153251
🇫🇷Toulouse CEDEX 3, Occitanie, France
CHU Bordeaux-Hopital Pellegrin /ID# 154620
🇫🇷Bordeaux, France
Chu de Bordeaux Hopital /Id# 157926
🇫🇷Bordeaux, France
Centre Hospitalier Universitai /ID# 155465
🇫🇷Caen, France
Hopital de la Timone /ID# 160133
🇫🇷Marseille, France
CHU de Besancon - Jean Minjoz /ID# 154197
🇫🇷Besancon, Doubs, France
CHU Batiment Robert Debre /ID# 152665
🇫🇷Angers, France
Hopital de la Source /ID# 159947
🇫🇷Orleans, France
Hopital Armand Trousseau /Id# 152669
🇫🇷Paris, France
Necker Hopital, FR /ID# 152830
🇫🇷Paris, France
Centre Hospitalier Lyon Sud /ID# 152668
🇫🇷Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France
CHU Hopital d'Estaing /ID# 152664
🇫🇷Clermont Ferrand, France
Hopital de la Source /ID# 165534
🇫🇷Orleans, France
CHU de Rennes - Hospital Sud /ID# 152730
🇫🇷Rennes, France
Charles Nicolle Hosp chu rouen /ID# 152670
🇫🇷Rouen, France
Charles Nicolle Hosp chu rouen /ID# 158688
🇫🇷Rouen, France
Hopital Jeanne de Flandre /Id# 155464
🇫🇷Lille, France
Robert Debre Hopital, FR /ID# 152666
🇫🇷Paris, France
Hopital Clocheville /ID# 152831
🇫🇷Tours, Centre-Val De Loire, France
Centre Hospitalier Lyon Sud /ID# 152667
🇫🇷Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France
Hopitaux de Brabois Adultes /ID# 152729
🇫🇷Vandoeuvre les Nancy, Lorraine, France
Chu Lyon Sud /Id# 152838
🇫🇷Pierre Benite, France
Hopital Armand Trousseau /Id# 157092
🇫🇷Paris, France
Hopital Jacques Monod /ID# 152663
🇫🇷Montivillier, France