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

AbbVie62 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Crohn's Disease

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (24)

Centre Hospitalier Lyon Sud /ID# 152667

Pierre-Bénite, Auvergne-Rhône-Alpes, France

Outcomes

Primary Outcomes

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.

Time frame: Up to 12 years

Secondary Outcomes

Proportion of participants with dose escalation (dose and/or frequency of injections)

Dosing and/or frequency of injections is monitored to assess dose escalation.

Time frame: Up to 12 years

Median percent change from baseline in C-reactive protein (CRP)

The median percent change from baseline in CRP is assessed at each time point.

Time frame: From Month 0 to 12 years

Median percent change from baseline in calprotectin

The median percent change from baseline in calprotectin us assessed at each time point.

Time frame: From Month 0 to 12 years

Change from baseline in weighted Pediatric Crohn's Disease Activity Index (PCDAI)

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.

Time frame: From Month 0 to 12 years

Data from ClinicalTrials.gov

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Centre Hospitalier Lyon Sud /ID# 152668

Pierre-Bénite, Auvergne-Rhône-Alpes, France

Hopital Clocheville /ID# 152831

Tours, Centre-Val de Loire, France

CHU de Besancon - Jean Minjoz /ID# 154197

Besançon, Doubs, France

Hopitaux de Brabois Adultes /ID# 152729

Vandœuvre-lès-Nancy, Lorraine, France

CHU Toulouse /ID# 153251

Toulouse, Occitanie, France

CHU Batiment Robert Debre /ID# 152665

Angers, France

CHU Bordeaux-Hopital Pellegrin /ID# 154620

Bordeaux, France

Chu de Bordeaux Hopital /Id# 157926

Bordeaux, France

Centre Hospitalier Universitai /ID# 155465

Caen, France

...and 14 more locations

Change in wPCDAI >= 37.5

A change in wPCDAI \>= 37.5 indicates improvement.

Time frame: From Month 0 to 12 years

Incidence rate of CD-related hospitalizations

Hospitalization will be determined from the health care utilization information.

Time frame: Up to 12 years

Rate of clinical remission

Clinical remission is weighted PCDAI \< 12.5 or Harvey-Bradshaw index (HBI) \<5. Rate of clinical remission will be described at each time point

Time frame: Up to 12 years

Proportion of participants achieving mucosal healing at each time point

Mucosal healing is assessed using SES-CD score (0 or 1).

Time frame: Up to 12 years

Proportion of participants with steroid-free clinical remission at each time point

The proportion of participants with steroid-free clinical remission is assessed at each time point.

Time frame: Up to 12 years

Change in weight z-score

Growth is assessed by monitoring changes in weight z-score.

Time frame: From Month 0 to 12 years

Median percent change from baseline in high sensitivity C-reactive protein (hs-CRP)

The median percent change from baseline in hs-CRP is assessed at each time point.

Time frame: From Month 0 to 12 years

Assessing Mucosal healing

Mucosal healing is assessed using Simple Endoscopic Score for Cronh's Disease (SES-CD) score (0 or 1).

Time frame: Up to 12 years

Rate of steroid-free remission

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.

Time frame: Up to 12 years

Proportion of participants with fistula remission (in participants with fistulizing CD at entry)

Fistula remission is defined as closure for at least 2 consecutive visits of all fistulae that were draining at baseline

Time frame: Up to 12 years

Change in Tanner's staging

Tanner's staging is used to assess growth and pubertal development.

Time frame: From Month 0 to 12 years

Proportion of participants with immunomodulator-free clinical remission at each time point

The proportion of participants with immunomodulator-free clinical remission is assessed at each time point.

Time frame: Up to 12 years

Incidence rate of infectious events

The incidence rate of serious and non-serious opportunistic infections is assessed.

Time frame: Up to 12 years

Incidence rate of all-cause hospitalizations

Hospitalization will be determined from the health care utilization information.

Time frame: Up to 12 years

Proportion of participants with steroid tapering at each time point (steroids daily dosing lower than at baseline)

The proportion of participants with steroid tapering i.e., steroids daily dosing lower than at baseline (week 0) is assessed.

Time frame: Up to 12 years

Change in height z-score

Growth is assessed by monitoring changes in height z-score

Time frame: From Month 0 to 12 years

Proportion of participants with CD-related surgery

CD-related surgery includes subtotal colectomy with ileorectostomy, colectomy with ileo-anal pouch, Koch pouch, ileostomy, small bowel resection, and etc.

Time frame: Up to 12 years

Incidence rate of CD- or drug-related hospitalizations

Hospitalization will be determined from the health care utilization information.

Time frame: Up to 12 years