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Low enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric participants receiving adalimumab | Pediatric participants receiving adalimumab for CD in real-life conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to loss of clinical benefit | Loss of clinical benefit will be defined as one of the following:
| Up to 12 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with dose escalation (dose and/or frequency of injections) | Dosing and/or frequency of injections is monitored to assess dose escalation. | Up to 12 years |
| Median percent change from baseline in C-reactive protein (CRP) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants are children and adolescents with Crohn's disease
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Lyon Sud /ID# 152667 | Pierre-Bénite | Auvergne-Rhône-Alpes | 69495 | France | ||
| Centre Hospitalier Lyon Sud /ID# 152668 |
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| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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The median percent change from baseline in CRP is assessed at each time point.
| 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. | 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. | From Month 0 to 12 years |
| Change in wPCDAI >= 37.5 | A change in wPCDAI >= 37.5 indicates improvement. | From Month 0 to 12 years |
| Incidence rate of CD-related hospitalizations | Hospitalization will be determined from the health care utilization information. | 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 | 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). | 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. | Up to 12 years |
| Change in weight z-score | Growth is assessed by monitoring changes in weight z-score. | 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. | 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). | 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. | 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 | Up to 12 years |
| Change in Tanner's staging | Tanner's staging is used to assess growth and pubertal development. | 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. | Up to 12 years |
| Incidence rate of infectious events | The incidence rate of serious and non-serious opportunistic infections is assessed. | Up to 12 years |
| Incidence rate of all-cause hospitalizations | Hospitalization will be determined from the health care utilization information. | 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. | Up to 12 years |
| Change in height z-score | Growth is assessed by monitoring changes in height z-score | 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. | Up to 12 years |
| Incidence rate of CD- or drug-related hospitalizations | Hospitalization will be determined from the health care utilization information. | Up to 12 years |
| 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 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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