Paediatric crohn's disease Digestive System Crohn's disease
Conditions
Interventions
At inclusion, patients were randomised per stratum, within each centre, using random permuted two to four sized-blocks (each centre did not know the size of their own block), to the following:
1. 50 m
Sponsors
Ferring SA (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children less than 18 years old, either sex 2. Diagnosed with crohn?s disease before the age of 16 by means of clinical, radiological, endoscopic and histological data 3. Had to be in an active phase defined by: 3.1. A Harvey Bradshaw score (HB) greater than or equal to 5, and 3.2. An erythrocyte sedimentation rate (ESR) greater than or equal to 25 mm at hour one 4. All lesion localisations, except exclusive anorectal localisation, were included, providing patients? lesion extension had been assessed within two years prior to inclusion After flare-up treatment, inclusion criteria were as follows: 1. Patients in clinical remission within six months following flare-up treatment initiation at pre-inclusion 2. An HB score under 5 3. An ESR under 25 mm 4. Normal hepatic and renal functions
Exclusion criteria
Exclusion criteria: 1. Flare-up had been treated with mesalazine or had required immuno-suppressors 2. Patients with known hypersensitivity to salicylate 3. Patients whose flare-up had occurred at pre-inclusion when on a 5-aminosalicylic acid (5-ASA) dose greater than 50 mg/kg/day for over two months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical relapse (HB score greater than or equal to 5, if confirmed within two weeks) 2. Surgery for an acute complication of CD Primary and secondary outcomes were measured either at one year of follow up with a medical visit every three months or when the primary or secondary outcomes occur during the one year follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment failure, defined as: 1. Relapse 2. Failure of steroid withdrawal (weaning failure) 3. Side-effects intolerance requiring treatment discontinuation 4. Worsening or aggravation of patient status requiring treatment interruption 5. Initiation of a new treatment as decided by the clinician Primary and secondary outcomes were measured either at one year of follow up with a medical visit every three months or when the primary or secondary outcomes occur during the one year follow up. | — |
Countries
France, Switzerland
Outcome results
None listed