Crohn’s disease
Conditions
Interventions
Product Name: humira
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
PIBDNet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Children 6-17, with a new-onset CD diagnosed using established criteria, only steroid-based or EN based induction therapies are allowed. • Luminal active CD (B1) with or without B2 and/or B3 disease behavior • Initial exposure to 5-ASA and derivate is tolerated • Exposure to antibiotics is tolerated • Informed and signed consent Are the trial subjects under 18? yes Number of subjects for this age range: 312 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous therapy with any IBD-related medications other than induction therapy as detailed in this protocol. • Pregnancy or refusal to use contraceptives during the study period in pubertal patients (both boys and girls) unless absolute abstinence (no sexual activity) is confirmed at each study visit. Positive pregnancy testing throughout the study will trigger prompt withdrawal of the patient from the study. • Children with perianal fistulising disease who require surgical therapy (drainage, seton placement) • Patients homozygous for TPMT (or very low TPMT activity (<6 nmol/h/ml erythrocytes or <9nmol 6MTG/g Hb/h), unless they qualify as high risk patients • Evidence of un-drained and un-controlled abscess/phlegmon • Patients with inactive disease at screening (i.e. disease diagnosis) defined by wPCDAI=12.5 and normal CRP and ESR. • Contraindication to any drugs used in the trial • Current or previous malignancy • Serious comorbidities interfering with drug therapy or interpretation of outcome parameters or will make it unlikely that the patients will finish the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effectiveness of weekly subcutaneously administered MTX for maintaining relapse-free sustained steroid/EN-free 1-year remission compared with: • daily oral AZA/6MP in low risk paediatric CD • subcutaneously administered adalimumab in high risk paediatric CD ;Secondary Objective: Comparison between the two treatment arms per risk group (high risk or low risk for aggressive disease evolution) (and inter-risk group analysis for MTX- treated patients) ;Primary end point(s): Comparing the two treatment arms per group for sustained steroid/EN-free remission at Month 12, where sustained remission is defined as wPCDAI =12.5 and CRP =1,5-fold upper limit without a relapse or need for EEN/steroids since week 12. ;Timepoint(s) of evaluation of this end point: At months 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparing the 2 treatment arms per risk group and comparing methotrexate treatment between high and low risk group;Timepoint(s) of evaluation of this end point: At months 12 | — |
Countries
Belgium, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, United Kingdom
Contacts
Public ContactSandrine ROUX
PIBDNet
Outcome results
None listed