E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The chronic inflammatory bowel disease Crohn's disease |
De chronische inflammatoire darmaandoening de ziekte van Crohn |
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E.1.1.1 | Medical condition in easily understood language |
Chronic inflammatory disease of the bowel Crohn's disease |
De chronische darmontsteking de ziekte van Crohn |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim of this study is to compare the long-term efficacy and safety of standard step-care with corticosteroid/budesonide as the initial treatment, with step-care with adalimumab as initial treatment for newly diagnosed CD patients. Primary outcome Quartiles of clinical and biochemical disease remission at week 96
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Het doel van deze studie is om de lange termijn effectiviteit en veiligheid van periodieke behandeling met adalimumab als initiële behandeling te vergelijken met de standaard step-care bij patiënten met (een nieuwe diagnose van) de ziekte van Crohn. |
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E.2.2 | Secondary objectives of the trial |
Safety outcome Disease progression at week 96 on MRI-enterography Drug related serious adverse events Serious disease related adverse events (hospitalisation, surgery)
Secondary outcomes Total health care costs at week 96 Cumulative corticosteroid dose at week 24, 48 and 96 Proportion of endoscopic remission at week w24 time to remission PROM: quality of life week 24, 48 and 96 PROM: (work) disability week 24, 48 and 96 PROM: tolerability of treatment week 24, 48 and 96
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Newly diagnosed CD patients or patients with a flare of an established diagnosis visiting the outpatient clinic or endoscopy ward of the participating centres. - naïve to biologicals or thiopurines - CD diagnosis according to ECCO-guidelines including complete ileo-colonoscopy + complete small bowel imaging at diagnosis (MRI or CT-enterography) - Sufficient knowledge Dutch language - 18 years old ≤ 70 years old - Smartphone with internet access - Use of myIBDcoach or willingness to start using myIBDcoach |
• Nieuw gediagnosticeerde CD-patiënten of patiënten met een opvlamming van een vastgestelde diagnose die de polikliniek of endoscopie-afdeling van de deelnemende centra bezoeken. - naïef voor biologicals of thiopurines • CD-diagnose volgens ECCO-richtlijnen inclusief volledige ileo-colonoscopie + volledige beeldvorming van de dunne darm bij diagnose (MRI of CT-enterografie) • Voldoende kennis van de Nederlandse taal • 18 jaar oud ≤ 70 jaar oud • Smartphone met internettoegang - gebruik van mijnIBDcoach |
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in this study: • Malignancy in 5 years before treatment. Exception adequate treated non-melanoma skin cancer • active perianal fistula at diagnosis • Sever disease requiring hospitalisation at diagnosis/inclusion • Contra-indication for anti-TNF or immunosuppressive - Patients with the short bowel syndrome or an ostomy - use of corticosteroids for a duration longer than 4 months in the year before screening - contra-indication for MRI- and CT-enterography |
• Maligniteit in 5 jaar vóór de behandeling. Uitzondering voldoende behandelde niet-melanoom huidkanker • Actieve perianale fistel bij diagnose • Ernstige ziekte waarvoor ziekenhuisopname nodig is bij diagnose • Contra-indicatie voor TNF-blokkers of immunosuppressiva •Contra-indicatie voor een MRI •Patiënten met het korte-darm syndroom of een stoma - gebruik van corticosteroïden gedurende meer dan 4 maanden in het jaar voor de screening - Contra-indicatie voor MRI-en CT-enterografie |
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E.5 End points |
E.5.1 | Primary end point(s) |
Quartiles of clinical and biochemical disease remission at week 96
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Het primaire eindpunt is het verschil in aantal kwartalen van corticosteroïd vrije klinische en biochemische remissie op week 96. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Safety outcome Disease progression at week 96 on MRI-enterography Drug related serious adverse events Serious disease related adverse events (hospitalisation, surgery)
Secondary outcomes Total health care costs at week 96 Cumulative corticosteroid dose at week 24, 48 and 96 Proportion of endoscopic remission at week w24 time to remission PROM: quality of life week 24, 48 and 96 PROM: (work) disability week 24, 48 and 96 PROM: tolerability of treatment week 24, 48 and 96
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De secundaire uitkomsten zijn de totale kosten voor gezondheidszorg, de cumulatieve dosis corticosteroïden, het deel van de patiënt met endoscopische remissie w24, geneesmiddelgerelateerde bijwerkingen en door de patiënt gerapporteerde uitkomstmaten voor de kwaliteit van leven, (arbeids) beperkingen en tolerantie van de behandeling. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standaard Step-up behandeling |
Standard Step-up treatment |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
Laatste visite van Laatste deelnemer |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |