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 he 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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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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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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Safety outcome Disease progression at week 96 on MRI-enterography Drug related serious adverse events Serious disease related adverse events (hospitalisation, surgery)
Secondary outcomes |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Newly diagnosed treatment naive CD patients or patients with an established diagnosis without medical treatment for > 1 year and naïve to biologicals or thiopurines visiting the outpatient clinic or endoscopy ward of the participating centres. • CD diagnosis according to ECCO-guidelines + complete ileo-colonoscopy + complete small bowel imaging at diagnosis (MRI or CT-enterography) • Sufficient knowledge Dutch language • 18 years old < 65 years old • No-contraindication for anti-TNF or immunosuppressant treatment. (Contra-indications are: a symptomatic stricture, an abscess, a history of tuberculosis or other granulomatous infection, a positive chest radiograph or Quantiferon or tuberculin skin test with purified protein derivative, a recent history of an opportunistic infection (within the previous 6 months), active infection with hepatitis B or C, infection with the human immunodeficiency virus, multiple sclerosis, cancer(except adequately treated non melanoma skin cancer), or a homozygous mutant or heterozygous thiopurine methyltransferase phenotype). • No contra-indication for MRI-enterography • Smartphone or tabloid with internet access
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• Newly diagnosed treatment naive CD patients or patients with an established diagnosis without medical treatment for > 1 year and naïve to biologicals or thiopurines visiting the outpatient clinic or endoscopy ward of the participating centres. • CD diagnosis according to ECCO-guidelines + complete ileo-colonoscopy + complete small bowel imaging at diagnosis (MRI or CT-enterography) • Sufficient knowledge Dutch language • 18 years old < 65 years old • No-contraindication for anti-TNF or immunosuppressant treatment. (Contra-indications are: a symptomatic stricture, an abscess, a history of tuberculosis or other granulomatous infection, a positive chest radiograph or Quantiferon or tuberculin skin test with purified protein derivative, a recent history of an opportunistic infection (within the previous 6 months), active infection with hepatitis B or C, infection with the human immunodeficiency virus, multiple sclerosis, cancer(except adequately treated non melanoma skin cancer), or a homozygous mutant or heterozygous thiopurine methyltransferase phenotype). • No contra-indication for MRI-enterography • Smartphone or tabloid with internet access
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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 • Perianal fistula at diagnosis • Sever disease requiring hospitalisation at diagnosis • Contra-indication for anti-TNF or immunosuppressive Patients with the short bowel syndrome or an ostomy |
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 • Perianal fistula at diagnosis • Sever disease requiring hospitalisation at diagnosis • Contra-indication for anti-TNF or immunosuppressive Patients with the short bowel syndrome or an ostomy |
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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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Kwartalen prednison vrije klinische en biochemische remissie op |
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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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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.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 | 5 |
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 | |