Control Crohn Safe Trial
Crohn's disease (CD) is a chronic disease with a heterogeneous clinical presentation, relapse rate and treatment response. Insufficient control of mucosal inflammation results in irreversible bowel damage and complications and at present no markers are available to predict such a complicated disease course at diagnosis
| Condition(s) | Crohn Disease, Inflammatory Bowel Diseases |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | Crohn's disease (CD) is a chronic disease with a heterogeneous clinical presentation, relapse rate and treatment response. Insufficient control of mucosal inflammation results in irreversible bowel damage and complications and at present no markers are available to predict such a complicated disease course at diagnosis. Therefore, to prevent overtreatment of low risk patients, step-up treatment with subsequent introduction of corticosteroids, thiopurines maintenance and TNF-blockers if a previous category fails is standard care. Combination treatment with thiopurines and a TNF-blocker is more effective than monotherapy but associated with a higher risk for infectious complications. Landmark studies convincingly showed an improved long-term outcome if the TNF-blocker infliximab is introduce |
| Who can participate | Inclusion Criteria: * Newly diagnosed CD patients or CD patients with a flare, 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 ) * Naïve to biologicals * Sufficient knowledge of Dutch language * 18 years old ≤ 70 years old * Smartphone with internet access * Use of myIBDcoach or willingness to start using myIBDcoach Exclusion Criteria: * Use of prednisone for longer than 4 weeks in the year before screening * Use of budesonide (≥6 mg daily) for a duration longer than 3 months in the year before screening * Use of thiopurines in the 3 years before screening * Indication for primary treatment with biologicals or surgery * Ma |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Maastricht University Medical Center |
| Locations | Maastricht, Netherlands; Nieuwegein, Netherlands; Roermond, Netherlands; Sittard, Netherlands; Veldhoven, Netherlands; Venlo, Netherlands |
| Start date | 2019-12-23 |
| NCT ID | NCT03917303 |
| Official listing | https://clinicaltrials.gov/study/NCT03917303 |