CoCroS trial

Prior treatment

• Indication for primary treatment with biologicals or surgery
• Contra-indication for TNF-blockers or immunosuppressive agents (Contraindications 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 or cancer (except adequately treated non melanoma skin cancer))

Other illness

• Patients with short bowel syndrome or an ostomy
• Malignancy in the 5 years before screening. Exception is adequately treated nonmelanoma skin cancer

Other

• Use of prednisone for longer than 4 weeks in the year before screening
• Use of thiopurines in the 3 years before screening
• Contra-indication for MRI- and CT-enterography
• Use of budesonide (≥6 mg daily) for a duration longer than 3 months in the year before screening

• 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 ileocolonoscopy (last endoscopy performed <12 months before screening) + complete small bowel imaging at diagnosis (MRI or CT-enterography)
• Naïve to biologicals
• 18 years old ≤ 70 years old
• Sufficient knowledge of Dutch language
• Smartphone with internet access
• Use of myIBDcoach or willingness to start using myIBDcoach