Control Crohn Safe Trial

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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 introduced early after diagnosis. The standard step-care approach thus prolongs steroid exposure and delays start of disease modifying biologicals in high risks patients. Given the higher efficacy of combination therapy with a thiopurine of infliximab and potential allergic reactions and lower response rates after re-initiation of this chimeric biological, temporary monotherapy with this TNF-blocker has not been studied as first line treatment before. Adalimumab is a humanised monoclonal antibody and subsequently, combination therapy of adalimumab + thiopurines has only a marginal effect on anti-drug anti-body formation. Furthermore, combination therapy with adalimumab does not enhance the clinical response. Therefore, periodic treatment with adalimumab in combination with close monitoring after drug-discontinuation, in newly diagnosed CD might improve outcome, reduce drug-related side effects while still preventing overtreatment.

The aim of this study is to compare the long-term efficacy and safety of periodic adalimumab as initial treatment in newly diagnosed CD patients compared to standard step-care with corticosteroid/budesonide as the initial treatment

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht University Medical Center
• Collaborators: Maastricht University; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Adalimumab

Criteria

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 thiopurines and 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 in the year before screening (excluding prednisone used as bridging before the start of study medication)

• Use of budesonide (≥6 mg daily) for a duration longer than 3 months in the year before screening

• Malignancy in 5 years before treatment. Exception is adequately treated non-melanoma skin cancer

• Active perianal fistula at screening

• Severe disease requiring hospitalisation at screening

• Contra-indication for TNF-blockers or immunosuppressive agents

• Contra-indication for MRI- and CT-enterography

• Patients with short bowel syndrome or an ostomy