Control Crohn Safe Trial

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    158
  • sponsor
    Maastricht University Medical Center
Updated on 30 May 2021
corticosteroids
combination therapy
monoclonal antibodies
chronic disease
endoscopy
adalimumab
infliximab
tumor necrosis factor
MRI
budesonide
crohn's disease
thiopurines
mucosal inflammation

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

Details
Condition Inflammatory Bowel Disease, Crohn's Disease (Pediatric), Intestinal Diseases, Crohn's Disease, inflammatory bowel diseases, Bowel Dysfunction, Gastroenteritis, crohns disease, Inflammatory bowel disease
Treatment Adalimumab, standard step-up care
Clinical Study IdentifierNCT03917303
SponsorMaastricht University Medical Center
Last Modified on30 May 2021

Eligibility

Yes No Not Sure

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 )
Nave to thiopurines and biologicals
Sufficient knowledge of Dutch language
years old 70 years old
Smartphone with internet access
Use of myIBDcoach or willingness to start using myIBDcoach

Exclusion Criteria

Malignancy in 5 years before treatment. Exception is adequately treated non-melanoma skin cancer
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
Severe disease requiring hospitalisation at screening
Contra-indication for TNF-blockers or immunosuppressive agents
Active perianal fistula at screening
Patients with short bowel syndrome or an ostomy
Contra-indication for MRI- and CT-enterography
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