Control Crohn Safe Trial
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- STATUS
- Recruiting
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- End date
- Sep 30, 2024
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- participants needed
- 158
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- sponsor
- Maastricht University Medical Center
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 Identifier | NCT03917303 |
| Sponsor | Maastricht University Medical Center |
| Last Modified on | 30 May 2021 |
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