AI Article Synopsis
- Crohn's disease is a chronic condition with variable symptoms and treatment effectiveness, requiring careful management to avoid overtreatment, particularly in mild cases.
- A clinical trial will compare the effects of episodic treatment with the drug adalimumab against standard care starting with corticosteroids in newly diagnosed or flaring Crohn's disease patients, assessing various health outcomes over 96 weeks.
- The study aims to establish the benefits and safety of adalimumab while minimizing corticosteroid use and associated side effects, with ethical approval already granted for the research.
Article Abstract
Introduction: Crohn's disease (CD) is a chronic inflammatory bowel disease with a heterogeneous clinical presentation, relapse rate and treatment response. At present, no markers are available to adequately predict disease course at diagnosis. To prevent overtreatment of patients with a relative mild disease course, a step-up approach starting with corticosteroids is usually applied. Timely introduction of potentially disease modifying drugs and tight control of mucosal inflammation are crucial to prevent disease-related complications in patients with a complex disease course. We hypothesise that episodic treatment with adalimumab monotherapy in combination with close monitoring after drug discontinuation improves long-term outcome and reduces drug-related side effects, while preventing overtreatment.
Methods And Analysis: In this pragmatic multicentre randomised controlled trial, newly diagnosed CD patients or CD patients with a flare, naïve to thiopurines and biologicals, will be included and randomised 1:1 to open-label episodic (ie, 24 weeks) adalimumab monotherapy or step-up care starting with corticosteroids. The primary outcome is the number of yearly quarters of corticosteroid free clinical (Monitor Inflammatory Bowel Disease At Home score ≤3) and biochemical (C reactive protein within normal range and faecal calprotectin ≤200 µg/g) remission at week 96. Secondary outcomes are total healthcare costs, cumulative corticosteroid dose, proportion of patients with endoscopic remission at week 24, corticosteroid-free clinical remission, time to remission and patient-reported outcome measures on quality of life, (work) disability and treatment adherence. Safety outcomes are drug-related and disease-related adverse events and disease progression on MRI-enterography at week 96.
Ethics And Dissemination: This study is approved by the Medical Research Ethics Committee of azM/UM in Maastricht dated 21 August 2019 (METC18-076) and is monitored by the Clinical Trial Centre Maastricht according to Good Clinical Practice guidelines. Written informed consent will be obtained from all patients. Study results will be published in international peer-reviewed medical journals.
Trial Registration Number: NCT03917303.
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8098960 | PMC |
| http://dx.doi.org/10.1136/bmjopen-2020-042885 | DOI Listing |
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