A Phase 4 interventional study of Adalimumab and standard step-up care in Crohn Disease and Inflammatory Bowel Diseases, sponsored by Maastricht University Medical Center. Recruiting at 6 sites in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by Maastricht University Medical Center · Phase 4, Interventional, and Treatment
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
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 158 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Episodic adalimumab monotherapy as first line treatment for 6 months
Drug: Adalimumab
Step-up care as first line treatment, starting with corticosteroids.
Drug: standard step-up care
episodic treatment with subcutaneous adalimumab for 6 months
Also known as: Humira
conventional step-up care starting with corticosteroids
Number of yearly-quarters of corticosteroid free remission as a measure of treatment efficacy
Remission is defined as combined clinical (MIAH scores (≤3)) and biochemical (C-reactive protein ≤5 mg/L (i.e. within normal range) and fecal calprotectin ≤ 200 μg/g) remission.
Time frame: at week 96
Cumulative structural bowel damage as a measure of disease progression
Disease progression on MRI-enterography based on the Lémann score (Crohn's Disease Digestive Damage Score); the Lémann score is an instrument to measure cumulative structural bowel damage in Crohn's disease. The score takes into account the damage location (upper digestive tract, small bowel, colon/rectum and anal/perianal), extent and severity. Grades 0 (normal) to 3 (maximal) are given to each segment of the digestive tract, with grade 3 representing the most damage, or resection/bypass.
Time frame: at week 96
Incidence of drug related serious adverse events
Drug related serious adverse events
Time frame: at week 24, 48 and 96
Incidence of serious disease related adverse events
Crohn disease related hospitalisation and surgery
Time frame: at week 24, 48 and 96
Integer amount of direct health care costs (in €)
Direct costs include expenses for medication, diagnostic procedures, number of outpatient clinic visits, hospitalisations and surgeries. Direct costs will be combined with indirect costs to report total health care costs.
Time frame: at week 96
Integer amount of indirect health care costs (in €)
Indirect costs consist of costs due to presenteeism and absenteeism and are assessed by questionnaires in the telemedicine tool myIBDcoach used for monitoring of IBD patients. Indirect costs will be combined with direct costs to report total health care costs.
Time frame: at week 96
Corticosteroid use
Cumulative corticosteroid dose
Time frame: at week 24, 48 and 96
Endoscopic remission as assessed by SES-CD
Proportion of endoscopic remission based on SES-CD (simple endoscopic score for CD). Endoscopic remission is defined as a score below 3 and the absence of ulcers.
Time frame: at week 24
Time to remission
Time to remission
Time frame: at week 96
Quality of life as assessed by QoL EQ-5D-5L questionnaire
Quality of life as assessed by the QoL EQ-5D-5L questionnaire in which the level of severity is chosen for five domains (mobility, self-care, usual activities, pain, anxiety/depression). A higher level (maximal 5) indicates more severe problems in that particular domain.
Time frame: at week 24, 48 and 96
Plan to share: Yes — Data will be made available to other researchers on demand. Patients will be asked to give informed consent to share the collected data with third parties for future research.
Supporting information: Study protocol, Sap, Icf
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Maastricht University Medical Center