engthening Adalimumab Dosing Interval in quiescent Crohn’s disease patients
Recruiting
- Registration Number
- NL-OMON21837
- Lead Sponsor
- Radboud university medical center, PO box 9101, 6500 HB Nijmegen Geert-Grooteplein Zuid 10
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 174
Inclusion Criteria
Age 18 or older
Diagnosis of colonic and/or distal ileal CD
Exclusion Criteria
Absence of written informed consent
Concomitant corticosteroid usage
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative incidence of persistent disease flares in 48 weeks of follow-up. A persistent flare is defined as two of three of the following criteria persisting for > 8 weeks, despite dose escalation of adalimumab; FC >250 µg/g, CRP=10 mg/L, HBI =5. Non-inferiority is reached if the difference in cumulative incidence of persistent flares not exceeds the non-inferiority margin of 15%.
- Secondary Outcome Measures
Name Time Method  Cumulative incidence of transient disease flares. A transient flare is defined as two of three of the following criteria persisting for = 8 weeks; FC >250 µg/g, CRP=10 mg/L, HBI =5. <br /><br> (Serious) adverse event rate. (Serious) adverse events that are (possibly) related to adalimumab and the (Serious) adverse events that are (possibly) related to adalimumab interval lengthening in the intervention and control group, expressed as events/ 100 PYs of follow-up. <br /><br> Factors that are associated with successful interval lengthening, e.g. baseline patient and treatment characteristics, FC, CRP, adalimumab drug levels and antibodies to adalimumab<br /><br> The decremental cost effectiveness ratio of this interval lengthening strategy. Dividing the difference in costs (based on medical consumption (by iMTA MCQ questionnaire) and work productivity (by iMTA PCQ questionnaire)) by the difference in QALYs (based on EQ-5D). <br />