engthening Adalimumab Dosing Interval in quiescent Crohn*s disease patients: the LADI study.

Phase 4

Recruiting

• Conditions: Crohn's disease; 10017969

• Registration Number: NL-OMON47881
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 174

Inclusion Criteria

- Age 18 or older
- Diagnosis of colonic and/or distal ileal CD
- Sustained steroid-free clinical remission for 9 months whilst being treated with adalimumab at a stable dose
- Adalimumab dosed at 40 mg every 2 weeks
- Full clinical response and disease control, all three criteria below need to be fulfilled prior to enrollment:
1. Absence of intestinal or extra-intestinal symptoms, as judged by both patient and physician
2. Fecal calprotectin (FC) lower than 150 µg/g and CRP <10 mg/L
- If endoscopic remission was recently confirmed, FC can be lower than 250 µg/g
3. Harvey Bradshaw Index (HBI) <5

Exclusion Criteria

- Absence of written informed consent
- Concomitant corticosteroid usage
- Need for IBD-related surgery
- Actively draining peri-anal fistula
- Pregnancy or lactation
- Other significant medical conditions that might interfere with this study (such as current/recent malignancy, immunodeficiency syndromes and psychiatric illness)
- Impossibility to measure outcomes, e.g. planned relocation, language issues, short life expectancy

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: The difference in cumulative incidence of persistent flares<br /><br>between the dose reduction and usual care groups at 48-week follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes<br /><br>• Cumulative incidence of patients with transient flare (duration <8 weeks)<br /><br>• Disease activity measured by HBI<br /><br>• PROM: PRO-2 (abdominal pain and stool frequency).<br /><br>• Adalimumab trough levels<br /><br>• Anti-adalimumab antibody levels<br /><br>• Adverse event rates (including injection site reactions and infections)<br /><br>• Quality of life (IBDQ and EQ-5D-5L)<br /><br>• Costs from a health care and societal perspective<br /><br>• Medication changes during 2 year observational follow-up</p><br>