engthening Adalimumab Dosing Interval in IBD patients in long term remission, the LADI study.

Phase 3

Withdrawn

• Conditions: IBD; 10017969

• Registration Number: NL-OMON40152
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

Age 18 or older
Written informed consent.
Previous diagnosis of ileocolonic Crohn*s disease or ulcerative colitis
In sustained clinical remission for at least 6 months whilst being treated with adalimumab
Adalimumab dosed at 40mg, once every 2 weeks
Full clinical response and disease control, defined as
-Absence of intestinal or extra-intestinal symptoms, as judged by both patient and physician
-Fecal calprotectin < 200 µg/g and CRP within normal range
-Full endoscopic remission (no ulcera) assessed at least within 12 months before inclusion
Permitted concomitant therapy: aminosalicylates, azathioprine, 6-mercatopurine and methotrexate at stable dose for 12 weeks

Exclusion Criteria

Imminent need for IBD-related surgery
Actively draining perianal fistula
Pregnancy or lactation
Other significant medical illness that might interfere with this study (such as current malignancy, immunodeficiency syndromes and psychiatric illness)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Patients in remission after 24 weeks</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Relapse rates in both groups, defined by increase of fecal calprotectin and/or<br /><br>CRP and clinical activity, and subsequently confirmed by endoscopy<br /><br>-Tolerability</p><br>