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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40152
Enrollment
72
Registered
2014-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBD

Interventions

ADA dose interval lengthened from 2 weeks to 3 weeks

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Secondary

MeasureTime frame
-Relapse rates in both groups, defined by increase of fecal calprotectin and/or CRP and clinical activity, and subsequently confirmed by endoscopy -Tolerability

Primary

MeasureTime frame
Patients in remission after 24 weeks

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)