Withdrawal of INfliximab in patients with inflammatory bowel disease in remission guided by pharmacoKinetics: WINK study.

Withdrawal of INfliximab in patients with inflammatory bowel disease in remission guided by pharmacoKinetics: WINK study. - WINK study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49879

Enrollment

Registered

2019-11-04

Start date

2019-12-20

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

"Inflammatory bowel disease" "Ulcerative Colitis" "Crohn's Disease"

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age > 18 years - Diagnosis of IBD (Crohn*s Disease, Ulcerative colitis, IBD-U) - Use of IFX with at >1 remaining dose scheduled after informed consent - Clinical remission >6 months without IBD-related use of corticosteroids. - Undetectable trough level of IFX (last available measurement) - Endoscopic remission (SESCD

Exclusion criteria

Exclusion criteria: - No indication for additional IFX infusion in same dose and at same dosing interval as part of routine clinical practice. - Concomitant use of systemic steroids, ustekinumab, vedolizumab or jak-inhibitor (tofacitinib) at the time of IFX infusion with study measurements.

Design outcomes

Primary

Measure	Time frame
Primary Outcome: descriptive: interindividual variation in pharmacokinetic parameters. time-to-event: Relapse rate after withdrawal of anti-TNF within one year.	—

Secondary

Measure	Time frame
- Endoscopical relapse rate - Clinical + biochemical relapse rate - Occurrence of IBD related complications	—

Countries

Netherlands

Outcome results