In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels.

Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003068-39-NL

Enrollment

Registered

2019-11-04

Start date

2019-11-20

Completion date

Unknown

Last updated

2020-11-30

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

Conditions

Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease

Interventions

Trade Name: Infliximab Product Name: Infliximab Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/kg

Eligibility

Sex/Gender

All

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=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Planned step-up therapy

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether the area under the curve (AUC) of the infliximab serum concentration during one infusion cycle predicts relapse within one year after drug withdrawal in IBD patients in remission;Secondary Objective: To determine whether the Cmax and duration of detectable infliximab concentration predict relapse within one year after drug withdrawal in IBD patients in remission;Primary end point(s): Relapse, defined as: - Endoscopical relapse (SESCD >4; eMayo 3); or - Clinical + biochemical (CRP>10 or FCP>250) relapse without endoscopy performed; or - IBD-related hospitalization, surgery; or - Occurrence of IBD-related complications (abscess, stenosis, fistula);Timepoint(s) of evaluation of this end point: every 3 months until 1/2 years after withdrawal of infliximab	—

Measure

Time frame

Main Objective: To determine whether the area under the curve (AUC) of the infliximab serum concentration during one infusion cycle predicts relapse within one year after drug withdrawal in IBD patients in remission;Secondary Objective: To determine whether the Cmax and duration of detectable infliximab concentration predict relapse within one year after drug withdrawal in IBD patients in remission;Primary end point(s): Relapse, defined as: - Endoscopical relapse (SESCD >4; eMayo 3); or - Clinical + biochemical (CRP>10 or FCP>250) relapse without endoscopy performed; or - IBD-related hospitalization, surgery; or - Occurrence of IBD-related complications (abscess, stenosis, fistula);Timepoint(s) of evaluation of this end point: every 3 months until 1/2 years after withdrawal of infliximab

—

Secondary

Measure	Time frame
Secondary end point(s): Endoscopical relapse rate - Clinical + biochemical relapse rate - Occurrence of IBD related complications;Timepoint(s) of evaluation of this end point: every 3 months until 1/2 years after withdrawal of infliximab	—

Countries

Netherlands

Contacts

Public ContactPhD candidate

UMC Utrecht

r.mahmoud-2@umcutrecht.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026