Study of the pharmacokinetics of Infliximab (IFX) in moderate to severe Ulcerative Colitis

Study of the pharmacokinetics of Infliximab (IFX) in moderate to severe Ulcerative Colitis - KINETIC druglevel Infliximab

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37516

Enrollment

Registered

2012-05-04

Start date

2012-07-09

Completion date

Unknown

Last updated

2024-04-29

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

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Age from 18 years, either male or female -Moderate to severe Ulcerative Colitis (according to Mayo score (2 or 3) baseline Colonoscopy) naïve to biologic therapy. -Baseline Colonoscopy -Obtained written informed consent

Exclusion criteria

Exclusion criteria: -History of anti-TNF treatment -Contra-indication to infliximab: TBC, severe infections or congestive heart failure. -Imminent need for surgery -Immunomodulators started in the last 4 weeks

Design outcomes

Primary

Measure	Time frame
Drug level of Infliximab at several time points	—

Secondary

Measure	Time frame
Development of antibodies, fecal calprotectin en serum CRP, Albumine level, Simple Clinical Colitis Activity Index, colonoscopy and biopsies at the different time points	—

Countries

Netherlands

Outcome results