Study of the pharmacokinetics of golimumab in moderate to severe Ulcerative Colitis

Study of the pharmacokinetics of golimumab in moderate to severe Ulcerative Colitis - GO-KINETIC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44551

Enrollment

Registered

2014-07-28

Start date

2014-09-02

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

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), both anti-TNF naïve and anti-TNF exposed patients will be included -Baseline endoscopy -Obtained written informed consent

Exclusion criteria

Exclusion criteria: - Contra-indication to golimumab: TBC, severe infections or congestive heart failure. - Imminent need for surgery

Design outcomes

Primary

Measure	Time frame
Drug level of golimumab at several time points.	—

Secondary

Measure	Time frame
Development of anti-drug antibodies, fecal calprotectin, fecal golimumab drug levels, serum CRP, albumin level, SCCAI, IBDQ, SF-36 and endoscopies at different time points.	—

Countries

Netherlands

Outcome results