Integrated pharmacokinetics of infliximab, adalimumab and golimumab in serum, tissue and faeces of patients with moderate to severe Ulcerative Colitis and Crohn's Colitis

Integrated pharmacokinetics of infliximab, adalimumab and golimumab in serum, tissue and faeces of patients with moderate to severe Ulcerative Colitis and Crohn's Colitis - Three compartment PK study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47648

Enrollment

Registered

2015-09-22

Start date

2016-02-16

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/Crohn's colitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients aged * 18 years, either male or female, moderate to severe Ulcerative Colitis or Crohns* colitis (respectively according to Mayo score (2 or 3) or SES-CD (*7) at baseline endoscopy), starting on Infliximab, adalimumab or golimumab at regular doses.

Exclusion criteria

Exclusion criteria: Contra-indications to anti-TNF treatment, imminent need for surgery.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this exploratory study will be the relationship between anti-TNF and TNF levels in serum, tissue and feces at different timepoints in patients with moderate to severe colitis.	—

Secondary

Measure	Time frame
The correlation between primary response to those agents (clinical, biochemical en endoscopic improvement) and drug levels in these three compartments.	—

Countries

Netherlands

Outcome results