Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Observational pharmacokinetics study of adalimumab in patients with active refractory Crohn's disease who are naïve to TNF antagonist therapy.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Patients with confirmed diagnosis of Crohn's disease, fulfilling the criteria for reimbursement (Belgium).

• Patients with active disease defined as a Harvey-Bradshaw index >4 and/or a C-reactive protein concentration >5 mg/l.

• Informed consent.

Exclusion Criteria:

• Patients with ulcerative colitis.

• Patients treated in placebo controlled trials.

• Patients unwilling to participate or withdrawing informed consent for this study.