Stavanger IBD Study - Cross Sectional (SUSI-CS)

Helse Stavanger HF

Status: Active, not recruiting

Conditions: Inflammatory Bowel Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02134054

SUSI-CS_1

Details and patient eligibility

About

In this cross sectional and longitudinal study, patients with inflammatory bowel disease on biological treatment with infliximab or adalimumab will be included.

After inclusion, the dosage of their existing biological therapy will be adjusted following regular trough-level and antibody-level monitoring, according to a treatment algorithm.

Disease activity markers, fatigue and QoL will be assessed during the study. The hypothesis is that therapeutic drug monitoring may improve clinical disease outcome after one year of follow-up.

Enrollment: 210 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with inflammatory bowel disease on treatment with infliximab or adalimumab of any duration (at least 3 doses)

Exclusion criteria

• Inability to consent
• Inability to adhere to treatment protocol.

Trial design

210 participants in 1 patient group

Biologic

Description:

Patients on treatment with biologics (infliximab or adalimumab)