Stavanger IBD Study - Cross Sectional

NCT02134054 | Unknown

• 1 other identifier: SUSI-CS_1
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Disease

Keywords

Therapeutic drug monitoring; Biological treatment; IBD

Outcome Measures

Primary Outcomes (1)

• Clinical remission rate

  Harvey Bradshaw Index \<5 Partial Mayo score \<=2

  One Year

Secondary Outcomes (3)

• Symptom scoring

  One Year

• Inflammatory markers

  One year

• Fatigue scoring

  One Year

Other Outcomes (1)

• Healthcare resource utilization

  One year

Study Arms (1)

Biologic

Patients on treatment with biologics (infliximab or adalimumab)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with inflammatory bowel disease established (minimum 3 doses) on treatment with infliximab or adalimumab

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Helse Stavanger HF: lead
• Rikshospitalet University Hospital: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Stavanger University Hospital

Stavanger, 4068, Norway

Location

Related Publications (2)

• Grimstad T, Carlsen A, Kvaloy JT, Bolstad N, Warren DJ, Aabakken L, Lundin KEA, Karlsen L, Steinsbo O, Omdal R. Fatigue in Inflammatory Bowel Disease: No Effect of Serum Concentrations of Infliximab, Adalimumab or Anti-Drug Antibodies During Maintenance Therapy. Scand J Immunol. 2025 May;101(5):e70029. doi: 10.1111/sji.70029.

  PMID: 40289444 DERIVED

• Carlsen A, Omdal R, Leitao KO, Isaksen K, Hetta AK, Karlsen LN, Aabakken L, Bolstad N, Warren D, Lundin KEA, Grimstad T. Subtherapeutic concentrations of infliximab and adalimumab are associated with increased disease activity in Crohn's disease. Therap Adv Gastroenterol. 2018 Mar 14;11:1756284818759930. doi: 10.1177/1756284818759930. eCollection 2018.

  PMID: 29623105 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Standard blood sampling Serum sampling - trough/antibodies of biological agent

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Tore B Grimstad, MD, PhD

  Stavanger University Hospital, Department of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 8, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)