Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Rikshospitalet University Hospital | OTHER |
| Oslo University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biologic | Patients on treatment with biologics (infliximab or adalimumab) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission rate | Harvey Bradshaw Index <5 Partial Mayo score <=2 | One Year |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom scoring | Harvey Bradshaw Index, Partial Mayo Score. Change after therapeutic drug monitoring. | One Year |
| Inflammatory markers | C reactive protein, Fecal Calprotectin. Change after therapeutic drug monitoring. |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare resource utilization | Registration of
| One year |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with inflammatory bowel disease established (minimum 3 doses) on treatment with infliximab or adalimumab
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tore B Grimstad, MD, PhD | Stavanger University Hospital, Department of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stavanger University Hospital | Stavanger | 4068 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40289444 | Derived | 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. | |
| 29623105 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Standard blood sampling Serum sampling - trough/antibodies of biological agent
| One year |
| Fatigue scoring | Assessed by Fatigue severity scale and Visual analogue scale. Change after therapeutic drug monitoring. | One Year |
| 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. Ther Adv Gastroenterol. 2018 Mar 14;11:1756284818759930. doi: 10.1177/1756284818759930. eCollection 2018. |