Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
210 participants
OBSERVATIONAL
2014-04-30
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Stavanger University Hospital Inflammatory Bowel Disease Trial
NCT01551563
Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease
NCT02073526
A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
NCT03251118
An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice
NCT05494606
Inflammatory Bowel Disease(IBD), Treatment Response
NCT05350644
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Biologic
Patients on treatment with biologics (infliximab or adalimumab)
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Inability to adhere to treatment protocol.
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rikshospitalet University Hospital
OTHER
Oslo University Hospital
OTHER
Helse Stavanger HF
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tore B Grimstad, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stavanger University Hospital, Department of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stavanger University Hospital
Stavanger, , Norway
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SUSI-CS_1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.