Inflammatory Bowel DiseaseSUSI-CSNCT02134054
Stavanger IBD Study - Cross Sectional
An observational study of Inflammatory Bowel Disease, run by Helse Stavanger HF at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 210 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2014to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with inflammatory bowel disease established (minimum 3 doses) on treatment with infliximab or adalimumab
Who may be able to join
- Patients diagnosed with inflammatory bowel disease on treatment with infliximab or adalimumab of any duration (at least 3 doses)
Who cannot join
- Inability to consent
- Inability to adhere to treatment protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stavanger University Hospital IBD Study - a Cross Sectional Longitudinal Study on Patients Treated With Biologics
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
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Biologic | Patients on treatment with biologics (infliximab or adalimumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rate
Harvey Bradshaw Index <5 Partial Mayo score <=2
Measured: One Year
Secondary outcomes (3)
Symptom scoring
Harvey Bradshaw Index, Partial Mayo Score. Change after therapeutic drug monitoring.
Measured: One Year
Inflammatory markers
C reactive protein, Fecal Calprotectin. Change after therapeutic drug monitoring.
Measured: One year
Fatigue scoring
Assessed by Fatigue severity scale and Visual analogue scale. Change after therapeutic drug monitoring.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2015
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Rikshospitalet University Hospital, Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Tore B Grimstad, MD, PhD, Principal investigator, Stavanger University Hospital, Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134054
- Sponsor's protocol ID
- SUSI-CS_1
- Acronym
- SUSI-CS
- Status last verified
- Nov 2023
- First submitted
- 29 Apr 2014
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 40289444Carlsen 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.
PubMed 29623105
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stavanger University Hospital IBD Study - a Cross Sectional Longitudinal Study on Patients Treated With Biologics
- ClinicalTrials.gov ID
- NCT02134054
- Acronym / sponsor ID
- SUSI-CS / SUSI-CS_1
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Therapeutic drug monitoring, Biological treatment, IBD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Rikshospitalet University Hospital, Oslo University Hospital
- Study start
- Apr 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biologic | – | –Patients on treatment with biologics (infliximab or adalimumab) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with inflammatory bowel disease established (minimum 3 doses) on treatment with infliximab or adalimumab
Key inclusion criteria (1 listed)
- Patients diagnosed with inflammatory bowel disease on treatment with infliximab or adalimumab of any duration (at least 3 doses)
Key exclusion criteria (2 listed)
- Inability to consent
- Inability to adhere to treatment protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical remission rate
Time frame: One Year
Harvey Bradshaw Index <5 Partial Mayo score <=2
3 secondary outcomes
Symptom scoring
Time frame: One Year
Inflammatory markers
Time frame: One year
Fatigue scoring
Time frame: One Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 40289444Grimstad 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.
- Derived from this study: PubMed 29623105Carlsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tore B Grimstad, MD, PhD principal investigator
Stavanger University Hospital, Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02134054, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.