Inflammatory Bowel DiseasesPhase 4NORDTREATNCT05180175
The Nordic IBD Treatment Strategy Trial
A Phase 4 study testing Top down treatment if patient at high risk in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by Region Örebro County at 15 sites in 4 countries.
Trial summary
Purpose: To demonstrate that personalised therapy can be delivered to patients with IBD, by treating patients with an increased risk of poor disease course, defined by a serum protein signature at diagnosis, with a top-down treatment, and that this treatment strategy improves clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Top down treatment if patient at high risk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 7 Feb 2022to 24 Jan 2025
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- UC or CD diagnosed within < 4 weeks using standard endoscopic, histologic or radiological criteria (ECCO Criteria). Histology report may not be available at baseline.
- Naïve to immunomodulators, biologics and small molecules, i.e. JAK-inhibitors
- Aged 18-70 years old.
- Is considered eligible according to tuberculosis (TB) screening criteria.
- Written informed consent to participate in the study
Who cannot join
- A previous known diagnosis of Crohn's disease, ulcerative colitis or IBD-U, since >6 weeks before baseline
- Unable to provide informed consent
- Unable to comply with protocol requirements (e.g. for reasons including alcohol and/or recreational drug abuse)
- Ongoing sepsis
- Acute obstructive symptoms AND evidence of a fixed stricture on radiology or colonoscopy, which suggest that the patient is in need of surgery over the following year. N.B. patients with modest degrees of stricturing on imaging but no obstructive symptoms may be included according to clinician judgement
- Contra-indications to trial medications including a history of hepatitis B or C, tuberculosis, Cardiac failure, NYHA III-IV or hypersensitivity. Hypersenstitivity to a thiopurine agent should alert the prescriber to probable hypersensitivity to other thiopurines.
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- History of malignancy
- Pregnancy at baseline
- Other serious medical or psychiatric illness
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Sweden6 sites
Höglandssjukhuset Eksjö
Eksjö, Region Jönköpings Län, 57581
Universitetssjukhuset i Linköping
Linköping, Region Östergötland, 58185
Universitetssjukhuset Örebro
Örebro, Örebro County, 70185
Karolinska Universitetssjukhuset
Stockholm, Region Stockholm, 17176
Ersta sjukhus
Stockholm, Stockholm County, 11691
Akademiska Sjukhuet Uppsala
Uppsala, Region Uppsala, 75185
Norway5 sites
Vestre Viken HF
Drammen, 3004
Østfold Kalnes
Grålum, 1714
Oslo Universitetssykehus
Oslo, 0424
Sykehuset i Telemark
Skien, 3710
Sykehuset i Vestfold
Tønsberg, 3103
Denmark3 sites
Hospital Sønderjylland
Aabenraa, 6200
Odense University Hospital
Odense, 5000
OUH Svendborg Hospital
Svendborg, 5700
About this study
Official title: The Nordic IBD Treatment Strategy Trial- a Randomised Controlled Trial of Access to a Protein Profile
Purpose:
To demonstrate that personalised therapy can be delivered to patients with IBD, by treating patients with an increased risk of poor disease course, defined by a serum protein signature at diagnosis, with a top-down treatment, and that this treatment strategy improves clinical outcomes.
Read more
Objectives:
Primary objective: To assess if a top-down treatment can improve treatment outcomes in IBD patients with a high risk of poor disease course, defined by a serum protein signature at diagnosis.
Secondary objective: To assess if a top-down treatment can improve quality of life and health resource allocation in IBD patients with a high risk of poor disease course, defined by a serum protein signature at diagnosis.
Study design:
A multi-centre, biomarker-stratified open-label controlled trial, where newly diagnosed IBD patients are randomised (1:1) to a group with access to the protein signature or a group without access to the protein signature. Study subjects within the protein signature arm who display a high-risk protein profile, will be treated according to a top-down treatment algorithm (anti-TNF agent with/without an immunomodulatory) and subjects without access to the protein signature will be treated according to current clinical practice.
Study population:
Newly diagnosed IBD patients.
Number of subjects: 300
Primary variables:
Composite of both corticosteroid-free clinical remission and endoscopic remission at Week 52, defined as below. Surgery because of IBD during follow-up will be defined as treatment failure.
Ulcerative colitis;
- Clinical remission per patient reported Mayo: A stool frequency subscore (SFS) ≤ 1, and not greater than baseline, and a rectal bleeding subscore (RBS) of 0.
- Endoscopic remission: An endoscopic Mayo subscore of 0 (OR in patients without endoscopy at week 52, normalization of f-Calprotectin, defined as < 250μg/g
Crohn's disease;
- Clinical remission: An average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
- Endoscopic remission: SES-CD≤2 (OR in patients without endoscopy at week 52, normalization of f-Calprotectin, defined as < 250μg/g.
- Being tested
- Top down treatment if patient at high risk
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Top down treatment if patient at high riskDrug
Patients with an increased risk of poor disease course (as defined by a serum protein signature at diagnosis), will be treated with a top down treatment strategy.
| Study group | Role | What they receive |
|---|---|---|
| Access to protein profile | Experimental | Not described Receives: Drug: Top down treatment if patient at high risk |
| No access to protein profile | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and endoscopic remission
Composite of proportion of subjects with both corticosteroid-free clinical remission and endoscopic remission at Week 52. Surgery because of IBD during follow-up will be defined as treatment failure.
Measured: Week 52
Secondary outcomes (1)
Clinical/Endoscopy remission and response
- Proportion of subjects with clinical remission at 52 weeks
- Proportion of subjects with endoscopic remission at 52 weeks
- Proportion of subjects with clinical response
- Proportion of subjects with endoscopic response
- The proportion of patients with drug-related adverse events
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start7 Feb 2022
- Primary completion24 Jan 2025
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180175
- Sponsor's protocol ID
- NT-2020
- Acronym
- NORDTREAT
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2021
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rejler M, Fuchtbauer JD, Daviethsdottir LG, Fejrskov A, Soderholm JD, Christensen R, Andersen V, Repsilber D, Kjeldsen J, Hoivik M, Halfvarson J. Nordic inflammatory bowel disease treatment strategy trial: protocol for the NORDTREAT randomised controlled biomarker-strategy trial. BMJ Open. 2024 Jul 31;14(7):e083163. doi: 10.1136/bmjopen-2023-083163.
PubMed 39089718
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nordic IBD Treatment Strategy Trial- a Randomised Controlled Trial of Access to a Protein Profile
- ClinicalTrials.gov ID
- NCT05180175
- Acronym / sponsor ID
- NORDTREAT / NT-2020
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 6 Jan 2022 (actual)
- 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.
Purpose:
To demonstrate that personalised therapy can be delivered to patients with IBD, by treating patients with an increased risk of poor disease course, defined by a serum protein signature at diagnosis, with a top-down treatment, and that this treatment strategy improves clinical outcomes.
Objectives:
Primary objective: To assess if a top-down treatment can improve treatment outcomes in IBD patients with a high risk of poor disease course, defined by a serum protein signature at diagnosis.
Secondary objective: To assess if a top-down treatment can improve quality of life and health resource allocation in IBD patients with a high risk of poor disease course, defined by a serum protein signature at diagnosis.
Study design:
A multi-centre, biomarker-stratified open-label controlled trial, where newly diagnosed IBD patients are randomised (1:1) to a group with access to the protein signature or a group without access to the protein signature. Study subjects within the protein signature arm who display a high-risk protein profile, will be treated according to a top-down treatment algorithm (anti-TNF agent with/without an immunomodulatory) and subjects without access to the protein signature will be treated according to current clinical practice.
Study population:
Newly diagnosed IBD patients.
Number of subjects: 300
Primary variables:
Composite of both corticosteroid-free clinical remission and endoscopic remission at Week 52, defined as below. Surgery because of IBD during follow-up will be defined as treatment failure.
Ulcerative colitis;
- Clinical remission per patient reported Mayo: A stool frequency subscore (SFS) ≤ 1, and not greater than baseline, and a rectal bleeding subscore (RBS) of 0.
- Endoscopic remission: An endoscopic Mayo subscore of 0 (OR in patients without endoscopy at week 52, normalization of f-Calprotectin, defined as < 250μg/g
Crohn's disease;
- Clinical remission: An average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
- Endoscopic remission: SES-CD≤2 (OR in patients without endoscopy at week 52, normalization of f-Calprotectin, defined as < 250μg/g.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Access to protein profile | Experimental | Drug: Top down treatment if patient at high risk |
| No access to protein profile | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- UC or CD diagnosed within < 4 weeks using standard endoscopic, histologic or radiological criteria (ECCO Criteria). Histology report may not be available at baseline.
- Naïve to immunomodulators, biologics and small molecules, i.e. JAK-inhibitors
- Aged 18-70 years old.
- Is considered eligible according to tuberculosis (TB) screening criteria.
- Written informed consent to participate in the study
Key exclusion criteria (9 listed)
- A previous known diagnosis of Crohn's disease, ulcerative colitis or IBD-U, since >6 weeks before baseline
- Unable to provide informed consent
- Unable to comply with protocol requirements (e.g. for reasons including alcohol and/or recreational drug abuse)
- Ongoing sepsis
- Acute obstructive symptoms AND evidence of a fixed stricture on radiology or colonoscopy, which suggest that the patient is in need of surgery over the following year. N.B. patients with modest degrees of stricturing on imaging but no obstructive symptoms may be included according to clinician judgement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Top down treatment if patient at high riskPatients with an increased risk of poor disease course (as defined by a serum protein signature at diagnosis), will be treated with a top down treatment strategy. | Drug | Access to protein profile |
Primary outcome
Clinical and endoscopic remission
Time frame: Week 52
Composite of proportion of subjects with both corticosteroid-free clinical remission and endoscopic remission at Week 52. Surgery because of IBD during follow-up will be defined as treatment failure.
1 secondary outcome
Clinical/Endoscopy remission and response
Time frame: Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Derived from this study: PubMed 39089718Rejler M, Fuchtbauer JD, Daviethsdottir LG, Fejrskov A, Soderholm JD, Christensen R, Andersen V, Repsilber D, Kjeldsen J, Hoivik M, Halfvarson J. Nordic inflammatory bowel disease treatment strategy trial: protocol for the NORDTREAT randomised controlled biomarker-strategy trial. BMJ Open. 2024 Jul 31;14(7):e083163. doi: 10.1136/bmjopen-2023-083163.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Top down treatment if patient at high risk in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by Region Örebro County at 15 sites in 4 countries.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Sweden, Norway, Denmark, Iceland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and endoscopic remission (time frame: Week 52). 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 NCT05180175, which also lists 1 linked publication.
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 10 Dec 2025.