The Nordic IBD Treatment Strategy Trial

NCT ID: NCT05180175

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2025-01-24

Brief 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.

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.

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Access to protein profile

Group Type: EXPERIMENTAL

Top down treatment if patient at high risk

Intervention Type: DRUG

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.

No access to protein profile

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Top down treatment if patient at high risk

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• History of malignancy
• Pregnancy at baseline
• Other serious medical or psychiatric illness

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Sønderjylland

Aabenraa, , Denmark

Odense University Hospital

Odense, , Denmark

OUH Svendborg Hospital

Svendborg, , Denmark

Landspitali

Reykjavik, , Iceland

Vestre Viken HF

Drammen, , Norway

Østfold Kalnes

Grålum, , Norway

Oslo Universitetssykehus

Oslo, , Norway

Sykehuset i Telemark

Skien, , Norway

Sykehuset i Vestfold

Tønsberg, , Norway

Höglandssjukhuset Eksjö

Eksjö, Region Jönköpings Län, Sweden

Karolinska Universitetssjukhuset

Stockholm, Region Stockholm, Sweden

Akademiska Sjukhuet Uppsala

Uppsala, Region Uppsala, Sweden

Universitetssjukhuset i Linköping

Linköping, Region Östergötland, Sweden

Ersta sjukhus

Stockholm, Stockholm County, Sweden

Universitetssjukhuset Örebro

Örebro, Örebro County, Sweden

Countries

Denmark; Iceland; Norway; Sweden

References

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.

Reference Type: DERIVED

PMID: 39089718 (View on PubMed)

Other Identifiers

NT-2020

Identifier Type: -

Identifier Source: org_study_id