The Nordic IBD Treatment Strategy Trial (NORDTREAT)

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.

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 Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Drug: Top down treatment if patient at high risk

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Aabenraa, Denmark, 6200
    • Hospital Sønderjylland
  • Odense, Denmark, 5000
    • Odense University Hospital
  • Svendborg, Denmark, 5700
    • OUH Svendborg Hospital
• Iceland
  • Reykjavik, Iceland, 101
    • Landspitali
• Norway
  • Drammen, Norway, 3004
    • Vestre Viken HF
  • Grålum, Norway, 1714
    • Østfold Kalnes
  • Oslo, Norway, 0424
    • Oslo Universitetssykehus
  • Skien, Norway, 3710
    • Sykehuset i Telemark
  • Tønsberg, Norway, 3103
    • Sykehuset I Vestfold
• Sweden
  • Region Jönköpings Län
    • Eksjö, Region Jönköpings Län, Sweden, 57581
      • Höglandssjukhuset Eksjö
  • Region Stockholm
    • Stockholm, Region Stockholm, Sweden, 17176
      • Karolinska Universitetssjukhuset
  • Region Uppsala
    • Uppsala, Region Uppsala, Sweden, 75185
      • Akademiska Sjukhuet Uppsala
  • Region Östergötland
    • Linköping, Region Östergötland, Sweden, 58185
      • Universitetssjukhuset i Linköping
  • Stockholm County
    • Stockholm, Stockholm County, Sweden, 11691
      • Ersta sjukhus
  • Örebro County
    • Örebro, Örebro County, Sweden, 70185
      • Universitetssjukhuset Örebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Access to protein profile	Drug: 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.
No Intervention: No access to protein profile

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Week 52

Collaborators and Investigators

• Sponsor: Region Örebro County

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Actual): January 24, 2025
• Study Completion (Actual): January 24, 2025

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: NT-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No