The Nordic IBD Treatment Strategy Trial

NCT05180175 | Completed Phase 4

• 1 other identifier: NT-2020
• Study Type: interventional
• Target: 300
• Locations: 4 countries
• Sites: 15

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

Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical/Endoscopy remission and response

  Week 52

Study Arms (2)

Access to protein profile

EXPERIMENTAL

Drug: Top down treatment if patient at high risk

No access to protein profile

NO INTERVENTION

Interventions

Top down treatment if patient at high risk 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.

Access to protein profile

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (15)

Hospital Sønderjylland

Aabenraa, 6200, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

OUH Svendborg Hospital

Svendborg, 5700, Denmark

Location

Landspitali

Reykjavik, 101, Iceland

Location

Vestre Viken HF

Drammen, 3004, Norway

Location

Østfold Kalnes

Grålum, 1714, Norway

Location

Oslo Universitetssykehus

Oslo, 0424, Norway

Location

Sykehuset i Telemark

Skien, 3710, Norway

Location

Sykehuset i Vestfold

Tønsberg, 3103, Norway

Location

Höglandssjukhuset Eksjö

Eksjö, Region Jönköpings Län, 57581, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, Region Stockholm, 17176, Sweden

Location

Akademiska Sjukhuet Uppsala

Uppsala, Region Uppsala, 75185, Sweden

Location

Universitetssjukhuset i Linköping

Linköping, Region Östergötland, 58185, Sweden

Location

Ersta sjukhus

Stockholm, Stockholm County, 11691, Sweden

Location

Universitetssjukhuset Örebro

Örebro, Örebro County, 70185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 39089718 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: February 7, 2022
• Primary Completion: January 24, 2025
• Study Completion: January 24, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1); NO (5); SE (6); DK (3)