The Nordic IBD Treatment Strategy Trial (NORDTREAT)

  • STATUS
    Recruiting
  • End date
    Jul 10, 2024
  • participants needed
    250
  • sponsor
    Region Örebro County
Updated on 30 April 2022
remission
endoscopy
abdominal pain
ulcerative colitis
crohn's disease
colitis
ulceration
immunomodulators
hematochezia

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:250

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.

Details
Condition Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
Treatment Top down treatment if patient at high risk
Clinical Study IdentifierNCT05180175
SponsorRegion Örebro County
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

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
Other serious medical or psychiatric illness
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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