The Nordic IBD Treatment Strategy Trial (NORDTREAT)

• ClinicalTrials.gov Identifier: NCT05180175
• Recruitment Status: Recruiting
• First Posted: January 6, 2022
• Last Update Posted: April 13, 2022
• Sponsor: Region Örebro County
• Information provided by (Responsible Party): Region Örebro County

Study Description

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: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.

Condition or disease	Intervention/treatment	Phase
Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease	Drug: Top down treatment if patient at high risk	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Nordic IBD Treatment Strategy Trial- a Randomised Controlled Trial of Access to a Protein Profile
• Actual Study Start Date: February 7, 2022
• Estimated Primary Completion Date: January 10, 2024
• Estimated Study Completion Date: July 10, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Clinical/Endoscopy remission and response [ Time Frame: Week 52 ]
   1. Proportion of subjects with clinical remission at 52 weeks
   2. Proportion of subjects with endoscopic remission at 52 weeks
   3. Proportion of subjects with clinical response
   4. Proportion of subjects with endoscopic response
   5. The proportion of patients with drug-related adverse events

Eligibility Criteria

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

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
• Other serious medical or psychiatric illness

Contacts and Locations

Contacts

Contact: Jonas Halfvarsson, MD, PhD; +46 19 602 1000; jonas.halfvarson@regionorebrolan.se

Contact: General contact; nordtreat@oru.se

Locations

Denmark

Odense University Hospital; Recruiting

Odense, Denmark, 5000

Contact: Jens Kjeldsen

OUH Svendborg Hospital; Recruiting

Svendborg, Denmark, 5700

Contact: Claus Aalykke

Hospital Sønderjylland; Recruiting

Åbenrå, Denmark, 6200

Contact: Vibeke Andersen

Iceland

Landspitali; Recruiting

Reykjavík, Iceland, 101

Contact: Loa Davidsdottir

Norway

Vestre Viken HF; Recruiting

Drammen, Norway, 3004

Contact: Svein Frigstad

Østfold Kalnes; Recruiting

Grålum, Norway, 1714

Contact: Henrik Wahlberg

Oslo Universitetssykehus; Recruiting

Oslo, Norway, 0424

Contact: Asle Medhus

Sykehuset i Telemark; Recruiting

Skien, Norway, 3710

Contact: Gert Huppertz Hauss

Sykehuset i Vestfold; Recruiting

Tønsberg, Norway, 3103

Contact: Tone Bergene Aabrekk

Sweden

Höglandssjukhuset Eksjö; Recruiting

Eksjö, Region Jönköpings Län, Sweden, 57581

Contact: Martin Rejler

Karolinska Universitetssjukhuset; Recruiting

Stockholm, Region Stockholm, Sweden, 17176

Contact: Charlotte Hedin

Akademiska Sjukhuet Uppsala; Recruiting

Uppsala, Region Uppsala, Sweden, 75185

Contact: Marie Carlson

Universitetssjukhuset i Linköping; Recruiting

Linköping, Region Östergötland, Sweden, 58185

Contact: Henrik Hjortswang

Ersta sjukhus; Recruiting

Stockholm, Sweden, 11691

Contact: Adam Carstens

Universitetssjukhuset Örebro; Recruiting

Örebro, Örebro Län, Sweden, 70185

Contact: Jonas Halfvarson

Sponsors and Collaborators

Region Örebro County

More Information

• Responsible Party: Region Örebro County
• ClinicalTrials.gov Identifier: NCT05180175
• Other Study ID Numbers: 274300
• First Posted: January 6, 2022
• Last Update Posted: April 13, 2022
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases