The Nordic IBD Treatment Strategy Trial

Ulcerative Colitis Clinical Trial

— NORDTREAT  

Official title:

The Nordic IBD Treatment Strategy Trial- a Randomised Controlled Trial of Access to a Protein Profile

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05180175
• Other study ID #: 274300
• Status: Recruiting
• Phase: Phase 4
• Start date: February 7, 2022
• Est. completion date: July 10, 2024

Study information

• Verified date: December 2021
• Source: Region Örebro County
• Contact: Jonas Halfvarsson, MD, PhD
• Phone: +46 19 602 1000
• Email: jonas.halfvarson[@]regionorebrolan.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 10, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
Denmark	Hospital Sønderjylland	Åbenrå
Denmark	Odense University Hospital	Odense
Denmark	OUH Svendborg Hospital	Svendborg
Iceland	Landspitali	Reykjavík
Norway	Vestre Viken HF	Drammen
Norway	Østfold Kalnes	Grålum
Norway	Oslo Universitetssykehus	Oslo
Norway	Sykehuset i Telemark	Skien
Norway	Sykehuset i Vestfold	Tønsberg
Sweden	Höglandssjukhuset Eksjö	Eksjö	Region Jönköpings Län
Sweden	Universitetssjukhuset i Linköping	Linköping	Region Östergötland
Sweden	Universitetssjukhuset Örebro	Örebro	Örebro Län
Sweden	Ersta sjukhus	Stockholm
Sweden	Karolinska Universitetssjukhuset	Stockholm	Region Stockholm
Sweden	Akademiska Sjukhuet Uppsala	Uppsala	Region Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Countries where clinical trial is conducted

Denmark,  Iceland,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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