Clinical trial NCT05180175: The Nordic IBD Treatment Strategy Trial
Official title: The Nordic IBD Treatment Strategy Trial- a Randomised Controlled Trial of Access to a Protein Profile
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Inflammatory Bowel Diseases
Ulcerative Colitis
Crohn Disease
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Clinical and endoscopic remission
timeFrame: Week 52
Secondary outcomes:
measure: Clinical/Endoscopy remission and response
timeFrame: Week 52
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
city: Svendborg
country: Denmark
facility: OUH Svendborg Hospital
city: Åbenrå
country: Denmark
facility: Hospital Sønderjylland
city: Reykjavík
country: Iceland
facility: Landspitali
city: Drammen
country: Norway
facility: Vestre Viken HF
city: Grålum
country: Norway
facility: Østfold Kalnes
city: Oslo
country: Norway
facility: Oslo Universitetssykehus
city: Skien
country: Norway
facility: Sykehuset i Telemark
city: Tønsberg
country: Norway
facility: Sykehuset i Vestfold
city: Eksjö
country: Sweden
facility: Höglandssjukhuset Eksjö
state: Region Jönköpings Län
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
state: Region Stockholm
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuet Uppsala
state: Region Uppsala
city: Linköping
country: Sweden
facility: Universitetssjukhuset i Linköping
state: Region Östergötland
city: Stockholm
country: Sweden
facility: Ersta sjukhus
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
state: Örebro Län
Study officials:
References: