The Nordic IBD Treatment Strategy Trial (NORDTREAT)
Primary Purpose
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Top down treatment if patient at high risk
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases
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
Sites / Locations
- Odense University HospitalRecruiting
- OUH Svendborg HospitalRecruiting
- Hospital SønderjyllandRecruiting
- LandspitaliRecruiting
- Vestre Viken HFRecruiting
- Østfold KalnesRecruiting
- Oslo UniversitetssykehusRecruiting
- Sykehuset i TelemarkRecruiting
- Sykehuset i VestfoldRecruiting
- Höglandssjukhuset EksjöRecruiting
- Karolinska UniversitetssjukhusetRecruiting
- Akademiska Sjukhuet UppsalaRecruiting
- Universitetssjukhuset i LinköpingRecruiting
- Ersta sjukhusRecruiting
- Universitetssjukhuset ÖrebroRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Access to protein profile
No access to protein profile
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05180175
Brief Title
The Nordic IBD Treatment Strategy Trial
Acronym
NORDTREAT
Official Title
The Nordic IBD Treatment Strategy Trial- a Randomised Controlled Trial of Access to a Protein Profile
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
January 10, 2024 (Anticipated)
Study Completion Date
July 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Örebro County
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Access to protein profile
Arm Type
Experimental
Arm Title
No access to protein profile
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Top down treatment if patient at high risk
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical and endoscopic remission
Description
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.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Clinical/Endoscopy remission and response
Description
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
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonas Halfvarsson, MD, PhD
Phone
+46 19 602 1000
Email
jonas.halfvarson@regionorebrolan.se
First Name & Middle Initial & Last Name or Official Title & Degree
General contact
Email
nordtreat@oru.se
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Kjeldsen
Facility Name
OUH Svendborg Hospital
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claus Aalykke
Facility Name
Hospital Sønderjylland
City
Åbenrå
ZIP/Postal Code
6200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vibeke Andersen
Facility Name
Landspitali
City
Reykjavík
ZIP/Postal Code
101
Country
Iceland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loa Davidsdottir
Facility Name
Vestre Viken HF
City
Drammen
ZIP/Postal Code
3004
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Svein Frigstad
Facility Name
Østfold Kalnes
City
Grålum
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Wahlberg
Facility Name
Oslo Universitetssykehus
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asle Medhus
Facility Name
Sykehuset i Telemark
City
Skien
ZIP/Postal Code
3710
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gert Huppertz Hauss
Facility Name
Sykehuset i Vestfold
City
Tønsberg
ZIP/Postal Code
3103
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tone Bergene Aabrekk
Facility Name
Höglandssjukhuset Eksjö
City
Eksjö
State/Province
Region Jönköpings Län
ZIP/Postal Code
57581
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Rejler
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
State/Province
Region Stockholm
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Hedin
Facility Name
Akademiska Sjukhuet Uppsala
City
Uppsala
State/Province
Region Uppsala
ZIP/Postal Code
75185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Carlson
Facility Name
Universitetssjukhuset i Linköping
City
Linköping
State/Province
Region Östergötland
ZIP/Postal Code
58185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Hjortswang
Facility Name
Ersta sjukhus
City
Stockholm
ZIP/Postal Code
11691
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Carstens
Facility Name
Universitetssjukhuset Örebro
City
Örebro
State/Province
Örebro Län
ZIP/Postal Code
70185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonas Halfvarson
12. IPD Sharing Statement
Plan to Share IPD
No
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The Nordic IBD Treatment Strategy Trial
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