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Blood test guides smarter IBD treatment in landmark trial

NCT ID NCT05180175

Disease control Sponsor: Region Örebro County Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a blood test measuring proteins can help doctors choose the best treatment for people newly diagnosed with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. 300 patients were split into two groups: one where doctors had the protein test results and used a more aggressive treatment plan for high-risk patients, and another where doctors used standard care. The goal was to see if the personalized approach led to better disease control and quality of life after one year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

300 people

The number who actually took part.

Started

Feb 2022

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 at baseline * Other serious medical or psychiatric illness

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease Inflammatory bowel diseases Ulcerative colitis

Contacts and locations

Locations

  • Akademiska Sjukhuet Uppsala

    Uppsala, Region Uppsala, 75185, Sweden

  • Ersta sjukhus

    Stockholm, Stockholm County, 11691, Sweden

  • Hospital Sønderjylland

    Aabenraa, 6200, Denmark

  • Höglandssjukhuset Eksjö

    Eksjö, Region Jönköpings Län, 57581, Sweden

  • Karolinska Universitetssjukhuset

    Stockholm, Region Stockholm, 17176, Sweden

  • Landspitali

    Reykjavik, 101, Iceland

  • OUH Svendborg Hospital

    Svendborg, 5700, Denmark

  • Odense University Hospital

    Odense, 5000, Denmark

  • Oslo Universitetssykehus

    Oslo, 0424, Norway

  • Sykehuset i Telemark

    Skien, 3710, Norway

  • Sykehuset i Vestfold

    Tønsberg, 3103, Norway

  • Universitetssjukhuset i Linköping

    Linköping, Region Östergötland, 58185, Sweden

  • Universitetssjukhuset Örebro

    Örebro, Örebro County, 70185, Sweden

  • Vestre Viken HF

    Drammen, 3004, Norway

  • Østfold Kalnes

    Grålum, 1714, Norway

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