Recruiting

Testing a new medication approach for newly diagnosed Crohn's disease

Plain-English translation of NCT03917303 on ClinicalTrials.gov ↗ · Source last updated September 2022 · Translation generated June 2026 ·

What is this trial?

This trial is testing whether , a biologic medication, can work better as a first-line treatment for people newly diagnosed with Crohn's disease. Right now, doctors typically start with corticosteroids and gradually add stronger medications if needed. This study asks: can starting with the medication work just as well while reducing side effects and unnecessary treatment for patients who may not need it?

Crohn's disease is unpredictable—some patients do well with mild treatment, while others develop serious complications. The current step-up approach means many patients spend months on steroids or wait too long for stronger medication. This trial explores whether starting with this medication could improve outcomes while avoiding overtreatment in patients who don't need aggressive therapy.

Do you qualify?

You likely qualify if…

you have been newly diagnosed with Crohn's disease or are experiencing a flare
your diagnosis has been confirmed with a complete colonoscopy and small bowel imaging (MRI or CT scan)
you have never taken biologic medications before
you are between 18 and 70 years old
you speak Dutch fluently and have a smartphone with internet access
you are willing to use a digital health app called myIBDcoach to track your symptoms

You likely don't qualify if…

you have taken corticosteroids for more than 4 weeks in the past year
you have taken thiopurine medications in the past 3 years
you have a history of cancer in the past 5 years (except for certain skin cancers)
you have medical conditions that prevent you from safely taking TNF-blocker medications or immunosuppressive drugs
you have had bowel surgery that created an ostomy or removed significant portions of your small intestine

What participation looks like

If you join the trial, you'll be randomly assigned to either receive the medication as a first-line treatment for 6 months, or to follow the approach starting with corticosteroids. You'll visit the clinic regularly and use a smartphone app to track how you're feeling. The study will monitor your symptoms, bowel healing, and any side effects over time to see which approach works better for newly diagnosed patients.

Testing a new medication approach for newly diagnosed Crohn's disease

What is this trial?

Do you qualify?

What participation looks like

Trial locations(6 sites)