Guselkumab in Crohn's Disease: Optimising Care for Real-World Patients (OPTIM Study A)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

OPTIM Study A is a prospective, open-label, multicenter interventional trial evaluating the one-year real-world effectiveness of guselkumab in adults with Crohn's disease. The study also examines whether increasing guselkumab dosing from 100 mg every 8 weeks to 200 mg every 4 weeks benefits patients with loss of response, and whether intensified 200 mg q4w maintenance helps primary non-responders after induction. Primary and secondary outcomes focus on response, remission, and factors associated with the effectiveness of intensification. Eligible participants include adults with active Crohn's disease, with or without prior advanced therapy, who meet safety criteria and have active disease confirmed by objective measures. The trial is led by the Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives and conducted at multiple centers, including Chu Amiens Picardie in Amiens.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* \- Patients with a diagnosis of CD according to ECCO guidelines,
* 18 years of age or older at the time of informed consent,
* Absence of contraindication to guselkumab,
* Active disease according to PRO2 (abdominal pain \> 1 or stool frequency \> 3), and faecal calprotectin \> 250 ug/g,
* Objective active disease documented within ≤ 2 months by endoscopy or by MRI when not contraindicated, orby IUS),
* Not currently participating in any interventional research.
* Patient naïve or exposed to one or more advanced therapy, in accordance with the approved indication for guselkumab in Crohn's disease.
* Females of childbearing potential must have a negative serum pregnancy test at the baseline Visit.

Exclusion Criteria:

* \- Patient under legal protection,
* Previous exposure to an anti-IL23
* Combination of advanced therapy with GUS,
* Patient with ostomy,
* Pregnant or breastfeeding woman,
* Patient with perianal CD predominant disease.
* Active clinically significant infection or HIV, Hep B, Hep C, or active tuberculosis

Where it's running

• Chu Amiens Picardie
  Amiens, France Recruiting

Study contacts

• Principal investigator: Mathurin Fumery, Investigator — Hospital of Amiens, France
• Study coordinator: Mira Raad
• Email: mraad@getaid.org
• Phone: 0033 6 85 29 97 64

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.