Evaluating treatment options for Crohn's disease

Control Crohn Safe With Episodic Adalimumab Monotherapy as First Line Treatment Study.

This study is testing if adding a medication called adalimumab to standard care can help people with newly diagnosed Crohn's disease or those having a flare feel better and avoid complications.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 158 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Maastricht University Medical Center (Academic / other)
• Drugs / interventions: prednisone, infliximab, Adalimumab
• Locations: 6 sites (Maastricht and 5 other locations)
• Trial ID: NCT03917303 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of adalimumab in combination with standard step-up care for patients with newly diagnosed Crohn's disease or those experiencing a flare. The study will involve patients who have undergone complete ileo-colonoscopy and imaging, ensuring they meet specific diagnostic criteria. Participants will be monitored for treatment response and potential complications, with a focus on improving long-term outcomes by introducing biological therapy early in the treatment process. The trial will utilize the myIBDcoach app to support patient management and engagement.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 70 who are newly diagnosed with Crohn's disease or experiencing a flare and are naïve to biological treatments.

Not a fit: Patients with a history of prolonged corticosteroid use, those requiring immediate biological treatment, or individuals with contraindications to TNF-blockers will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for Crohn's disease, potentially reducing complications and enhancing patient quality of life.

How similar studies have performed: Previous studies have shown that early introduction of TNF-blockers like infliximab can significantly improve long-term outcomes in Crohn's disease, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Newly diagnosed CD patients or CD patients with a flare, visiting the outpatient clinic or endoscopy ward of the participating centres
* CD diagnosis according to ECCO-guidelines + complete ileo-colonoscopy + complete small bowel imaging at diagnosis (MRI or CT-enterography )
* Naïve to biologicals
* Sufficient knowledge of Dutch language
* 18 years old ≤ 70 years old
* Smartphone with internet access
* Use of myIBDcoach or willingness to start using myIBDcoach

Exclusion Criteria:

* Use of prednisone for longer than 4 weeks in the year before screening
* Use of budesonide (≥6 mg daily) for a duration longer than 3 months in the year before screening
* Use of thiopurines in the 3 years before screening
* Indication for primary treatment with biologicals or surgery
* Malignancy in 5 years before treatment. Exception is adequately treated non-melanoma skin cancer
* Contra-indication for TNF-blockers or immunosuppressive agents
* Contra-indication for MRI- and CT-enterography
* Patients with short bowel syndrome or an ostomy

Where this trial is running

Maastricht and 5 other locations

• Maastricht University Medical Centre+ — Maastricht, Netherlands (Recruiting)
• St. Antonius Ziekenhuis — Nieuwegein, Netherlands (Recruiting)
• Laurentius Ziekenhuis — Roermond, Netherlands (Recruiting)
• Zuyderland Medical Center — Sittard, Netherlands (Recruiting)
• Máxima Medisch Centrum — Veldhoven, Netherlands (Recruiting)
• VieCuri — Venlo, Netherlands (Recruiting)

Study contacts

• Principal investigator: M J Pierik, MD, PhD — Maastricht University Medical Centre
• Study coordinator: M J Pierik, MD, PhD

Conditions Crohn Disease; Inflammatory Bowel Diseases