Medical Treatment Versus Surgery in Stricturing Small Bowel Crohn's Disease

Sponsor
Nantes University Hospital
Study ID
NCT05584228
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Azathioprine + infliximab — DRUG
    Combination therapy using 2-2.5 mg/kg oral azathioprine plus subcutaneous infliximab
  • Intestinal resection — PROCEDURE
    Ileocolonic or small bowel resection

Study Details

The objective of the SMART trial is to compare a combination therapy using azathioprine and subcutaneous infliximab versus ileocecal resection in patients with symptomatic small bowel Crohn's disease.

Key Dates

First listed
Oct 18, 2022
Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Apr 1, 2030
Completion
Apr 1, 2031

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Medical treatment
    Combination therapy with subcutaneous infliximab and azathioprine
  • Active Comparator: Surgery
    Intestinal resection

Primary Outcome Measure

IBD (inflammatory bowel disease) - related quality of life [ Time Frame: 12 months ]

Central Contacts

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