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

NCT05584228 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-10-18

No results posted yet for this study

Summary

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.

Conditions

  • Crohn Disease

Interventions

DRUG

Azathioprine + infliximab

Combination therapy using 2-2.5 mg/kg oral azathioprine plus subcutaneous infliximab

PROCEDURE

Intestinal resection

Ileocolonic or small bowel resection

Sponsors & Collaborators

  • Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    collaborator OTHER

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2027-10-01
Completion
2027-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05584228 on ClinicalTrials.gov