Medical Treatment Versus Surgery in Stricturing Small Bowel Crohn's Disease
ConditionCrohn Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNantes University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 70 years
Male or female
Documented small bowel CD with intestinal stricture(s) identified on CT, MRI or endoscopy, AND responsible for obstructive symptoms
CREOLE score > 2
Disqualifiers
Adults under guardianship, safeguard justice or trusteeship
Pregnant or breastfeeding female
Acute bowel obstruction requiring urgent surgical intervention
Suspected or confirmed gastrointestinal perforation
Trial design
Design model
Parallel
Treatments tested in this trial
Azathioprine + infliximab
DrugCombination therapy using 2-2.5 mg/kg oral azathioprine plus subcutaneous infliximab
Intestinal resection
Procedure/SurgeryIleocolonic or small bowel resection
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Medical treatmentExperimental treatment 1 intervention
Group B: SurgeryActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
IBD (inflammatory bowel disease) - related quality of life
Mean total inflammatory bowel disease questionnaire (IBDQ - Inflammatory Bowel Disease Questionnaire ) score. The total score ranges from 32 to 224, the higher the score the better the quality of life.
Time frame
12 monthsSecondary outcomes
1
IBD (inflammatory bowel disease) -related quality of life
Mean total inflammatory bowel disease questionnaire (IBDQ - Inflammatory Bowel Disease Questionnaire ) score. The total score ranges from 32 to 224, the higher the score the better the quality of life.
Time frame
1, 3, 6, 9, 18 and 24 months2
Endoscopic remission
Proportion of patients achieving endoscopic remission at month 6 (SES-CD \< 2 in case of medical treatment or Rutgeerts score \< i,2 in case of resection)
Time frame
6 months3
Obstructive symptoms
Mean total score of CDOS (CROHN'S DISEASE OBSTRUCTIVE SCORE ) Scale frome 0 to 6. 0 is the best outcome.
Time frame
1, 3, 6, 9, 12, 18 and 24 months4
Clinical activity
Mean total score of CDAI (CROHN'S DISEASE ACTIVITY INDEX ) Scale from 0 to 1100. 0 is the best outcome.
Time frame
1, 3, 6, 9, 12, 18 and 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nantes University Hospital
Lead sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborator
Source ClinicalTrials.gov
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