NCT05584228

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Apr 2023

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Apr 2023Oct 2027

First Submitted

Initial submission to the registry

September 26, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

October 18, 2022

Status Verified

September 1, 2022

Enrollment Period

4.5 years

First QC Date

September 26, 2022

Last Update Submit

October 14, 2022

Conditions

Crohn Disease

Keywords

Crohn's diseasestrictureresectioninfliximabazathioprine

Outcome Measures

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.

    12 months

Secondary Outcomes (18)

  • IBD (inflammatory bowel disease) -related quality of life

    1, 3, 6, 9, 18 and 24 months

  • Endoscopic remission

    6 months

  • Obstructive symptoms

    1, 3, 6, 9, 12, 18 and 24 months

  • Clinical activity

    1, 3, 6, 9, 12, 18 and 24 months

  • inflammatory biomarkers (fecal calprotectin)

    1, 6, 12, 18 and 24 months

  • +13 more secondary outcomes

Study Arms (2)

Medical treatment

EXPERIMENTAL

Combination therapy with subcutaneous infliximab and azathioprine

Drug: Azathioprine + infliximab

Surgery

ACTIVE COMPARATOR

Intestinal resection

Procedure: Intestinal resection

Interventions

Azathioprine + infliximabDRUG

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

Also known as: Imurel, Remsima
Medical treatment
Intestinal resectionPROCEDURE

Ileocolonic or small bowel resection

Surgery

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Adults under guardianship, safeguard justice or trusteeship
  • Pregnant or breastfeeding female
  • Acute bowel obstruction requiring urgent surgical intervention
  • Suspected or confirmed gastrointestinal perforation
  • Concurrent active perianal sepsis
  • Internal fistulizing disease in association with strictures
  • Colonic stenosis and/or colonic active disease at screening endoscopy
  • Contra-indication to surgery, general anesthesia, anti-TNF, thiopurines
  • Use of corticosteroids (prednisolone \> 20 mg daily or equivalent) within 4 weeks prior to visit V0
  • Treatment with any biologics within 8 weeks before visit V0
  • Presence of a stoma
  • HIV/HCV/HBV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn DiseaseConstriction, Pathologic

Interventions

AzathioprineInfliximabCT-P13

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Catherine Le Berre

CONTACT

(0)2 40 08 31 52catherine.leberre@chu-nantes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 18, 2022

Study Start

April 1, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

October 18, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share