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Crohn DiseaseSMARTNCT05584228

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

A study testing Azathioprine + infliximab and Intestinal resection in people with Crohn Disease, run by Nantes University Hospital at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Crohn Disease
What is being tested?
Azathioprine + infliximab and Intestinal resection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteFrance
Study dates
1 Oct 2026to 1 Apr 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Catherine Le Berre contact

(0)2 40 08 31 52 ext. + 33

catherine.leberre@chu-nantes.fr

France1 site

  • CHU de Nantes

    Nantes, 44093

    Catherine LE BERRE, 0240083152, catherine.leberre@chu-nantes.fr

Other trials in France

About this study

Official title: SyMptomAtic Stricturing Small Bowel CRohn's Disease - Medical Treatment Versus Surgery, a Prospective, Multi-centre, Randomized, Non-inferiority 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.

Read the detailed description

Crohn's disease (CD) is a chronic, disabling and destructive inflammatory bowel disease (IBD) leading to progressive and cumulative bowel damage, including fistulas and strictures. Strictures are defined as intestinal luminal narrowing and can lead to obstructive symptoms in the medium-to-long term. Symptomatic strictures significantly impair patient's quality of life by the presence of obstructive symptoms such as abdominal pain, nausea, vomiting, abdominal distension, and dietary restrictions leading to malnutrition. Strictures can appear anywhere in the gastrointestinal tract, but affect most commonly the terminal ileum. Epidemiological studies indicate that more than 40% of patients with ileal CD will develop strictures.

However, treatment strategies are not well-defined in this indication. Most patients undergo surgery but recent observations indicate that a medical treatment by anti-TNF may be considered in stricturing CD. The European Crohn's Colitis Organization recommends that "ileocecal CD with obstructive symptoms, but no significant evidence of active inflammation, should be treated by surgery". However, the lack of inflammation is difficult to demonstrate and does not predict the extent of fibrosis, and inflammation and fibrosis are often associated. Thus, there is a need for better defining therapeutic strategies.

The objective of the SMART trial is to compare for the first time medical versus surgical approaches in stricturing CD. Indeed, up to date, no randomized controlled trial has been conducted to compare medical treatment alone versus surgery in patients with symptomatic stricturing CD. The hypothesis is that medical treatment by a combination therapy using infliximab and azathioprine is non-inferior to surgical resection in terms of health-related quality of life (HRQoL) at 1 year, with the advantage of being conservative as regards the high rates of post-operative recurrence with the subsequent risk of small bowel syndrome, as well as highly more acceptable by patients, especially since infliximab is now available as a biosimilar in a subcutaneous formulation, which should also improve the cost-effectiveness of the medical strategy.

Conditions
Crohn Disease
Being tested
Azathioprine + infliximab, Intestinal resection
Keywords
Crohn's disease, stricture, resection, infliximab, azathioprine
Medical subject headings
Crohn Disease, Constriction, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azathioprine + infliximabDrug

    Also called Imurel, Remsima

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

  • Intestinal resectionProcedure or surgery

    Ileocolonic or small bowel resection

Study groups in NCT05584228
Study groupRoleWhat they receive
Medical treatmentExperimentalCombination therapy with subcutaneous infliximab and azathioprine
Receives: Drug: Azathioprine + infliximab
SurgeryActive comparatorIntestinal resection
Receives: Procedure: Intestinal resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (18)

  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.

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

  2. 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)

    Measured: 6 months

  3. Obstructive symptoms

    Mean total score of CDOS (CROHN'S DISEASE OBSTRUCTIVE SCORE ) Scale frome 0 to 6. 0 is the best outcome.

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

  4. Clinical activity

    Mean total score of CDAI (CROHN'S DISEASE ACTIVITY INDEX ) Scale from 0 to 1100. 0 is the best outcome.

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

  5. inflammatory biomarkers (fecal calprotectin)

    Mean values of fecal calprotectin

    Measured: 1, 6, 12, 18 and 24 months

  6. inflammatory biomarkers ( C-reactive protein [CRP])

    Mean values of CRP

    Measured: 1, 6, 12, 18 and 24 months

  7. imaging parameters

    Proportion of patients with an improvement in wall thickening, contrast enhancement, T2-signal increase, diffusion weighted-signal increase and length of pathological segment at month 12 as compared to screening imaging (MRI) by physician global assessment

    Measured: 12 months

  8. treatment failures

    Proportion of patients without any treatment failures

    Measured: 12 and 24 months

  9. patient-reported outcomes (disability)

    Mean total score of IBD-DI (INFLAMMATORY BOWEL DISEASE DISABILITY INDEX ) Score from 0 to 100. 0 is the best outcome (no disability)

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

  10. patient-reported outcomes (work productivity)

    Mean total score of WPAI (WORK PRODUCTIVITY AND ACTIVITY IMPAIRMENT QUESTIONNAIRE) In percentage from 0 to 100.

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

  11. patient-reported outcomes (fatigue)

    Mean total score of FACIT-F (Functional Assessment of Chronic Illness Therapy ) scores from 0 to 52, with higher scores corresponding to less fatigue

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

  12. patient-reported outcomes (body image)

    Mean total score of body image questionnaire Ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance

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

  13. patient-reported outcomes (generic quality-of-life)

    Mean total score of SF-36 (QUESTIONNAIRE SHORT FORM 36 HEALTH SURVEY ) Score ranging from 0 to 100. A low score reflects a perception of poor health, loss of function, presence of pain. A high score reflects a perception of good health, absence of functional deficit and pain

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

  14. patient-reported outcomes (anxiety/depression)

    Mean total score of HAD (Hospital Anxiety and Depression scale) 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus allowing two scores (maximum score for each score = 21). Minimum : 0. The best outcome is 0.

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

  15. Patient's acceptability -patients refusing to be included

    Number of screened patients refusing to be included

    Measured: 24 months

  16. patient's acceptability - The reason

    The reason for refusing

    Measured: 24 months

  17. intervention-related adverse events

    Proportion of patients with intervention (drug or surgery) -related adverse events during the study

    Measured: 24 months

  18. efficiency of medical treatment compared to surgery as assessed by a cost-utility analysis performed from a collective perspective

    Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a collective perspective

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2022
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Apr 2030 (estimated)
  4. Study completion1 Apr 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05584228
Sponsor's protocol ID
RC22_0408
Acronym
SMART
Status last verified
Jun 2026
First submitted
26 Sep 2022
Last updated
23 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Azathioprine + infliximab and Intestinal resection in people with Crohn Disease, run by Nantes University Hospital at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Catherine Le Berre ((0)2 40 08 31 52 ext. + 33, catherine.leberre@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IBD (inflammatory bowel disease) - related quality of life (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05584228.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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