Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease

NCT03712826 | Withdrawn

• 1 other identifier: 69HCL16_0811
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Crohn disease is an inflammatory chronic disease of the bowel the complex physiopathology of which brings in immunological, genetic and environmental factors. At present, the appeal to biotherapics anti-TNFa (infliximab and adalimumab) or anti-IL-12/23 (ustekinumab) in MC represents a major therapeutic progress at the origin of a significant improvement of the symptoms, the healing of the intestinal hurts and the quality of life. Considering the new immunological targets of these biotherapics, the investigators put the hypothesis that an immunological profile (impulsive person and\\or tissular) specific of the patients with one MC is associated with the answer to biotherapics. So, before beginning the treatment the patients expressing strongly the pro-inflammatory cytokine TNFa, would more may be answering machines in anti-TNFa and those with whom the immunological profile is very marked towards the way Th1/Th17 would more may answer favorably the ustekinumab. The identification of immunological profiles capable of predicting before treatment the answer under biotherapics could establish in MC but also in other inflammatory diseases a major step forward to guide the coverage.

Conditions

Crohn Disease

Keywords

Crohn; immunological profile; ustekinumab; anti-TNF

Outcome Measures

Primary Outcomes (1)

• Immunological profile

  Identify by cytometry of mass a predictive, blood and/or mucous immunological profile, of the answer at week 14 to a biotherapics by anti-TNFa or anti IL-12 / 23 at suffering patients of Crohn disease in relapse

  Week 14

Secondary Outcomes (3)

• Mass cytometry dosage of immunological markers week 0-week 14

  Week 14

• Clinical Remission at week 14

  Week 14

• Dosage of inflammatory markers

  week 14

Study Arms (2)

anti TNF

EXPERIMENTAL

Crohn patient with antiTNF treatment

Drug: Anti-TNF Drug

Ustekinumab

EXPERIMENTAL

Crohn disease with ustekinumab treatment

Drug: Ustekinumab

Interventions

Anti-TNF Drug DRUG

Crohn patient with antiTNF treatment

anti TNF

Ustekinumab DRUG

Crohn disease with ustekinumab treatment

Ustekinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient of more than 18 years old
• Patient presenting a MC before diagnosed according to the usual criteria
• Patient in relapse (score CDAI \> 150) for at least 1 month
• requiring Patient a treatment by anti-TNF or ustekinumab according to the indications of the AMM
• Patient compatible with the realization of endoscopic digestive biopsies
• Patient having signed a consent of participation

You may not qualify if:

• · patient with Crohn disease with a CDAI score \< 150 ·
• contraindication to anti-TNF and\\or ustekinumab ·
• contraindication to the realization of an iléocoloscopie
• ·- Patient taking anti-inflammatory drugs or antibiotics ·
• Patient presenting complications of the type intestinal sub-occlusion, fistulas or abdominal abscesses ·
• Patient having a exclusive perianal disease or having
• pregnant Women ·
• Patients having been the object of a vast intestinal resection ·
• Patient with an ileostomy or a colostomy ·
• No consent of the patient ·
• patient under legal protection ·

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

MeSH Terms

Conditions

Crohn Disease

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Gilles Boschetti, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: October 19, 2018
• Study Start: July 24, 2022
• Primary Completion: July 24, 2022
• Study Completion: July 24, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09