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Predictive Factors of Clinical Response to Ustekinumab in Active Crohn's Disease (SAFARI)

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ClinicalTrials.gov Identifier: NCT03351647
Recruitment Status : Unknown
Verified February 2018 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : November 24, 2017
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

Ustekinumab is a fully human Immune Globulin Gk (IgGk) monoclonal antibody against the common p40 subunit of interleukin-12 and interleukin-23, which are implicated in the pathogenesis of inflammatory bowel disease. Its efficiency to induce and maintain clinical response in patients with anti TNF resistant Crohn's disease has been proved in several clinical trials, and the profile of safety of this treatment was good, but the investigators have few data about biological characteristics of patients treated by Ustekinumab, particularly about ustekinumab through levels and rate of patients developing anti ustekinumab antibodies during the induction and maintenance stages, and no predictive factors of clinical response have been identified yet.

The aim of this study will be to assess the evolution of biological markers of inflammation and ustekinumab trough levels and antibodies, in responders and non responders patients treated by ustekinumab, in order to identify predictive factors of clinical response.

The investigators will perform a prospective observational study, including the patients followed in the University hospital center of Lyon and treated by ustekinumab for a moderate to severe Crohn's disease (with a HBI score≥4 ). All the patients included will have been previously treated by at least one anti TNF and/or Vedolizumab, with specified criteria for a primary non response, a secondary loss of response or unacceptable side effects.

Then, clinical and biological data will be collected for each patient at the inclusion, and then at weeks 4, 8, 16, 24: HBI score, sides effects, extra intestinal manifestations, steroids withdraw, CRP, calprotectin, ustekinumab trough levels and ustekinumab antibodies.

The investigators will compare responding and non responding patients at week 16 (end of the induction period) according to these data.

The hypothesis the investigators state is that an early and significant decrease of the inflammation markers in blood and stools associated with a high ustekinumab through level in blood is associated with a clinical response at week 16 in the patients treated by ustekinumab


Condition or disease Intervention/treatment
Crohn Disease Biological: Evaluation of biological predictive factors of clinical response to ustekinumab

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Biological Predictive Factors of Clinical Response to Ustekinumab in Patients With Anti-Tumor Necrosis Factor (TNF) Antagonists Refractory Crohn's Disease: Interest of Dosage of C Reactive Protein (CRP), Calprotectin, Ustekinumab Through Levels and Antibodies
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Ustekinumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
Group Ustekinumab
Patients presenting an active crohn's disease (HBI score ≥ 4) with an indication of treatment by ustekinumab because of failure or unacceptable side effects of previous treatments, and who have already been treated by at least one anti TNF The patients must be 18 years old or older.
 Biological: Evaluation of biological predictive factors of clinical response to ustekinumab
The clinical response is defined as a decrease in the Crohn's Disease Activity Index (CDAI) score ≥ 100 points or a decrease in the HBI score ≥ 3 points.


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of serum ustekinumab trough concentrations (expressed in microg/mL) at week 8. [ Time Frame: Week 8 ]
    Dosage of ustekinumab through level and ustekinumab antibodies: one 4ml blood sample


Secondary Outcome Measures :
  1. Measurement of serum ustekinumab trough concentrations (expressed in microg/mL) at week 4. [ Time Frame: Week 4 ]
    Dosage of ustekinumab through level and ustekinumab antibodies: one 4ml blood sample

  2. Measurement of serum ustekinumab trough concentrations (expressed in microg/mL) at week 16. [ Time Frame: Week 16 ]
    Dosage of ustekinumab through level and ustekinumab antibodies: one 4ml blood sample

  3. Measurement of serum ustekinumab trough concentrations (expressed in microg/mL) at week 24. [ Time Frame: Week 24 ]
    Dosage of ustekinumab through level and ustekinumab antibodies: one 4ml blood sample

  4. Dosage in blood at week 4 [ Time Frame: Week 4 ]
    -Inflammation markers are evaluated : Dosage of CRP and leucocytes in blood: two 4ml blood sample

  5. Dosage in blood at week 8 [ Time Frame: Week 8 ]
    -Inflammation markers are evaluated : Dosage of CRP and leucocytes in blood: two 4ml blood sample

  6. Dosage in blood at week 16 [ Time Frame: Week 16 ]
    -Inflammation markers are evaluated : Dosage of CRP and leucocytes in blood: two 4ml blood sample

  7. Dosage in blood at week 24 [ Time Frame: Week 24 ]
    -Inflammation markers are evaluated : Dosage of CRP and leucocytes in blood: two 4ml blood sample

  8. Dosage of calprotectin in stools at week 4 [ Time Frame: Week 4 ]
    -Inflammation markers are evaluated : Dosage of calprotectin in stools: one about 50 mg stools sample

  9. Dosage of calprotectin in stools at week 8 [ Time Frame: Week 8 ]
    -Inflammation markers are evaluated : Dosage of calprotectin in stools: one about 50 mg stools sample

  10. Dosage of calprotectin in stools at week 16 [ Time Frame: Week 16 ]
    -Inflammation markers are evaluated : Dosage of calprotectin in stools: one about 50 mg stools sample

  11. Dosage of calprotectin in stools at week 24 [ Time Frame: Week 24 ]
    -Inflammation markers are evaluated : Dosage of calprotectin in stools: one about 50 mg stools sample

  12. Physical evaluation at week 4 [ Time Frame: Week 4 ]
    Clinical evaluation is realized by a medical visit with physical examination

  13. Physical evaluation at week 8 [ Time Frame: Week 8 ]
    Clinical evaluation is realized by a medical visit with physical examination

  14. Physical evaluation at week 16 [ Time Frame: Week 16 ]
    Clinical evaluation is realized by a medical visit with physical examination

  15. Physical evaluation at week 24 [ Time Frame: Week 24 ]
    Clinical evaluation is realized by a medical visit with physical examination

  16. Clinical evaluation at week 4 [ Time Frame: Week 4 ]

    Clinical evaluation is realized by a medical visit with evaluation of:

    • the efficiency of the treatment: evaluation of well being, abdominal pain, stools numbers per day, presence or not of peri anal lesion, arthralgia, fever
    • the tolerance/potential side effects of the treatment: infections, headache, skin rash, nausea, allergic reaction, or any clinical manifestation that could be imputed to the treatment

  17. Clinical evaluation at week 8 [ Time Frame: Week 8 ]

    Clinical evaluation is realized by a medical visit with evaluation of:

    • the efficiency of the treatment: evaluation of well being, abdominal pain, stools numbers per day, presence or not of peri anal lesion, arthralgia, fever
    • the tolerance/potential side effects of the treatment: infections, headache, skin rash, nausea, allergic reaction, or any clinical manifestation that could be imputed to the treatment

  18. Clinical evaluation at week 16 [ Time Frame: Week 16 ]

    Clinical evaluation is realized by a medical visit with evaluation of:

    • the efficiency of the treatment: evaluation of well being, abdominal pain, stools numbers per day, presence or not of peri anal lesion, arthralgia, fever
    • the tolerance/potential side effects of the treatment: infections, headache, skin rash, nausea, allergic reaction, or any clinical manifestation that could be imputed to the treatment

  19. Clinical evaluation at week 24 [ Time Frame: Week 24 ]

    Clinical evaluation is realized by a medical visit with evaluation of:

    • the efficiency of the treatment: evaluation of well being, abdominal pain, stools numbers per day, presence or not of peri anal lesion, arthralgia, fever
    • the tolerance/potential side effects of the treatment: infections, headache, skin rash, nausea, allergic reaction, or any clinical manifestation that could be imputed to the treatment


Biospecimen Retention:   Samples Without DNA
Three blood samples of 4 ml, one stool sample of 50 mg

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 18 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study is conducted in adults with moderate to severe active Crohn's disease who are resistant to TNF and Vedolizumab.
Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Man or non pregnant woman
  • Diagnostic attested of Crohn's disease
  • Active Crohn's disease, with HBI score ≥ 4
  • Previous treatment by at least one anti TNF and / or vedolizumab,, with primary non response, secondary loss of response or unacceptable side effects
  • Formal indication of treatment by ustekinumab
  • Patient informed and not opposed to his participation at the study

Exclusion Criteria:

  • Pregnancy
  • Evolutive cancer
  • Evolutive and uncontrolled infection
  • Psychiatric pathology that could interfere with the follow-up
  • Refusal of the patient
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351647


Contacts
Layout table for location contacts
Contact: Stéphane NANCEY, MD 04 78 86 12 89 ext +33 stephane.nancey@chu-lyon.fr
Contact: Ninon SOUFFLET 06 87 35 64 16 ext +33 ninon.soufflet@gmail.com

Locations
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France
Centre hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69495
Contact: Stéphane NANCEY, MD    04 78 86 12 89 ext +33    stephane.nancey@chu-lyon.fr   
Principal Investigator: Stéphane NANCEY, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03351647    
Other Study ID Numbers: 69HCL17_0218
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Crohn Disease
Ustekinumab
Vedolizumab
anti-TNF
 CRP
calprotectin
cohort
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Intestinal Diseases
Ustekinumab
Dermatologic Agents