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Infliximab Blood Test in Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964883
Recruitment Status : Completed
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

Ano-perineal lesions are the first signs of Crohn's disease in 1/3 to 1/2 of cases. They are most often associated with a poor prognosis of the disease and their management is complex and difficult because of the dilapidated and recurrent nature of lesions with significant repercussions on continence and quality of life.

The treatment of these lesions is most often medical and surgical, consisting of drainage of the suppurative lesions and/or the use of biotherapy +/- combined with an immunosuppressant.


Condition or disease
Crohn Disease

Detailed Description:
Pharmacological dosages of biotherapies show a significant correlation between the highest rates and the achievement of clinical and endoscopic remission. Therapeutic monitoring by dosing the residual levels of these biotherapies and specific antibodies, particularly in the event of loss of response in order to adapt the treatment, has become common for luminal damage. Among these biotherapies, infliximab is the first-line treatment, particularly for ano-perineal disease. Effective therapeutic levels are known for luminal damage and must be between 3 and 7 mcg/ml but these levels have not yet been determined for ano-perineal damage. There are only two recently published studies available that suggest levels probably significantly higher than those required for luminal damage ≥ 10 mcg/l

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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Infliximab Blood Test in Crohn's Disease
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease




Primary Outcome Measures :
  1. Identify doses and residual levels of infliximab in patients affected by ano-perineal Crohn's disease in remission [ Time Frame: Time of inclusion ]
    doses and residual levels of infliximab in remission patients will be collected to determine minimum, maximum and average values.


Secondary Outcome Measures :
  1. Compare doses and residual rates of infliximab in patients affected by Crohn's disease in remission with luminal impairment alone versus ano-perineal +/- luminal [ Time Frame: Time of inclusion ]
    Doses and infliximab's residual levels will be collected from patients affected by Crohn's disease in remission with luminal alone and from patients in remission with ano-perineal +/- luminal for comparison

  2. Evaluate the proportion of patients in luminal remission with active ano-perineal disease [ Time Frame: Time of inclusion ]
    Calculation of patient's proportion with active ano-perineal disease on total of all patients in luminal remission.

  3. Compare residual doses and infliximab levels in patients with ano-perineal disease in remission versus active [ Time Frame: Time of inclusion ]
    Infliximab doses, infliximab residual levels will be collected from patients affected by Crohn's disease with ano-perineal involvement to compare remission patients and patients with active disease.

  4. Anti-infliximab antibodies presence (yes/no) in patients with ano-perineal disease in remission versus active [ Time Frame: Time of inclusion ]
    Anti-infliximab antibodies will be collected from patients affected by Crohn's disease with ano-perineal involvement to compare remission patients and patients with active disease.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed for Crohn's disease and treated with Infliximab
Criteria

Inclusion Criteria:

  • All patients followed for Chron's diseases within Groupe Hospitalier Paris Saint-Joseph (GHPSJ) and treated with Infliximab for at least 6 months.

Exclusion Criteria:

  • All patients with therapeutic compliance problems

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): NCT03964883


Locations
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France
Groupe Hospitalier Paris Saint Joseph
Paris, France
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Nadia Fathallah Groupe Hospitalier Paris Saint Joseph
Publications of Results:
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03964883    
Other Study ID Numbers: LAP CROHN INFLIXIMAB
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases