Infliximab Blood Test in Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT03964883|
Recruitment Status : Completed
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
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|
|Study Type :||Observational|
|Actual Enrollment :||72 participants|
|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|
- 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.
- 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
- 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.
- 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.
- 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.
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
|Groupe Hospitalier Paris Saint Joseph|
|Principal Investigator:||Nadia Fathallah||Groupe Hospitalier Paris Saint Joseph|