Clinical trial NCT03964883: Infliximab Blood Test in Crohn's Disease
Official title: Infliximab Blood Test in Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed for Crohn's disease and treated with Infliximab

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.

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

Eligibility 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

Primary outcomes:
measure: Identify doses and residual levels of infliximab in patients affected by ano-perineal Crohn's disease in remission
timeFrame: Time of inclusion
Secondary outcomes:
measure: Compare doses and residual rates of infliximab in patients affected by Crohn's disease in remission with luminal impairment alone versus ano-perineal +/- luminal
timeFrame: Time of inclusion
measure: Evaluate the proportion of patients in luminal remission with active ano-perineal disease
timeFrame: Time of inclusion
measure: Compare residual doses and infliximab levels in patients with ano-perineal disease in remission versus active
timeFrame: Time of inclusion
measure: Anti-infliximab antibodies presence (yes/no) in patients with ano-perineal disease in remission versus active
timeFrame: Time of inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Nadia Fathallah
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davidov Y, Ungar B, Bar-Yoseph H, Carter D, Haj-Natour O, Yavzori M, Chowers Y, Eliakim R, Ben-Horin S, Kopylov U. Association of Induction Infliximab Levels With Clinical Response in Perianal Crohn's Disease. J Crohns Colitis. 2017 May 1;11(5):549-555. doi: 10.1093/ecco-jcc/jjw182.
citation: Yarur AJ, Kanagala V, Stein DJ, Czul F, Quintero MA, Agrawal D, Patel A, Best K, Fox C, Idstein K, Abreu MT. Higher infliximab trough levels are associated with perianal fistula healing in patients with Crohn's disease. Aliment Pharmacol Ther. 2017 Apr;45(7):933-940. doi: 10.1111/apt.13970. Epub 2017 Feb 17.
citation: Mitrev N, Kariyawasam V, Leong RW. Editorial: infliximab trough cut-off for perianal Crohn's disease - another piece of the therapeutic drug monitoring-guided infliximab dosing puzzle. Aliment Pharmacol Ther. 2017 May;45(9):1279-1280. doi: 10.1111/apt.14020. No abstract available.