An observational study in Crohn Disease, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-28.
Sponsored by Fondation Hôpital Saint-Joseph · Observational
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.
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
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 72 is below the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients followed for Crohn's disease and treated with Infliximab
Exclusion Criteria:
Identify doses and residual levels of infliximab in patients affected by ano-perineal Crohn's disease in remission
doses and residual levels of infliximab in remission patients will be collected to determine minimum, maximum and average values.
Time frame: Time of inclusion
Compare doses and residual rates of infliximab in patients affected by Crohn's disease in remission with luminal impairment alone versus ano-perineal +/- luminal
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
Time frame: Time of inclusion
Evaluate the proportion of patients in luminal remission with active ano-perineal disease
Calculation of patient's proportion with active ano-perineal disease on total of all patients in luminal remission.
Time frame: Time of inclusion
Compare residual doses and infliximab levels in patients with ano-perineal disease in remission versus active
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.
Time frame: Time of inclusion
Anti-infliximab antibodies presence (yes/no) in patients with ano-perineal disease in remission versus active
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.
Time frame: Time of inclusion
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Fondation Hôpital Saint-Joseph