NCT03964883

Infliximab Blood Test in Crohn's Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: Fondation Hôpital Saint-Joseph · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Crohn Disease

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-03-01
• Completion: 2018-03-31
• First posted: 2019-05-28
• Last updated: 2019-05-28

Locations

1 site across 1 country: France