Infliximab Blood Test in Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Infliximab Blood Test in Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964883
• Other study ID #: LAP CROHN INFLIXIMAB
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: March 31, 2018

Study information

• Verified date: May 2019
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 31, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (3)

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. d — View 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.140 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 of inclusion
Secondary	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 of inclusion
Secondary	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 of inclusion
Secondary	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 of inclusion
Secondary	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 of inclusion