Infliximab Blood Test in Crohn's Disease

NCT03964883 | Completed

• 1 other identifier: LAP CROHN INFLIXIMAB
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 of inclusion

• Evaluate the proportion of patients in luminal remission with active ano-perineal disease

  Time of inclusion

• Compare residual doses and infliximab levels in patients with ano-perineal disease in remission versus active

  Time of inclusion

• Anti-infliximab antibodies presence (yes/no) in patients with ano-perineal disease in remission versus active

  Time of inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed for Crohn's disease and treated with Infliximab

You may qualify if:

• All patients followed for Chron's diseases within Groupe Hospitalier Paris Saint-Joseph (GHPSJ) and treated with Infliximab for at least 6 months.

You may not qualify if:

• All patients with therapeutic compliance problems

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, France

Location

Related 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. doi: 10.1093/ecco-jcc/jjw182.

  PMID: 28453755 RESULT

• 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.

  PMID: 28211593 RESULT

• 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.

  PMID: 28370040 RESULT

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Nadia Fathallah

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 28, 2019
• Study Start: January 1, 2018
• Primary Completion: March 1, 2018
• Study Completion: March 31, 2018
• Last Updated: May 28, 2019

Record last verified: 2019-05

Locations

FR (1)