Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease : A Multicenter Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504255
• Other study ID #: 2010.630
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2015
• Last updated: July 23, 2015
• Start date: April 2011
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

Crohn disease (CD) usually evolves by surges interspersed by periods of unpredictable remission. the probability of recurrence of CD in a patient in remission is even stronger if it pre-exists endoscopic lesions of the intestinal mucosa.

The mucosal healing exploration needs the realization of an ileo-colonoscopy under general anesthesia which is an invasive procedure, restrictive and expensive, thus prohibiting its too frequent repetition. we do not currently have noninvasive and reliable markers able to predict the occurrence of thrust of CD and allow the introduction of a more suitable treatment.

Indeed, relapse prevention is the best way to avoid complications and formation of lesions that lead to the irreversible medical treatment failure and surgery.

Since during the CD, it is the immunological changes that lead to inflammation and lesions, we make the assumption that the ability of certain markers immunological to predict a relapse of CD is higher than that of other in particular inflammatory markers.

This work should help to identify the profile of patients with CD in remission but at high risk of recurrence. It will specify i) the potential new markers immunological, from the pre-clinical research, predict the onset of a recurrence of CD ; ii) the predictive interest of different inflammatory markers used in routine or during the CD evaluation ; iii) Finally, the stress and the management of stressful events in the occurrence of a relapse.

This work also will specify the evolution of different markers at the moment of thrust

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 years.

• Patient with CD previously diagnosed according to standard criteria.

• Patient remission (HBS=4) for at least 3 months and has not received corticosteroids (including budesonide) in the 3 months before.

• Patient without concomitant treatment of Crohn's disease or as stable dose (5-ASA, corticosteroids, immunosuppressants, anti-TNF) immunosuppressants (azathioprine, Purinethol, methotrexate) and / or anti-TNF and / or 5- amino salicylates (5-ASA) for at least 6 months.

• Patient who signed a consent.

• Patient affiliated to a social security scheme.

Exclusion Criteria:

• A patient with an active CD (HB score=5).

• Patient who relapsed in the previous three months before inclusion.

• Patient who received corticosteroids (including budesonide) in the 6 months prior to inclusion.

• Patients on stable dose of non-anti-TNF in the 6 months prior to inclusion.

• Patient taking nonsteroidal anti-inflammatory drugs or antibiotics.

• Patient with complications of intestinal sub-occlusion type fistulas or abdominal abscesses.

• Patient with exclusive perianal disease or a predominate perianal manifestation.

• Pregnant women (examination).

• Patient who is the subject of extensive intestinal resection (> 1 m).

• Patient with ileostomy or colostomy.

• Patient on legal protection measure or who does not have the legal capacity to consent

• Lack of signed written consent of the patient.-

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Biological:
• Biological samplings
Blood, urine and faecal sampling every 3 months

Other:
• Questionnaires
patients fill several questionnaires every month to assess stress and adaptation parameters

Locations

Country	Name	City	State
France	CHU Hôpital Hôtel Dieu - Service d'Hépato-Gastroentérologie	Clermont-ferrand
France	Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Hépato-Gastroentérologie	Pierre Benite
France	CHU Hôpital Nord - Service d'Hépato-Gastroentérologie	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between new immunological markers rate and Crohn's Disease relapse	This outcome will help us to show that regular monitoring of new immunological markers (serum markers of cytotoxicity of lymphocytes, pro- and anti-inflammatory cytokines and urinary and fecal neopterin) let us predict relapse of the disease	within 15 months	No
Secondary	Correlation between usual immunological markers rate and Crohn's Disease relapse	This outcome will help us to test the ability of inflammatory markers which are already routinely used for diagnostic purposes to predict relapse of CD. These "usual" markers are : fecal calprotectin and lactoferrin, serum ultrasensitive C-Reactive Protein (CRP) and erythrocyte sedimentation rate (ESR)) is being evaluated (serum S100A12 protein, fecal, alpha-1-glycoprotein (orosomucoid) alpha-2 globulin)	within 15 months	No