Joint Pain Occurring During Anti-TNF Therapy in Chronic Inflammatory Bowel Disease

Completed

• Conditions: Inflammatory Bowel Diseases
• Interventions: Other: diagnosis of joint

• Registration Number: NCT02899871
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

IBD (inflammatory bowel disease) are associated with various types of joint manifestations, especially inflammatory. Patients with IBD treated with anti-TNF commonly report joint symptoms, with variable expressions and aetiologies, possibly responsible for impaired quality of life, and possibly leading to discontinuation of an effective and validated treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2016-09
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-14
• Study Completion: 2016-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Males or females over the age of 18 years at the time of inclusion
• Patients with IBD (Crohn's disease or ulcerative colitis), diagnosed by a set of compatible clinical (chronic diarrhoea, haematochezia, anoperineal lesions, etc.), laboratory, histological and endoscopic arguments. Patients will be included regardless of the severity of their disease, its clinical course, the type of lesions, and the presence or absence of associated manifestations.
• Patients treated with anti-TNF: infliximab or adalimumab.
• Informed patients not refusing to participate.
• Patients covered by French national health insurance.

Exclusion Criteria

• Patients under the age of 18 years at the time of inclusion.
• Patients previously treated with anti-TNF, but no longer treated with anti-TNF at the time of inclusion.
• Protected majors (under permanent or temporary guardianship).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
case	diagnosis of joint	aetiology of joint symptoms
Control	diagnosis of joint	patients treated with anti-TNF not presenting any joint symptoms.

Primary Outcome Measures

Name	Time	Method
Diagnosis of joint pain	1 year	presence or absence : The diagnosis of joint pain will be established by a rheumatologist and completed: * If necessary, by a clinically guided radiological assessment (plain x-rays, joint ultrasound, bone and joint MRI).; * serum assays of the anti-TNF administered, as well as screening for associated antibodies.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France