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

Inflammatory Bowel Diseases Clinical Trial

— ArthralgieMICI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02899871
• Other study ID #: PI2014_843_0016
• Status: Completed
• Start date: September 2014
• Est. completion date: October 2016

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthralgia
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• diagnosis of joint
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.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of joint pain	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.	1 year