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

NCT02899871 | Completed

• 1 other identifier: PI2014_843_0016
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

joint pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control

patients treated with anti-TNF not presenting any joint symptoms.

Other: diagnosis of joint

case

aetiology of joint symptoms

Other: diagnosis of joint

Interventions

diagnosis of joint OTHER

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.

Control; case

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 with IBD (Crohn's disease or ulcerative colitis),

You may qualify if:

• 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.

You may not qualify if:

• Protected majors (under permanent or temporary guardianship).

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Arthralgia

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Louis DUPAS, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 14, 2016
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

FR (1)