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

NCT ID: NCT02899871

Last Updated: 2018-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Bowel Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

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

diagnosis of joint

Intervention Type 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.

case

aetiology of joint symptoms

diagnosis of joint

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Louis DUPAS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Amiens

Amiens, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI2014_843_0016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.