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

August 9, 2018 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
patients treated with anti-TNF not presenting any joint symptoms.
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.
case
aetiology of joint symptoms
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of joint pain
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Jean-Louis DUPAS, MD, PhD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2014_843_0016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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