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OpenTrials
Completed

NCT Number: NCT02899871

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: ArthralgieMICI

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 14, 2016
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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