Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases

Juvenile Idiopathic Arthritis Clinical Trial

— AJI-APA  

Official title:

Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02502539
• Other study ID #: CHU-0234
• Secondary ID: 2015-A00607-42
• Status: Recruiting
• Phase: N/A
• First received: May 29, 2015
• Last updated: July 25, 2016
• Start date: July 2015
• Est. completion date: January 2017

Study information

• Verified date: July 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Juvenile idiopathic arthritis (JIA) is a chronic disease characterized by persistent joint inflammation. The immune system disruption that leads to overproduction of pro-inflammatory cytokines (TNF-α, IL-1, IL-6) is a cascade of events on different levels—some molecular, some cellular, and some systemic. Our objective is to identify the mechanisms through which physical activity is liable to mediate inflammatory balance in autoimmune disease settings, and specifically in JIA patients.

Description:

Feasibility study

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children between 8 and 12 years

• Tanner stage < T2

• polyarthritis, oligoarthritis and ERA sub-type of JIA

• Stable disease during 3 months before starting study

Exclusion Criteria:

• Infection

• Fever

• Anti-IL6 treatment

• More than 6h per week of physical activity

• Systemic corticosteroid treatment during the 3 months before starting study

• Systemic JIA

• JIA not mastered by treatments

• Other autoimmunity or auto-inflammatory diseases

• Participation in another clinical research protocol

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Autoimmune Diseases
• Juvenile Idiopathic Arthritis

Intervention

Procedure:
• Controlled physical activity

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change	Percent change, before and after a controlled session of physical activity session, of serum and secretion kinetics of IL-6 and its soluble receptors (sIL- 6R and sgp130)	AT DAY 1	No
Secondary	pain (VAS)	to assess slipping quality	at day 1	No
Secondary	locomotors function (CHAQ)	to assess slipping quality	at day 1	No
Secondary	swelling of knee	to assess slipping quality	at day 1	No
Secondary	rate of miRNA	to assess slipping quality	at day 1	No
Secondary	plasma level of melatonin	to assess slipping quality	at day 1	No
Secondary	sitfness of knee	to assess slipping quality	at day 1	No