NCT02502539

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

1.3 years

First QC Date

May 29, 2015

Last Update Submit

July 25, 2016

Conditions

Juvenile Idiopathic Arthritis

Keywords

Juvenile idiopathic arthritisPhysical exercisePro-anti-inflammatory balanceInterleukinsmiRNACalgranulins

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • pain (VAS)

    at day 1

  • locomotors function (CHAQ)

    at day 1

  • swelling of knee

    at day 1

  • rate of miRNA

    at day 1

  • plasma level of melatonin

    at day 1

  • +1 more secondary outcomes

Study Arms (1)

autoimmune disease

EXPERIMENTAL

to identify the mechanisms through which physical activity is liable to mediate inflammatory balance in autoimmune disease settings, and specifically in JIA patients.

Procedure: Controlled physical activity

Interventions

Controlled physical activityPROCEDURE
autoimmune disease

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Arthritis, JuvenileMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Etienne MERLIN

    CHU ESTAING

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2015

First Posted

July 20, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2016

Study Completion

January 1, 2017

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

FR(1)