Juvenile Idiopathic ArthritisAJI-APANCT02502539
Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases
A study of Juvenile Idiopathic Arthritis, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- JIA not mastered by treatments
- Other autoimmunity or auto-inflammatory diseases
- Participation in another clinical research protocol
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Etienne MERLIN
About this study
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.
Read the detailed description
Feasibility study
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Controlled physical activity
- Keywords
- Juvenile idiopathic arthritis, Physical exercise, Pro-anti-inflammatory balance, Interleukins, miRNA, Calgranulins
- Medical subject headings
- Arthritis, Juvenile, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled physical activityProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Controlled physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: AT DAY 1
Secondary outcomes (6)
pain (VAS)
to assess slipping quality
Measured: at day 1
locomotors function (CHAQ)
to assess slipping quality
Measured: at day 1
swelling of knee
to assess slipping quality
Measured: at day 1
rate of miRNA
to assess slipping quality
Measured: at day 1
plasma level of melatonin
to assess slipping quality
Measured: at day 1
sitfness of knee
to assess slipping quality
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne MERLIN, Principal investigator, CHU ESTAING
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502539
- Sponsor's protocol ID
- CHU-0234
- Other IDs
- 2015-A00607-42
- Acronym
- AJI-APA
- Status last verified
- Jul 2016
- First submitted
- 29 May 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT02502539
- Acronym / sponsor ID
- AJI-APA / CHU-0234
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- Juvenile idiopathic arthritis, Physical exercise, Pro-anti-inflammatory balance, Interleukins, miRNA, Calgranulins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Feasibility study
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autoimmune disease | Experimental | Procedure: Controlled physical activityto identify the mechanisms through which physical activity is liable to mediate inflammatory balance in autoimmune disease settings, and specifically in JIA patients. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Infection
- Fever
- Anti-IL6 treatment
- More than 6h per week of physical activity
- Systemic corticosteroid treatment during the 3 months before starting study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled physical activity | Procedure or surgery | autoimmune disease |
Primary outcome
Percent change
Time frame: AT DAY 1
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)
6 secondary outcomes
pain (VAS)
Time frame: at day 1
locomotors function (CHAQ)
Time frame: at day 1
swelling of knee
Time frame: at day 1
rate of miRNA
Time frame: at day 1
plasma level of melatonin
Time frame: at day 1
sitfness of knee
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne MERLIN principal investigator
CHU ESTAING
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Juvenile Idiopathic Arthritis, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change (time frame: AT DAY 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.