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Juvenile Idiopathic ArthritisRHUMEDOLNCT03740347

Chronic Non-inflammatory Pains in Rheumatopediatrics

An observational study of Juvenile Idiopathic Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to determine the frequency of chronic pain in adolescent with juvenile idiopathic arthritis, especially when the disease is inactive or with minimal activity. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Juvenile Idiopathic Arthritis
What is being tested?
Questionnaires
How many people
0 participants
Where
1 siteFrance
Study dates
6 Nov 2018to 6 Nov 2018
Phase
Observational
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 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Patients over 12 years of age followed for juvenile idiopathic arthritis in the reference center at Necker-Enfants malades Hospital (RAISE)

Who may be able to join

  • Child from 12 to 17 years old
  • Follow-up to Necker Hospital by a rheumatologist at the reference center for juvenile idiopathic arthritis (RAISE), regardless of the form
  • Not opposed to participating in the study

Who cannot join

  • No exclusion criteria

Trial locations and contacts

1 site in 1 country.

France1 site

  • Functional Unit of "Pain and Palliative Medicine"- Necker-Enfants malades Hospital

    Paris, 75015

Other trials in France

About this study

The purpose of this study is to determine the frequency of chronic pain in adolescent with juvenile idiopathic arthritis, especially when the disease is inactive or with minimal activity.

Secondary objectives are, first to determine intensity of pain and its repercussion in daily life and second to determine risk factor of chronic pain.

Read the detailed description

Juvenile idiopathic arthritis is the most frequent pathology in paediatric rheumatology clinic. Pain is an important symptom in paediatric rheumatology. It is actually poorly studied and is not evaluate in disease activity score like the Juvenile Arthritis Disease Activity Score (JADAS). It is source of handicap, social and psychological distress and greatly contribute to poor quality of life. Chronic pain is frequently multifactorial, even in inflammatory disease. In adult population, rheumatologists have shown an association between inflammatory disease like spondylarthritis or rheumatology polyarthritis and fibromyalgia.

There is no specific data on chronic pain in juvenile idiopathic arthritis. Pain is mostly evaluated by the Visual Analogue Scale (VAS) with no evaluation of pain repercussion on daily life or its chronicity. This study's primary objective is to determine the frequency of chronic pain and its relationship with disease activity. Secondaries objectives are to determine repercussion of pain in daily life, and risk factor of chronic pain.

To responded to this objective, we will conduct a transversal study in a paediatric rheumatology refence centre in Necker-Enfants malades Hospital. We will include all patients between 12 and 18 years old followed in our centre for any type of juvenile idiopathic arthritis.

Patients will be evaluated as usual by their paediatrics rheumatologist during a follow-up consultation or hospitalisation with the used of the clinical JADAS. Patient accepting to participate the study will be given a paper questionnaire evaluating chronic pain, its repercussion, anxiety (by the used of the Revised Children's Manifest Anxiety Scale (RCMAS score)), depression (by the used of the Children's Depression Inventory (CDI score)), Sleepiness (by the used of the Pediatric Daytime Sleepiness Scale (PDSS score)) and quality of life (by the used of the measurement model for the Pediatric Quality of Life inventory (PedQL score)).

Being tested
Questionnaires
Keywords
Juvenile idiopathic arthritis, chronic pain, anxiety, depression, sleepiness, quality of life
Medical subject headings
Arthritis, Juvenile, Chronic Pain, Anxiety Disorders, Depression, Sleepiness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnairesBehavioural

    Also called Evaluation of the chronic pain repercussion in juvenile idiopathic arthritis

    Response to questionnaires evaluating chronic pain and its repercussion :

    • anxiety questionnaire (Revised Children's Manifest Anxiety Scale),
    • depression questionnaire (Children's Depression Inventory score),
    • sleepiness questionnaire (Pediatric Daytime Sleepiness Scale),
    • quality of life questionnaire (Pediatric Quality of Life inventory score).
Study groups in NCT03740347
Study groupRoleWhat they receive
Juvenile idiopathic arthritis and chronic painPatients followed for juvenile idiopathic arthritis and chronic pain in Necker Hospital
Receives: Behavioral: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of chronic pain and its relationship with disease activity

    Chronic pain will be defined by the presence of recurrent or permanent moderate pain (Visual Analogue Scale (VAS) > 3 / 10), present more than 3 days a week.

    Disease activity will be evaluated by the clinical Juvenile Arthritis Disease Activity Score (JADAS) and the definition of three groups: inactive disease, minimal disease activity and active disease.

    Measured: Day 0

Secondary outcomes (5)

  1. Chronic pain and disease repercussions

    Chronic pain and disease repercussion will be assessed by a paper questionnaire evaluation repercussion on scholarship, sports, sleep and social interaction.

    Measured: Day 0

  2. Repercussions of pain on patient anxiety

    Anxiety symptoms will be assessed with the Revised Children's Manifest Anxiety Scale (RCMAS) questionnaire

    Measured: Day 0

  3. Repercussions of pain on depression symptoms

    Depression symptoms will be assessed with the Children's Depression Inventory (CDI) questionnaire

    Measured: Day 0

  4. Repercussions of pain on quality of life

    Anxiety symptoms will be assessed with the Pediatric Quality of Life inventory (PedQL) questionnaire

    Measured: Day 0

  5. Repercussions of pain on patient daytime sleepiness

    Anxiety symptoms will be assessed with the Pediatric Daytime Sleepiness Scale (PDSS score)

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2018
  2. Study start6 Nov 2018
  3. Primary completion6 Nov 2018
  4. Study completion6 Nov 2018

Why it stopped: Withdrawn study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03740347
Sponsor's protocol ID
APHP180230
Other IDs
2018-A02317-48
Acronym
RHUMEDOL
Status last verified
Mar 2026
First submitted
2 Nov 2018
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007 Mar 3;369(9563):767-778. doi: 10.1016/S0140-6736(07)60363-8.

    PubMed 17336654

  • Consolaro A, Ravelli A. Paediatric rheumatology: Juvenile idiopathic arthritis--are biologic agents effective for pain? Nat Rev Rheumatol. 2013 Aug;9(8):447-8. doi: 10.1038/nrrheum.2013.108. Epub 2013 Jul 2.

    PubMed 23820859

  • Tupper SM, Rosenberg AM, Pahwa P, Stinson JN. Pain intensity variability and its relationship with quality of life in youths with juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2013 Apr;65(4):563-70. doi: 10.1002/acr.21850.

    PubMed 22972759

  • Lalloo C, Stinson JN. Assessment and treatment of pain in children and adolescents. Best Pract Res Clin Rheumatol. 2014 Apr;28(2):315-30. doi: 10.1016/j.berh.2014.05.003.

    PubMed 24974065

  • Duffield SJ, Miller N, Zhao S, Goodson NJ. Concomitant fibromyalgia complicating chronic inflammatory arthritis: a systematic review and meta-analysis. Rheumatology (Oxford). 2018 Aug 1;57(8):1453-1460. doi: 10.1093/rheumatology/key112.

    PubMed 29788461

  • McErlane F, Beresford MW, Baildam EM, Chieng SE, Davidson JE, Foster HE, Gardner-Medwin J, Lunt M, Wedderburn LR, Thomson W, Hyrich KL; Childhood Arthritis Prospective Study (CAPS). Validity of a three-variable Juvenile Arthritis Disease Activity Score in children with new-onset juvenile idiopathic arthritis. Ann Rheum Dis. 2013 Dec;72(12):1983-8. doi: 10.1136/annrheumdis-2012-202031. Epub 2012 Dec 20.

    PubMed 23256951

  • Reynolds CR. Concurrent validity of "What I think and feel:" the Revised Children's Manifest Anxiety Scale. J Consult Clin Psychol. 1980 Dec;48(6):774-5. doi: 10.1037//0022-006x.48.6.774. No abstract available.

    PubMed 7440835

  • Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.

    PubMed 4089116

  • Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003.

    PubMed 10024117

  • Drake C, Nickel C, Burduvali E, Roth T, Jefferson C, Pietro B. The pediatric daytime sleepiness scale (PDSS): sleep habits and school outcomes in middle-school children. Sleep. 2003 Jun 15;26(4):455-8.

    PubMed 12841372

Questions about this trial

What is this clinical trial studying?

An observational study of Juvenile Idiopathic Arthritis, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 3 Apr 2026. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of chronic pain and its relationship with disease activity (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03740347, which also lists 10 linked publications.

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 3 Apr 2026.

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