Juvenile Idiopathic ArthritisRUMAJINCT03892135
Representation and Medication Use in Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
According to the International League of Associations for Rheumatology classification, Juvenile Idiopathic Arthritis (JIA) comprises a heterogeneous group of arthritis of unknown cause and with onset before 16 years of age, characterized by joint inflammation lasting for 6 or more weeks. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Interviews with parents of children with juvenile idiopathic arthritis, Interviews with children with juvenile idiopathic arthritis and Interviews with Physicians
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2017to 1 Dec 2017
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with JIA and their parents
Who may be able to join
- all JIA forms
- all treatment type (NSAIDs, MTX, bDMARDs)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Representation and Medication Use in Juvenile Idiopathic Arthritis - RUMAJI
According to the International League of Associations for Rheumatology classification, Juvenile Idiopathic Arthritis (JIA) comprises a heterogeneous group of arthritis of unknown cause and with onset before 16 years of age, characterized by joint inflammation lasting for 6 or more weeks. Few studies exist regarding the care experience of children affected by this rheumatic condition. On the other hand, methotrexate and biologics constitute the primary treatment for children with JIA. As with adults undergoing the same treatment, adherence is critical. Difficulties for children to take the drugs have been reported. Notwithstanding, if adherence promotion in pediatric chronic conditions has been the subject of recommendations with regard to care management, the investigators lack information to understand the grounds for adherence specifically in JIA. In order to understand and decipher the parent-child adherence mechanisms and practices, the RUMAJI study will be conducted. Indeed, improving the relational approach between children and their caregivers as well as unrestricted drug adherence involves researching and understanding how appropriation of the disease and treatment could be achieved.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Interviews with parents of children with juvenile idiopathic arthritis, Interviews with children with juvenile idiopathic arthritis, Interviews with Physicians
- Keywords
- Role of parents, children and physician, Qualitative, Interview, Juvenile idiopathic arthritis, Adherence, mechanisms of adherence in juvenile idiopathic arthritis
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews with parents of children with juvenile idiopathic arthritisOther
Interviews with parents of children with juvenile idiopathic arthritis
Interviews with children with juvenile idiopathic arthritisOther
Interviews with children with juvenile idiopathic arthritis
Interviews with PhysiciansOther
Interviews with Physicians
| Study group | Role | What they receive |
|---|---|---|
| Physicians | 3 paediatricians and 3 rheumatologists Receives: Other: Interviews with Physicians | |
| Parents | Parents Receives: Other: Interviews with parents of children with juvenile idiopathic arthritis | |
| Children | Children Receives: Other: Interviews with children with juvenile idiopathic arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview with parents
Interview with parents to learn about role of parents in the management of juvenile idiopathic arthritis in their children
Measured: 1 day
Secondary outcomes (2)
Interview with children
Interview with children to learn about role of children in the management of their juvenile idiopathic arthritis
Measured: 1 day
Interview with physicians
Interview with physicians to learn about role of physicians in the management of juvenile idiopathic arthritis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Apr 2017
- Primary completion1 Oct 2017
- Study completion1 Dec 2017
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.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Research department, unknowns, Strategic & innovation consulting, Paris (anthropologists), NORDIC pharma (funding)
- Responsible party
- Sponsor
- Investigators
- Jean-David COHEN, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892135
- Sponsor's protocol ID
- RECHMPL19_0171
- Acronym
- RUMAJI
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Representation and Medication Use in Juvenile Idiopathic Arthritis - RUMAJI
- ClinicalTrials.gov ID
- NCT03892135
- Acronym / sponsor ID
- RUMAJI / RECHMPL19_0171
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- Role of parents, children and physician, Qualitative, Interview, Juvenile idiopathic arthritis, Adherence, mechanisms of adherence in juvenile idiopathic arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Research department, unknowns, Strategic & innovation consulting, Paris (anthropologists), NORDIC pharma (funding)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 27 Mar 2019 (actual)
- 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.
According to the International League of Associations for Rheumatology classification, Juvenile Idiopathic Arthritis (JIA) comprises a heterogeneous group of arthritis of unknown cause and with onset before 16 years of age, characterized by joint inflammation lasting for 6 or more weeks. Few studies exist regarding the care experience of children affected by this rheumatic condition. On the other hand, methotrexate and biologics constitute the primary treatment for children with JIA. As with adults undergoing the same treatment, adherence is critical. Difficulties for children to take the drugs have been reported. Notwithstanding, if adherence promotion in pediatric chronic conditions has been the subject of recommendations with regard to care management, the investigators lack information to understand the grounds for adherence specifically in JIA. In order to understand and decipher the parent-child adherence mechanisms and practices, the RUMAJI study will be conducted. Indeed, improving the relational approach between children and their caregivers as well as unrestricted drug adherence involves researching and understanding how appropriation of the disease and treatment could be achieved.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physicians | – | Other: Interviews with Physicians3 paediatricians and 3 rheumatologists |
| Parents | – | Other: Interviews with parents of children with juvenile idiopathic arthritisParents |
| Children | – | Other: Interviews with children with juvenile idiopathic arthritisChildren |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with JIA and their parents
Key inclusion criteria (2 listed)
- all JIA forms
- all treatment type (NSAIDs, MTX, bDMARDs)
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Interviews with parents of children with juvenile idiopathic arthritisInterviews with parents of children with juvenile idiopathic arthritis | Other | Parents |
| Interviews with children with juvenile idiopathic arthritisInterviews with children with juvenile idiopathic arthritis | Other | Children |
| Interviews with PhysiciansInterviews with Physicians | Other | Physicians |
Primary outcome
Interview with parents
Time frame: 1 day
Interview with parents to learn about role of parents in the management of juvenile idiopathic arthritis in their children
2 secondary outcomes
Interview with children
Time frame: 1 day
Interview with physicians
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Individual participant dataSharing planned: Undecided. NC
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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.
Jean-David COHEN, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis, run by University Hospital, Montpellier 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 2 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: finished, as of the sponsor's last update on 29 Apr 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interview with parents (time frame: 1 day). 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 29 Apr 2019.