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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03892135
Other study ID # RECHMPL19_0171
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date December 1, 2017

Study information

Verified date March 2019
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 1, 2017
Est. primary completion date October 1, 2017
Accepts healthy volunteers No
Gender All
Age group 1 Year to 17 Years
Eligibility Inclusion criteria:

- all JIA forms

- all treatment type (NSAIDs, MTX, bDMARDs)

Exclusion criteria:

- none

Study Design


Intervention

Other:
Interviews with parents of children with juvenile idiopathic arthritis
Interviews with parents of children with juvenile idiopathic arthritis
Interviews with children with juvenile idiopathic arthritis
Interviews with children with juvenile idiopathic arthritis
Interviews with Physicians
Interviews with Physicians

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Montpellier NORDIC pharma (funding), Research department, unknowns, Strategic & innovation consulting, Paris (anthropologists)

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Interview with parents Interview with parents to learn about role of parents in the management of juvenile idiopathic arthritis in their children 1 day
Secondary Interview with children Interview with children to learn about role of children in the management of their juvenile idiopathic arthritis 1 day
Secondary Interview with physicians Interview with physicians to learn about role of physicians in the management of juvenile idiopathic arthritis 1 day
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