Post-transition Clinical and Socio-professional Future in Adult Patients With Recurrent Multifocal Chronic Osteitis

Chronic Recurrent Multifocal Osteomyelitis Clinical Trial

— ESPERANTO  

Official title:

Post-transition Clinical and Socio-professional Future in Adult Patients With Recurrent Multifocal Chronic Osteitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05103137
• Other study ID #: 69HCL20_0481
• Status: Completed
• Start date: October 8, 2020
• Est. completion date: November 10, 2020

Study information

• Verified date: November 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic Recurrent Multifocal Osteomyelitis (CRMO) is a rare autoinflammatory bone disease in children. Studies evaluating the quality of life of patients with CRMO are small and heterogeneous. A better understanding of the impact of the disease on the quality of life of adult patients with CRMO beginning in childhood would allow better long-term management of these patients. Our study aims are to assess the clinical and socio-professional outcomes of adult patients who started CRMO at pediatric age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 10, 2020
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult Patient with a CRMO with pediatric-onset disease (> 18years)

• Patient who was informed and agreed to participate in this study

Exclusion Criteria:

• Patients with Monogenic auto-inflammatory disease associated with osteolytic bone lesions (e.g. interleukin-1 receptor antagonist deficiency)

• Patient with Majeed syndrome

• Patient without sufficient imaging data to confirm the presence of one or more inflammatory lesions

• Patients with incomplete data.

• Patients placed under legal protection, guardianship or curatorship

Related Conditions & MeSH terms

• Chronic Recurrent Multifocal Osteomyelitis
• Osteitis
• Osteomyelitis

Intervention

Other:
• Questionnaire
Questionnaires concerning assesment of quality of life with 3 different questionnaires ( SF36, HAQ and pre-established questionnaire for the study) during a phone interview

Locations

Country	Name	City	State
France	Service Rhumatologie Pédiatrique Centre De Référence Maladies Rares RAISE Hôpital Femme Mère Enfant	Bron
France	Service de Rhumatologie Centre Hospitalier Edouard Herriot	Lyon
France	Service de Rhumatologie Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of the disease on the quality of life of adult CRMO patients with pediatric-onset disease.	Result of the SF 36 (Short Form 36) quality of life questionnaire compared to data in the general population and other published data available in CRMO and inflammatory diseases in children.; This questionnaire is composed of 36 questions which allow to calculate two scores of the quality of life of individuals: the physical composite score (SCP) and the mental composite score (SCM). The higher the score the higher the capacity.; Range 0 to 100	20 minutes