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

NCT05103137 | Completed

• 1 other identifier: 69HCL20_0481
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Chronic Recurrent Multifocal Osteomyelitis

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Questionnaire OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with CRMO disease started at pediatric age. Patients who agreed to participate to the study (study questionnaires during a telephone interview (SF36, HAQ and questionnaire pre-established for the study)

You may qualify if:

• Adult Patient with a CRMO with pediatric-onset disease (\> 18years)
• Patient who was informed and agreed to participate in this study

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Service Rhumatologie Pédiatrique Centre De Référence Maladies Rares RAISE Hôpital Femme Mère Enfant

Bron, 69500, France

Location

Service de Rhumatologie Centre Hospitalier Edouard Herriot

Lyon, 69003, France

Location

Service de Rhumatologie Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Chronic recurrent multifocal osteomyelitis

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: October 8, 2020
• Primary Completion: November 10, 2020
• Study Completion: November 10, 2020
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)