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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Recurrent Multifocal Osteomyelitis
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Service Rhumatologie Pédiatrique Centre De Référence Maladies Rares RAISE Hôpital Femme Mère Enfant
  • Lyon, France, 69003
    • Service de Rhumatologie Centre Hospitalier Edouard Herriot
  • Pierre-Bénite, France, 69310
    • Service de Rhumatologie Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 8, 2020
• Primary Completion (ACTUAL): November 10, 2020
• Study Completion (ACTUAL): November 10, 2020

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (ACTUAL): November 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Infectious; Recurrence; Osteitis; Osteomyelitis
• Other Study ID Numbers: 69HCL20_0481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No