Chronic Recurrent Multifocal OsteomyelitisESPERANTONCT05103137
Post-transition Clinical and Socio-professional Future in Adult Patients With Recurrent Multifocal Chronic Osteitis
An observational study of Chronic Recurrent Multifocal Osteomyelitis, run by Hospices Civils de Lyon at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Recurrent Multifocal Osteomyelitis
- What is being tested?
- Questionnaire
- How many people
- 16 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Oct 2020to 10 Nov 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Adult Patient with a CRMO with pediatric-onset disease (> 18years)
- Patient who was informed and agreed to participate in this study
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service Rhumatologie Pédiatrique Centre De Référence Maladies Rares RAISE Hôpital Femme Mère Enfant
Bron, 69500
Service de Rhumatologie Centre Hospitalier Edouard Herriot
Lyon, 69003
Service de Rhumatologie Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
About this study
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.
- Being tested
- Questionnaire
- Medical subject headings
- Chronic recurrent multifocal osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaires concerning assesment of quality of life with 3 different questionnaires ( SF36, HAQ and pre-established questionnaire for the study) during a phone interview
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start8 Oct 2020
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Recurrent Multifocal OsteomyelitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103137
- Sponsor's protocol ID
- 69HCL20_0481
- Acronym
- ESPERANTO
- Status last verified
- Nov 2021
- First submitted
- 21 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-transition Clinical and Socio-professional Future in Adult Patients With Recurrent Multifocal Chronic Osteitis
- ClinicalTrials.gov ID
- NCT05103137
- Acronym / sponsor ID
- ESPERANTO / 69HCL20_0481
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 2 Nov 2021 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- Adult Patient with a CRMO with pediatric-onset disease (> 18years)
- Patient who was informed and agreed to participate in this study
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| QuestionnaireQuestionnaires concerning assesment of quality of life with 3 different questionnaires ( SF36, HAQ and pre-established questionnaire for the study) during a phone interview | Other | – |
Primary outcome
Impact of the disease on the quality of life of adult CRMO patients with pediatric-onset disease.
Time frame: 20 minutes
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
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 10 Nov 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Recurrent Multifocal Osteomyelitis, run by Hospices Civils de Lyon at 3 sites 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 5 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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Impact of the disease on the quality of life of adult CRMO patients with pediatric-onset disease. (time frame: 20 minutes). 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 10 Nov 2021.