SAPHO SyndromeNCT01688219
Immune Response in the SAPHO Syndrome
An observational study of SAPHO Syndrome, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The aetiology of SAPHO syndrome seems to involve genetic, infectious and immunological components. The investigators examined innate and adaptative immune responses in SAPHO syndrome as compared with psoriatic arthritis and rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 1 year to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- SAPHO Syndrome
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to May 2008
- 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 1 year to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: SAPHO syndrome patients
Who may be able to join
- Clinical diagnosis of SAPHO syndrome
- Must have bone lesions
Who cannot join
- Infliximab treatment
About this study
Official title: Immune Mechanisms During SAPHO Syndrome and Treatment by Etarnecept
The aetiology of SAPHO syndrome seems to involve genetic, infectious and immunological components. The investigators examined innate and adaptative immune responses in SAPHO syndrome as compared with psoriatic arthritis and rheumatoid arthritis.
- Conditions
- SAPHO Syndrome
- Keywords
- SAPHO syndrome, Innate immunity, TNF alpha, Polymorphonuclear neutrophils, Propionibacterium acnes, Interleukin-8
- Medical subject headings
- Acquired Hyperostosis Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-8 production by PMN
Measured: 24 h
Secondary outcomes (1)
TNFalpha production by PMN
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startNov 2005
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SAPHO SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Hayem, PhD, Study director, Assitance Publique-Hopitaux Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688219
- Sponsor's protocol ID
- 45896566645469
- Status last verified
- Oct 2007
- First submitted
- 14 Sep 2012
- Last updated
- 19 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Mechanisms During SAPHO Syndrome and Treatment by Etarnecept
- ClinicalTrials.gov ID
- NCT01688219
- Acronym / sponsor ID
- 45896566645469
- Conditions
- SAPHO Syndrome
- Keywords
- SAPHO syndrome, Innate immunity, TNF alpha, Polymorphonuclear neutrophils, Propionibacterium acnes, Interleukin-8
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- May 2008 (actual)
- First posted
- 19 Sep 2012 (estimated)
- 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.
The aetiology of SAPHO syndrome seems to involve genetic, infectious and immunological components. The investigators examined innate and adaptative immune responses in SAPHO syndrome as compared with psoriatic arthritis and rheumatoid arthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- SAPHO syndrome patients
Key inclusion criteria (2 listed)
- Clinical diagnosis of SAPHO syndrome
- Must have bone lesions
Key exclusion criteria (1 listed)
- Infliximab treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IL-8 production by PMN
Time frame: 24 h
1 secondary outcome
TNFalpha production by PMN
Time frame: 24 h
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 19 Sep 2012.
Related trials for SAPHO Syndrome
RecruitingPhase 2/3
Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome
SAPHO Syndrome
RecruitingObservational study
Study of the Pathophysiological Mechanisms Involved in the SAPHO Syndrome: Genetic Component and Immune Response
SAPHO Syndrome
RecruitingObservational study
Typological Study of Sleep Pathologies During Psoriatic Rheumatism and SAPHO Syndrome: Prospective Study Within the Paris Saint-Joseph Hospital Group"
Psoriasis Arthritis, SAPHO Syndrome
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.
Gilles Hayem, PhD study director
Assitance Publique-Hopitaux Paris
Questions about this trial
What is this clinical trial studying?
An observational study of SAPHO Syndrome, run by Assistance Publique - Hôpitaux de Paris.
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 1 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 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
IL-8 production by PMN (time frame: 24 h). 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 19 Sep 2012.