Immune Response in the SAPHO Syndrome | NCT01688219

Studies
Immune Response in the SAPHO Syndrome

NCT01688219

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Sep 19, 2012Estimated

Enrollment

39Actual

Phase

Not provided

Conditions

SAPHO Syndrome

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

May 2008Actual

First Submitted Date

Sep 14, 2012

First Submission Date that Met QC Criteria

Sep 18, 2012

First Posted Date

Sep 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2012

Last Update Posted Date

Sep 19, 2012Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Measure	Description	Time Frame
IL-8 production by PMN		24 h

Measure	Description	Time Frame
TNFalpha production by PMN		24 h

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of SAPHO syndrome
Must have bone lesions

Exclusion Criteria:

Infliximab treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

SAPHO syndrome patients

Sampling Method

Probability Sample

Name	Affiliation	Role
Gilles Hayem, PhD	Assitance Publique-Hopitaux Paris	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D020083	Acquired Hyperostosis Syndrome

Ancestor Terms

ID	Term
D010009	Osteochondrodysplasias
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided