ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000445178

Ethics application status

Not required

Date submitted

8/03/2019

Date registered

18/03/2019

Date last updated

18/03/2019

Date data sharing statement initially provided

18/03/2019

Date results provided

18/03/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Clinical outcomes of an inflammatory bone disorder that may be associated with skin disorders.

Scientific title

Long-term clinical outcomes in Synovitis Acne Pustulosis Hyperostosis and Osteitis syndrome

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1228-8056

Trial acronym

SAPHO

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Synovitis Acne Pustulosis Hyperostosis and Osteitis syndrome

Condition category

Condition code

Inflammatory and Immune System

Autoimmune diseases

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

The clinical features and treatment outcomes in a cohort of 21 patients diagnosed with Synovitis, Acne, Pustulosis, Hyperostosis and Osteitis or SAPHO syndrome, in Western Australia were reviewed retrospectively over a 32-year period by chart review and electronic medical record interrogation.
No involvement or consent was required. This was a retrospective data audit .

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Primary outcome 1 (composite outcome): describe the clinical and treatment outcomes as well as the natural history of SAPHO in a cohort of patients as assessed by data linkage to medical records

Timepoint [1]

Retrospectively followed for up to 32 years

Secondary outcome [1]

The clinical effect of tumour necrosis factor inhibitor (TNFi) on SAPHO as assessed by exposure to TNFi using data linkage to medical records.

Timepoint [1]

Retrospectively followed for up to 32 years

Eligibility

Key inclusion criteria

Diagnosis of SAPHO as defined as multifocal osteitis with/without skin symptoms, sterile acute or chronic joint inflammation with either palmoplantar pustulosis or psoriasis, or acne or hidradenitis, with sterile osteitis with any one of these sets of criteria deemed sufficient for diagnosis.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Those people that did not meet the criteria required to be diagnosed with SAPHO (multifocal osteitis with/without skin symptoms, sterile acute or chronic joint inflammation with either palmoplantar pustulosis or psoriasis, or acne or hidradenitis, with sterile osteitis with any one of these sets of criteria).

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Defined population

Timing

Retrospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/01/1986

Date of last participant enrolment

Anticipated

Actual

2/12/2018

Date of last data collection

Anticipated

Actual

2/12/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [2]

Fremantle Hospital and Health Service - Fremantle

Recruitment hospital [3]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [4]

Royal Perth Hospital - Perth

Recruitment postcode(s) [1]

6150 - Murdoch

Recruitment postcode(s) [2]

6160 - Fremantle

Recruitment postcode(s) [3]

6009 - Nedlands

Recruitment postcode(s) [4]

6000 - Perth

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Graeme Carroll

Address

ArthroCare
19A Guildford Road,
Mt Lawley
WA 6050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not required

Summary

Brief summary

Synovitis, Acne, Pustulosis, Hyperostosis and Osteitis or SAPHO syndrome, is a rare immuno-inflammatory bone disease that may be associated with skin changes. There are no clear guidelines for treatment. To assess the outcome of previously observed therapeutic treatments in SAPHO, we examined outcomes in 21 patients collected over more than 30 years of clinical experience. Mostly good or very good long-term treatment outcomes were observed in older bisphosphonate medications and newer biologic treatment called tumour necrosis factor inhibitor (TNFi) treatment.

Trial website

Trial related presentations / publications

Public notes

This project was registered and approved as a quality assurance project (QA26150) by Fiona Stanley Hospital Human Research Ethics Committee on 19 of March 2018 and, as such, did not require formal Human Research Ethics Committee Review.

Contacts

Principal investigator

Name

A/Prof Graeme Carroll

Address

ArthroCare
19A Guildford Rd
Mount Lawley
WA 6050

Country

Australia

Phone

+61 08 92716306

Fax

+61 08 9370 3957

[email protected]

Contact person for public queries

Name

Graeme Carroll

Address

ArthroCare
19A Guildford Rd
Mount Lawley
WA 6050

Country

Australia

Phone

+61 08 92716306

Fax

+61 08 9370 3957

[email protected]

Contact person for scientific queries

Name

Graeme Carroll

Address

ArthroCare
19A Guildford Rd
Mount Lawley
WA 6050

Country

Australia

Phone

+61 08 92716306

Fax

+61 08 9370 3957

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All of the individual participant data collected during the trial, after de-identification; individual participant data underlying published results only.

When will data be available (start and end dates)?

Immediately following publication, no end date.

Available to whom?

Researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor

Available for what types of analyses?

For further research into SAPHO; only to achieve the aims in the approved proposal; for IPD meta-analyses.

How or where can data be obtained?

Access subject to approvals by Principal Investigator, requirement to sign data access agreement

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Long-term Clinical Outcomes in Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis Syndrome.	2021	https://dx.doi.org/10.1016/j.mayocpiqo.2021.02.009

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically