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Trial registered on ANZCTR

Registration number

ACTRN12617001299392

Ethics application status

Not required

Date submitted

11/08/2017

Date registered

11/09/2017

Date last updated

24/08/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

An audit of clinical service delivery and outcomes using Tumour Necrosis Factor Inhibition therapy (- a Biological agent that targets inflammation) for the treatment of Diffuse Idiopathic Skeletal Hyperostosis (a condition where calcification of ligaments, tendons and joint capsule insertions in the spine causes pain, stiffness and restricted movements).

Scientific title

An Audit Of Clinical Service Delivery And Outcomes In Diffuse Idiopathic Skeletal Hyperostosis – Preliminary Evidence For The Efficacy Of Tumour Necrosis Factor Inhibition Therapy.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Nil known

Trial acronym

Linked study record

Nil

Health condition

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

Diffuse idiopathic skeletal hyperostosis

Hyperostosis

Condition category

Condition code

Inflammatory and Immune System

Autoimmune diseases

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

To investigate outcomes of treatment over an 11-year period (2006 to 2017 inclusive), in patients with diffuse idiopathic skeletal hyperostosis (DISH) the medical records of 10 patients with DISH treated with tumour necrosis factor inhibitors (TNFi), will be retrospectively audited and will be compared with 13 DISH patients that are not treated with TNFi, and also compared with patients with 42 ankylosing spondylitis (AS) who will be identified from a national rheumatology database (Australian Rheumatology Association Database - ARAD)

Intervention code [1]

Not applicable

Comparator / control treatment

13 DISH patients that were not treated with TNFi will be compared as controls. They also met radiologic criteria for diagnosis and were identified using the same method as the treated DISH patients- that is physician recall and a word search of hospital clinic letters. The TNFi and control patients will also be compared with 42 AS patients identified from Australian Rheumatology Association Database (ARAD).

Control group

Active

Outcomes

Primary outcome [1]

Bath Ankylosing Spondylitis Disease Activity Index scores will be used to assess response.

Timepoint [1]

5 years after diagnosis

Secondary outcome [1]

BASDAI score

Timepoint [1]

9 years after diagnosis

Eligibility

Key inclusion criteria

Radiological criteria for DISH were applied. Patients were classified on the basis described by Fornasier, Littlejohn and Urowitz (Fornasier V, Littlejohn G, Urowitz M, Keystone E, Smythe H. Spinal entheseal new bone formation: the early changes of spinal diffuse idiopathic skeletal hyperostosis. J Rheum 1983;10:939-47). They were also evaluated for characteristic changes of an inflammatory sacro-iliitis.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Those people without DISH.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Both

Statistical methods / analysis

Analysis of variance (ANOVA).

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

Actual

8/05/2007

Date of last participant enrolment

Anticipated

Actual

14/12/2015

Date of last data collection

Anticipated

1/12/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Fremantle Hospital and Health Service - Fremantle

Recruitment hospital [2]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

6160 - Fremantle

Recruitment postcode(s) [2]

6150 - Murdoch

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr Graeme Carroll

Address [1]

ArthroCare, 19A Guildford Rd, Mount Lawley, Western Australia, 6050

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Graeme Carroll

Address

ArthroCare, 19A Guildford Rd, Mount Lawley, Western Australia, 6050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

Australian Rheumatology Association

Address [1]

145 Macquarie Street
SYDNEY NSW 2000
Tel: (+61 2) 9252 2356
Fax: (+61 2) 9252 2328
email: [email protected]

Country [1]

Australia

Ethics approval

Ethics application status

Not required

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Diffuse idiopathic skeletal hyperostosis (DISH),  is a skeletal disorder for which, apart from non-steroidal anti-inflammatory drugs and analgesics, there is no effective pharmacological treatment. The aim of this retrospective/prospective data audit is to determine the effect of tumour necrosis factor inhibitors in clinically active  DISH patients. This will be achieved by the comparison of changes in pain and function in people with DISH that are treated with tumour necrosis factor inhibitor (TNFi) to similar people with DISH that are not treated with TNFi, with people with ankylosing spondylitis, over time.

Trial website

Trial related presentations / publications

Public notes

This retrospective audit has identified people with DISH and will examine their results from 8/05/2007 until present day with the anticipation that these people will be followed until 1/12/2026.

Ethics approval was not required according to the WA Health Research Governance Policy and Procedures: 
3.2.3 Exemption from Ethical and Scientific Review In accordance with the National Statement (Chapter 5.1), WA Health provides the discretion to exempt from ethical review research that:  is negligible risk research; and  involves the use of existing collections of data or records that contain only nonidentifiable data about human beings. 

In our case:
•	The manuscript does not report on primary research. Participants were not recruited for study, but rather were evaluated and in some cases treated empirically in the context of clinical service provision. All data analysed were collected as part of routine diagnosis and patient care.
•	Patients were diagnosed and treated in accordance with national guidelines. The tests and procedures performed (as well as recording all other variables included in our analysis) were routine and essential for confirming diagnosis and classifying patients. The imaging and other investigations had been performed as part of routine care. They were not done as an add-on for purposes of research.
•	The paper does not report on the use of experimental or new protocols. The outcomes of observation and in some cases empirical “off label” therapies was a variation of an accepted treatment protocol.
•	The audit was not set up as a study or research project, but as a review of treatment practices and outcomes. Hence we did not seek/obtain ethical approval for a study. 
•	Our analysis looked retrospectively at outcomes for a cohort of patients treated or observed over an extensive period of time. This was done internally as part of an audit/evaluation, with a view to improving quality of care. 


Ref: Department of Health. (2012). WA Health Research Governance Policy and Procedures, Research Development Unit, Department of Health, Perth.

Contacts

Principal investigator

Name

Prof Graeme Carroll

Address

ArthroCare
19A Guildford Rd, Mount Lawley, Western Australia, 6050

Country

Australia

Phone

+61892716306

Fax

+61893703957

[email protected]

Contact person for public queries

Name

Graeme Carroll

Address

ArthroCare
19A Guildford Rd, Mount Lawley, Western Australia, 6050

Country

Australia

Phone

+61892716306

Fax

+61893703957

[email protected]

Contact person for scientific queries

Name

Graeme Carroll

Address

ArthroCare
19A Guildford Rd, Mount Lawley, Western Australia, 6050

Country

Australia

Phone

+61892716306

Fax

+61893703957

[email protected]

No information has been provided regarding IPD availability

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

No additional documents have been identified.

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