Trial Review

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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] 292451 0
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 304061 0
Hyperostosis 304062 0
Condition category
Condition code
Inflammatory and Immune System 303387 303387 0 0
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] 298629 0
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] 302774 0
Bath Ankylosing Spondylitis Disease Activity Index scores will be used to assess response.
Timepoint [1] 302774 0
5 years after diagnosis
Secondary outcome [1] 337502 0
BASDAI score
Timepoint [1] 337502 0
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?
No
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
65
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 8791 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [2] 8792 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 16915 0
6150 - Murdoch
Recruitment postcode(s) [2] 16914 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 297019 0
Self funded/Unfunded
Name [1] 297019 0
Dr Graeme Carroll
Country [1] 297019 0
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] 296316 0
None
Name [1] 296316 0
Address [1] 296316 0
Country [1] 296316 0
Other collaborator category [1] 279678 0
Other Collaborative groups
Name [1] 279678 0
Australian Rheumatology Association
Address [1] 279678 0
145 Macquarie Street
SYDNEY NSW 2000
Tel: (+61 2) 9252 2356
Fax: (+61 2) 9252 2328
email: admin@rheumatology.org.au
Country [1] 279678 0
Australia

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 298204 0
Ethics committee address [1] 298204 0
Ethics committee country [1] 298204 0
Date submitted for ethics approval [1] 298204 0
Approval date [1] 298204 0
Ethics approval number [1] 298204 0

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 76326 0
Prof Graeme Carroll
Address 76326 0
ArthroCare
19A Guildford Rd, Mount Lawley, Western Australia, 6050
Country 76326 0
Australia
Phone 76326 0
+61892716306
Fax 76326 0
+61893703957
Email 76326 0
gjcarrollmd@gmail.com
Contact person for public queries
Name 76327 0
Graeme Carroll
Address 76327 0
ArthroCare
19A Guildford Rd, Mount Lawley, Western Australia, 6050
Country 76327 0
Australia
Phone 76327 0
+61892716306
Fax 76327 0
+61893703957
Email 76327 0
gjcarrollmd@gmail.com
Contact person for scientific queries
Name 76328 0
Graeme Carroll
Address 76328 0
ArthroCare
19A Guildford Rd, Mount Lawley, Western Australia, 6050
Country 76328 0
Australia
Phone 76328 0
+61892716306
Fax 76328 0
+61893703957
Email 76328 0
gjcarrollmd@gmail.com

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.