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).

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12617001299392

Enrollment

Registered

2017-09-11

Start date

2007-05-08

Completion date

2015-12-14

Last updated

2018-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 (Austral

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Exclusion criteria

Those people without DISH.

Outcome results