Clinical trial NCT05517031: Unmet Needs of Axial Spondyloarthrits in Egyptian Patients
Official title: Unmet Needs of Axial Spondyloarthrits in Egyptian Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Axial Spondyloarthritis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients fulfill the Assessment in Spondyloarthrits International Society (ASAS) classification criteria for Axial Spondyloarthritis With comorbidities as diabetes , hypertension , pregnancy , renal impairment or smoking

Brief summary: During the past decade, the well-known disease called Ankylosing Spondylitis has come to be considered as a subset of the broader entity referred as axial spondyloarthritis (axSpA), which also includes non-radiographic axSpA. The need of this new classification was aimed to improve the sensitivity for an early diagnosis, to reduce diagnostic delay, and to allow an early treatment. Although there is improvement in the recognition, the management of patients, and the treatment strategies of axSpA, unmet needs persist , there is still a substantial gap of 5-8 years between the onset of symptoms and the diagnosis of axSpA.

. This study is intended to enhance awareness and understanding of Axial Spondyloarthritis and to identify and discuss the current unmet needs in axSpA .

Multiple defects are still unfullfilled for axial SpA patients those defects include delayed diagnosis specially for female, failure to acheive treatment target, pain, impaired quality of life and associated comorbidities.

Up to the best of our knowledge this is the first study to highlight unmet needs for axial Spondyloarthritis patients in Egypt in general and in upper Egypt in particular .


Eligibility criteria: Inclusion Criteria

* Patients fulfill the Assessment in Spondyloarthrits International Society (ASAS) classification criteria for Axial Spondyloarthritis .
* Age above 16 years old.
* Patient cooperative and can answer questions .

Exclusion Criteria:

* Other rheumatologic or collagen diseases .
* Age below 16 years and above 60 years.
* Uncooperative patients .

Primary outcomes:
measure: (ASDAS score ) The Ankylosing Spondylitis Disease Activity score
timeFrame: 3 months
measure: (VAS score ) Visual Analogue Score
timeFrame: 3 months
measure: (BASFI score ) Bath Ankylosing Spondylitis Functional Index
timeFrame: 3 months
measure: Katz Activity Daily Living
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hospital
Study officials:
References:
citation: Landewe R, Braun J, Deodhar A, Dougados M, Maksymowych WP, Mease PJ, Reveille JD, Rudwaleit M, van der Heijde D, Stach C, Hoepken B, Fichtner A, Coteur G, de Longueville M, Sieper J. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study. Ann Rheum Dis. 2014 Jan;73(1):39-47. doi: 10.1136/annrheumdis-2013-204231. Epub 2013 Sep 6.
citation: Kiltz U, Heldmann F, Baraliakos X, Braun J. Treatment of ankylosing spondylitis in patients refractory to TNF-inhibition: are there alternatives? Curr Opin Rheumatol. 2012 May;24(3):252-60. doi: 10.1097/BOR.0b013e3283524b82.
citation: Hamilton L, Barkham N, Bhalla A, Brittain R, Cook D, Jones G, Mackay K, Marshall D, Marzo-Ortega H, Murphy D, Riddell C, Sengupta R, Siebert S, Van Rossen L, Gaffney K; BSR and BHPR Standards, Guidelines and Audit Working Group. BSR and BHPR guideline for the treatment of axial spondyloarthritis (including ankylosing spondylitis) with biologics. Rheumatology (Oxford). 2017 Feb;56(2):313-316. doi: 10.1093/rheumatology/kew223. Epub 2016 Aug 24. No abstract available.
citation: Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17.