Unmet Needs of Axial Spondyloarthrits in Egyptian Patients

Axial Spondyloarthritis Clinical Trial

Official title:

Unmet Needs of Axial Spondyloarthrits in Egyptian Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05517031
• Other study ID #: Soh-Med-22-08-04
• Status: Not yet recruiting
• Start date: January 1, 2023
• Est. completion date: March 2023

Study information

• Verified date: December 2022
• Source: Sohag University
• Contact: Toqa M Mohamed, resident
• Phone: 01282998008
• Email: toka011070[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

Other:
• ASDAS score , VAS score, BASFI score , Katz ADL index
Scores that done on patient to fullfill criteria of diagnosis , and measure affection of disease on patients and their daily living activity

Locations

Country	Name	City	State
Egypt	Sohag university hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Erratum In: Ann Rheum Dis. 2019 Jun;78(6):e59. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(ASDAS score ) The Ankylosing Spondylitis Disease Activity score	an index to assess disease activity in Ankylosing Spondylitis (AS).	3 months
Primary	(VAS score ) Visual Analogue Score	A psychometric response scale for parameters that range across a continuum of values, such as pain. The VAS pain scale ranges from "no pain" to "worst pain," and patients mark a line to indicate how they are feeling.	3 months
Primary	(BASFI score ) Bath Ankylosing Spondylitis Functional Index	The BASFI consists of 10 questions, answered on a VAS. The final score is the average of the questions, ranging from 0 (no limitation) to 10 (maximal limitation in function).	3 months
Primary	Katz Activity Daily Living	The Katz Activities of Daily Living (ADL) scale is a widely used graded instrument that assesses six primary and psychosocial functions: bathing, dressing, going to toilet, transferring, feeding, and continence.	3 months