Unmet Needs of Axial Spondyloarthrits in Egyptian Patients

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Axial Spondyloarthritis
• Intervention / Treatment: Other: ASDAS score , VAS score, BASFI score , Katz ADL index

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Toqa M Mohamed, resident; Phone Number: 01282998008; Email: toka011070@med.sohag.edu.eg
• Study Contact Backup: Name: Essam M Abolfadl, Professor

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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 .

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(ASDAS score ) The Ankylosing Spondylitis Disease Activity score	an index to assess disease activity in Ankylosing Spondylitis (AS).	3 months
(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
(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
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

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis
• Other Study ID Numbers: Soh-Med-22-08-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No