Unmet Needs of Axial Spondyloarthrits in Egyptian Patients

NCT05517031 | Unknown

• 1 other identifier: Soh-Med-22-08-04
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 .

Conditions

Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (4)

• (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

Interventions

ASDAS score , VAS score, BASFI score , Katz ADL index OTHER

Scores that done on patient to fullfill criteria of diagnosis , and measure affection of disease on patients and their daily living activity

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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 .

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university hospital

Sohag, Egypt

Location

Related Publications (4)

• 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.

  PMID: 24013647 BACKGROUND

• 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.

  PMID: 22450391 BACKGROUND

• 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.

  PMID: 27558584 BACKGROUND

• 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.

  PMID: 19297344 BACKGROUND

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Central Study Contacts

Toqa M Mohamed, resident

CONTACT

01282998008; toka011070@med.sohag.edu.eg

Essam M Abolfadl, Professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at rheumatology and rehabilitation department faculty of medicine Sohag university

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: January 1, 2023
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)