Unmet Needs of Axial Spondyloarthrits in Egyptian Patients

NCT ID: NCT05517031

Last Updated: 2022-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-03-31

Brief Summary

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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 .

Detailed Description

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Conditions

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Axial Spondyloarthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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 .
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Toqa Mahfouz Mohamed Ahmed

Resident doctor at rheumatology and rehabilitation department faculty of medicine Sohag university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Toqa M Mohamed, resident

Role: CONTACT

01282998008

Essam M Abolfadl, Professor

Role: CONTACT

Facility Contacts

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Osama R Elsherief, Professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 24013647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22450391 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27558584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19297344 (View on PubMed)

Other Identifiers

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Soh-Med-22-08-04

Identifier Type: -

Identifier Source: org_study_id

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