Reliability of IBP Criteria & Activity Scores in Patients With AxSpA

NCT05327140 | Completed

• 1 other identifier: ZU-IRB #6983/13-6-2021
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

The current ASAS classification of AxSpA relies either on sacroiliitis on imaging plus one SpA feature (imaging arm) or HLA-B27 antigen plus two SpA features (clinical arm), in a patient with chronic back pain and age at onset of less than 45 years. IBP which is a major symptom of SpA depends more on patient's perception which is not usually accurate. As well, disease activity is measured by ASDAS, BASDAI, and BASFAI which depend more on subjective measures. Assessment of reliability of IBP criteria, ASDAS, BASDAI, and BASFAI in diagnosis and evaluation of activity of AxSpA is essential for better health care.

Conditions

Axial Spondyloarthritis; Inflammatory Back Pain

Outcome Measures

Primary Outcomes (2)

• assessment of reliability, sensitivity, and specificity of inflammatory back pain criteria (the Assessment of SpondyloArthritis international Society IBP experts criteria) depending on a gold standard which is the global evaluation of the rheumatologist.

  Assessment of reliability of each item and the whole set of inflammatory back pain criteria ( the Assessment of SpondyloArthritis international Society (ASAS) IBP experts criteria) depending on a gold standard which is the global evaluation of expert rheumatologist: is it inflammatory or mechanical back pain. The Assessment of SpondyloArthritis international Society (ASAS) IBP experts criteria includes 5 items: age at onset ≤ 40 years, insidious onset, improvement with exercise, no improvement with rest, pain at night. This set of criteria is achieved if at least four parameters are met.

  8/2021 to 5/2022

• assessment of reliability of Ankylosing Spondylitis Disease Activity Score in axial spondyloarthritis patients.

  Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) includes 4 questions about disease activity (Axial pain, Peripheral Pain/Swelling, Duration of Morning Stiffness, activity of the disease on average during the last week) and CRP. Each question has a score from 0 to 10. 0 means no, and 10 means sever. ASDAS\_CRP = 0.121 × total back pain + 0.110 × patient global + 0.073 × peripheral pain / swelling + 0.058 × duration of morning stiffness + 0.579 × Ln (CRP+1). ASDAS scores : \<1.3 "inactive disease" and \<2.1"low disease activity", ≤3.5 "high disease activity", and \>3.5 "very high disease activity". The score is applied to the same group of patients by 2 rheumatologists. The scores of each question and the total score that detected by the two rheumatologists are compared to detect agreement between the two rheumatologist and assess reliability of this score

  8/2021 to 5/2022

Study Arms (2)

patients with axial spondyloarthritis

ASAS classification criteria which relies either on sacroiliitis on imaging plus one SpA feature (imaging arm) or HLA-B27 antigen plus two SpA features (clinical arm), in a patient with chronic back pain and age at onset of less than 45 years

patients with mechanical back pain

Patients diagnosed as chronic (more than 3 months) mechanical back pain, the diagnosis has been made prior to the study by the treating specialist, these patients are herein as a control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group 1 Patients diagnosed as AxSpA according to the ASAS classification criteria for AxSpA. Group 2 Patients diagnosed as chronic (more than 3 months) mechanical back pain, the diagnosis has been made prior to the study by the treating specialist, these patients are herein as a control group.

You may qualify if:

• Group 1
• Patients diagnosed as AxSpA.
• Age \> 18 years and \< 45 years at onset of the disease. Group 2
• Patients diagnosed as chronic mechanical back pain.
• Age \> 18 years and \< 45 years at onset of the disease.

You may not qualify if:

• Patients having acute or subacute back pain.
• Patients having back pain referred from another site.
• Patients with any other autoimmune disease: rheumatoid arthritis, systemic lupus erythematosus, Behçet's disease… etc.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university

Zagazig, Sharqia Province, Egypt

Location

Related Publications (12)

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  PMID: 140252 BACKGROUND

• Calin A, Garrett S, Whitelock H, Kennedy LG, O'Hea J, Mallorie P, Jenkinson T. A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol. 1994 Dec;21(12):2281-5.

  PMID: 7699629 BACKGROUND

• Deodhar A, Blanco R, Dokoupilova E, Hall S, Kameda H, Kivitz AJ, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Richards HB, Haemmerle S, Braun J. Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo-Controlled Phase III Study. Arthritis Rheumatol. 2021 Jan;73(1):110-120. doi: 10.1002/art.41477. Epub 2020 Nov 24.

  PMID: 32770640 BACKGROUND

• Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol. 1994 Dec;21(12):2286-91.

  PMID: 7699630 BACKGROUND

• Machado P, van der Heijde D. How to measure disease activity in axial spondyloarthritis? Curr Opin Rheumatol. 2011 Jul;23(4):339-45. doi: 10.1097/BOR.0b013e3283470f23.

  PMID: 21519269 BACKGROUND

• Poddubnyy D, Callhoff J, Spiller I, Listing J, Braun J, Sieper J, Rudwaleit M. Diagnostic accuracy of inflammatory back pain for axial spondyloarthritis in rheumatological care. RMD Open. 2018 Dec 5;4(2):e000825. doi: 10.1136/rmdopen-2018-000825. eCollection 2018.

  PMID: 30713715 BACKGROUND

• Reveille JD. Biomarkers for diagnosis, monitoring of progression, and treatment responses in ankylosing spondylitis and axial spondyloarthritis. Clin Rheumatol. 2015 Jun;34(6):1009-18. doi: 10.1007/s10067-015-2949-3. Epub 2015 May 5.

  PMID: 25939520 BACKGROUND

• Ritchlin C, Adamopoulos IE. Axial spondyloarthritis: new advances in diagnosis and management. BMJ. 2021 Jan 4;372:m4447. doi: 10.1136/bmj.m4447.

  PMID: 33397652 BACKGROUND

• Rudwaleit M, Metter A, Listing J, Sieper J, Braun J. Inflammatory back pain in ankylosing spondylitis: a reassessment of the clinical history for application as classification and diagnostic criteria. Arthritis Rheum. 2006 Feb;54(2):569-78. doi: 10.1002/art.21619.

  PMID: 16447233 BACKGROUND

• Rudwaleit M, Landewe R, van der Heijde D, Listing J, Brandt J, Braun J, Burgos-Vargas R, Collantes-Estevez E, Davis J, Dijkmans B, Dougados M, Emery P, van der Horst-Bruinsma IE, Inman R, Khan MA, Leirisalo-Repo M, van der Linden S, Maksymowych WP, Mielants H, Olivieri I, Sturrock R, de Vlam K, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part I): classification of paper patients by expert opinion including uncertainty appraisal. Ann Rheum Dis. 2009 Jun;68(6):770-6. doi: 10.1136/ard.2009.108217. Epub 2009 Mar 17.

  PMID: 19297345 BACKGROUND

• Sieper J, van der Heijde D, Landewe R, Brandt J, Burgos-Vagas R, Collantes-Estevez E, Dijkmans B, Dougados M, Khan MA, Leirisalo-Repo M, van der Linden S, Maksymowych WP, Mielants H, Olivieri I, Rudwaleit M. New criteria for inflammatory back pain in patients with chronic back pain: a real patient exercise by experts from the Assessment of SpondyloArthritis international Society (ASAS). Ann Rheum Dis. 2009 Jun;68(6):784-8. doi: 10.1136/ard.2008.101501. Epub 2009 Jan 15.

  PMID: 19147614 BACKGROUND

• van der Heijde D, Lie E, Kvien TK, Sieper J, Van den Bosch F, Listing J, Braun J, Landewe R; Assessment of SpondyloArthritis international Society (ASAS). ASDAS, a highly discriminatory ASAS-endorsed disease activity score in patients with ankylosing spondylitis. Ann Rheum Dis. 2009 Dec;68(12):1811-8. doi: 10.1136/ard.2008.100826. Epub 2008 Dec 5.

  PMID: 19060001 BACKGROUND

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

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

Study Officials

• Eman El-shahawy

  Zagazig University

  STUDY DIRECTOR

• Mohamed Mortada

  Zagazig University

  STUDY DIRECTOR

• Safaa Elnaggar

  Zagazig University

  STUDY DIRECTOR

• Noha Hamed

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: April 14, 2022
• Study Start: August 20, 2021
• Primary Completion: February 22, 2022
• Study Completion: May 25, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Locations

EG (1)