Description of Spondylarthritis and Validation of ASAS Criteria in West Indian Patients Seen in Consultation of Rheumatology.

NCT03564743 | Completed

• 1 other identifier: 14/E/20
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

In 2004 an ASAS for the Assessment of SpondyloArthritis International Society decided to work to improve the criteria for classification of spondyloarthropathies to allow for early diagnosis, Nuclear magnetic resonance imaging (MRI). This approach led to the publication in 2009 of the classification criteria for spondylarthritis, in particular axial spondyloarthritis, as well as a proposal to modify the classification of criteria defined by Mr. Amor (AMOR) and European Spondylarthropathy Study Group (ESSG) criteria, taking into account the potential abnormalities visible in Magnetic Resonance Imaging Nuclear (MRI). The performance (specificity, sensitivity, positive and negative predictive values) of the ASAS criteria was then prospectively tested on a sample of the Metropolitan Caucasian population and this systematic study allowed to estimate the performance of the ASAS criteria in the usual framework Of the French Liberal Rheumatology Consultation. Note that this approach is exposed to a criticism of "circular" approach, indeed the expert who is the gold standard for the diagnosis, uses more or less consciously "criteria" based on the presence of such and such sign, then checks in this selected population the diagnostic validity of these signs. However, no data on the performance of ASAS criteria are available in populations of African descent.

Conditions

Spondyloarthritis

Keywords

Spondyloarthritis; ASAS criteria; Diagnosis criteria; Classification criteria

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks.

  September 2018

• ASAS criteria

  Assess the performance of ASAS criteria (sensitivity, specificity, positive predictive value, negative predictive value) at the time of physician's diagnosis of chronic low back pain in rheumatological practice (Evaluation of the concept of "diagnostic criteria" and Classification criteria).

  September 2018

Secondary Outcomes (1)

• Assessment and comparison of ASAS performance against other classifications

  September 2018

Interventions

Evaluation of ASAS criteria DIAGNOSTIC_TEST

Perform ASAS criteria at the time of physician diagnosis of chronic low back pain in rheumatological practice.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with presence or history of chronic low back pain (≥ 3 months) that started before the age of 45 with an onset of low back pain after 2005

You may qualify if:

• Patient over 18 years of age
• Patient seen in the usual framework of the consultation of rheumatology
• Patients consulting with:
• Presence or history of chronic low back pain (≥ 3 months) that started before the age of 45 with an onset of low back pain after 2005:
• Or with known sacroiliitis or asymmetric inflammatory rheumatism
• Or with chronic inflammatory bowel disease (Crohn, ulcerative colitis (RCH) ...) and associated inflammatory rheumatism
• Patients who received a lumbosacral MRI after 2005
• Patient not participating in a clinical trial

You may not qualify if:

• Patient under 18 years of age
• Patient participating in another clinical trial

Sponsors & Collaborators

• University Hospital Center of Martinique: lead

Study Sites (1)

CHU de Martinique

Fort-de-France, 97261, Martinique

Location

Related Publications (8)

• Gran JT. An epidemiological survey of the signs and symptoms of ankylosing spondylitis. Clin Rheumatol. 1985 Jun;4(2):161-9. doi: 10.1007/BF02032287.

  PMID: 3159533 BACKGROUND

• Dougados M, van der Linden S, Juhlin R, Huitfeldt B, Amor B, Calin A, Cats A, Dijkmans B, Olivieri I, Pasero G, et al. The European Spondylarthropathy Study Group preliminary criteria for the classification of spondylarthropathy. Arthritis Rheum. 1991 Oct;34(10):1218-27. doi: 10.1002/art.1780341003.

  PMID: 1930310 BACKGROUND

• Amor B, Dougados M, Mijiyawa M. [Criteria of the classification of spondylarthropathies]. Rev Rhum Mal Osteoartic. 1990 Feb;57(2):85-9. French.

  PMID: 2181618 BACKGROUND

• van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum. 1984 Apr;27(4):361-8. doi: 10.1002/art.1780270401.

  PMID: 6231933 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

• Boy FN, Kayhan A, Karakas HM, Unlu-Ozkan F, Silte D, Aktas I. The role of multi-parametric MR imaging in the detection of early inflammatory sacroiliitis according to ASAS criteria. Eur J Radiol. 2014 Jun;83(6):989-996. doi: 10.1016/j.ejrad.2014.03.002. Epub 2014 Mar 22.

  PMID: 24703519 BACKGROUND

• Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988 Mar;31(3):315-24. doi: 10.1002/art.1780310302.

  PMID: 3358796 BACKGROUND

• Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.

  PMID: 20872595 BACKGROUND

MeSH Terms

Conditions

Spondylarthritis

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Officials

• Michel MD De Bandt

  CHU de Martinique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: June 21, 2018
• Study Start: September 1, 2015
• Primary Completion: November 1, 2020
• Study Completion: September 1, 2022
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)