Assessment of SpondyloArthritis Society (ASAS) Classification and Diagnostic Criteria for Early Axial Spondyloarthritis (SpA)
Status unconfirmed
Conditions studied: Spondyloarthritis, Spondylarthropathy, Spondylitis, Ankylosing
In brief
Background: Existing criteria for AS/SpA such as mod. New York, ESSG, or Amor criteria for classification and/or diagnosis of spondyloarthritis have limitations when applied to early disease. Moreover, MRI is not part of any of the established criteria and the precise role of MRI in early axial disease has not been fully defined yet. Even less is known about sacroiliac (SI) changes in SpA patients with peripheral symptoms. A pilot study using data from 'paper patients' led to new candidate criteria for early spondyloarthritis. Subsequently, the members of the ASAS International Working Group decided to conduct a prospective multi-centre study to evaluate (validate) the new candidate criteria, and to assess their performance as diagnostic criteria. Aims of the study: 1. To evaluate the new candidate criteria for axial SpA in a multi-centre setting. 2. To assess the potential role of the new candidate criteria to be used as diagnostic criteria. To accomplish this, inclusion of consecutive and undiagnosed patients is mandatory as are longer periods of follow-up . 3. To compare criteria encompassing the whole group of SpA such as ESSG and Amor criteria against criteria which are tailored to either predominant axial disease or predominant peripheral disease. To accomplish this, both patients with predominant axial disease (back pain) but also patient with predominant peripheral disease (arthritis/enthesitis) will be included.
Key facts
- Study ID
- NCT00328068
- Run by
- Charite University, Berlin, Germany
- People needed
- 992
- Starts
- 2006-07-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2013-02-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Include newly referred patients if:
- Onset of symptoms (back pain/arthritis/enthesitis) < 45 years
- Undiagnosed disease with the following symptoms:
- chronic back pain (duration of back pain more than 3 months)
- and/or peripheral arthritis (asymmetric arthritis/predominantly of the lower limbs)
- and/or enthesitis
- and/or dactylitis
You may not qualify if…
- No symptoms such as specified in inclusion criteria: back pain, arthritis, enthesitis
- Definite diagnosis
Where it is running
- ChapelChapel Allerton Hospital — Leeds, United Kingdom (enrolling)
- University Hospital Gent — Ghent, Belgium (enrolling)
- University Hospital Maastricht — Maastricht, Netherlands (enrolling)
- Hospital Universitario "Reina Sofia" — Córdoba, Spain (enrolling)
- Balgrist University Hospital — Zurich, Switzerland (enrolling)
- Veterans General Hospital Taipei — Beitou Dist. Taipei, Taiwan (enrolling)
- Wei — Taichung, Taiwan (enrolling)
- Duruöz — Bornova, Turkey (Türkiye) (enrolling)
- Division of Rheumatology — Elâzığ, Turkey (Türkiye) (enrolling)
- Izmir University Hospital — Izmir, Turkey (Türkiye) (enrolling)
- King George Hospital — Goodmayes, United Kingdom (enrolling)
- University of Alberta — Edmonton, Alberta, Canada (enrolling)
- Chinese PLA General Hospital — Beijing, China (enrolling)
- Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, China (enrolling)
- Division of Rheumatology — Bogotá, Colombia (enrolling)
- Hvidovre Hospital, University of Copenhagen — Hvidovre, Denmark (enrolling)
- Rheumatology B Department — Paris, France (enrolling)
- Brandt — Berlin, Germany (enrolling)
- Universitaetsmedizin Berlin, Charité Campus Benjamin-Franklin, Med. Clinic I, Rheumatology, Hindenburgdamm 30 — Berlin, Germany (enrolling)
- Rheumazentrum Ruhrgebiet — Herne, Germany (enrolling)
- St. Vincent's Hospital — Dublin, Ireland (enrolling)
- University of Florence — Florence, Italy (enrolling)
- Arcispedale S. Maria Nouva — Reggio Emilia, Italy (enrolling)
- Caterina Naclerio — Scafati (SA), Italy (enrolling)
- VU University Medical Center — Amsterdam, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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