Assessment of SpondyloArthritis Society (ASAS) Classification and Diagnostic Criteria for Early Axial Spondyloarthritis (SpA)
Recruitment status was Recruiting
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:
- To evaluate the new candidate criteria for axial SpA in a multi-centre setting.
- 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 .
- 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective, International, Multi-centre Study on ASAS Classification Criteria for SpA|
- Diagnosis of Spondyloarthritis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Patients with a retained diagnosis of spondyloarthritis after follow-up [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
DNA and RNA will be collected in selected centres for analysis of candidate gene variants in ankylosing spondylitis/ spondyloarthritis. Serum and plasma sample will be collected for biomarker analysis with special focus on markers of bone metabolism
|Study Start Date:||July 2006|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Back pain / peripheral arthritis
Patients with chronic back pain of unknown origin and onset of back pain <45 years of age or patients with peripheral arthritis / enthesitis / dactylitis of unknown origin and onset <45 years of age
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00328068
|Contact: Martin Rudwaleit, MD||+49(0)30-8445 ext email@example.com|
|Contact: In-Ho Song, MD||+49(0)30-8445 ext firstname.lastname@example.org|
Show 35 Study Locations
|Principal Investigator:||Martin Rudwaleit, MD||Universitatsmedizin Berlin, Charité Campus Benjamin-Franklin, Med. Clinic I, Rheumatology, Hindenburgdamm 30, 12200 Berlin, Germany|
|Principal Investigator:||Joachim Sieper, MD||Charité Universtaetsmedizin Berlin|