Assessment of SpondyloArthritis Society (ASAS) Classification and Diagnostic Criteria for Early Axial Spondyloarthritis (SpA)
Sponsored by Charite University, Berlin, Germany
About this trial
Last updated 12 years ago
Study ID
ASAS-class-crit-1
Status
Unknown status
Type
Observational
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 12 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
- 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
Exclusion Criteria
- No symptoms such as specified in inclusion criteria: back pain, arthritis, enthesitis
- Definite diagnosis