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Assessment of SpondyloArthritis Society (ASAS) Classification and Diagnostic Criteria for Early Axial Spondyloarthritis (SpA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00328068
Recruitment Status : Unknown
Verified February 2013 by J. Sieper, Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : May 19, 2006
Last Update Posted : February 13, 2013
Information provided by (Responsible Party):
J. Sieper, Charite University, Berlin, Germany

Brief Summary:


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.

Condition or disease
Spondyloarthritis Spondylarthropathy Spondylitis, Ankylosing

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Study Type : Observational
Estimated Enrollment : 992 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, International, Multi-centre Study on ASAS Classification Criteria for SpA
Study Start Date : July 2006
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Diagnosis of Spondyloarthritis [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Patients with a retained diagnosis of spondyloarthritis after follow-up [ Time Frame: 2-5 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic back pain of unknown origin or peripheral arthritis / enthesitis / dactylitis of unknown origin who are referred to a rheumatologist for diagnostic work-up

Inclusion Criteria:

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

Exclusion Criteria:

  • No symptoms such as specified in inclusion criteria: back pain, arthritis, enthesitis
  • Definite diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00328068

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Contact: Martin Rudwaleit, MD +49(0)30-8445 ext 4535
Contact: In-Ho Song, MD +49(0)30-8445 ext 4795

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Sponsors and Collaborators
Charite University, Berlin, Germany
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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
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: J. Sieper, Prof., Charite University, Berlin, Germany Identifier: NCT00328068    
Other Study ID Numbers: ASAS-class-crit-1
First Posted: May 19, 2006    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013
Keywords provided by J. Sieper, Charite University, Berlin, Germany:
ASAS classification
ASAS diagnostic criteria
spondylitis, ankylosing
modified New York criteria for AS
ESSG criteria for SpA
Amor criteria for SpA
magnetic resonance imaging
Additional relevant MeSH terms:
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Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases