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

This study is currently recruiting participants.
Verified February 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
J. Sieper, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00328068
First received: May 18, 2006
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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.

Condition
Spondyloarthritis
Spondylarthropathy
Spondylitis, Ankylosing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, International, Multi-centre Study on ASAS Classification Criteria for SpA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Diagnosis of Spondyloarthritis [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 992
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)
Groups/Cohorts
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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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328068

Contacts
Contact: Martin Rudwaleit, MD +49(0)30-8445 ext 4535 martin.rudwaleit@charite.de
Contact: In-Ho Song, MD +49(0)30-8445 ext 4795 in-ho.song@charite.de

  Show 35 Study Locations
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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
  More Information

Additional Information:
ASAS is an international society of experts in the field of spondyloarthritis.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: J. Sieper, Prof., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00328068     History of Changes
Other Study ID Numbers: ASAS-class-crit-1
Study First Received: May 18, 2006
Last Updated: February 12, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
ASAS classification
ASAS diagnostic criteria
spondyloarthritis
spondyloarthropathy
spondylitis, ankylosing
modified New York criteria for AS
 ESSG criteria for SpA
Amor criteria for SpA
arthritis
enthesitis
magnetic resonance imaging

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Spondylarthropathies
Bone Diseases, Infectious
Infection
 Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on May 19, 2013