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

NCT00328068 | Unknown DMC

• 1 other identifier: ASAS-class-crit-1
• Study Type: observational
• Target: 992
• Locations: 20 countries
• Sites: 35

Brief Summary

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. 1.To evaluate the new candidate criteria for axial SpA in a multi-centre setting.
2. 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. 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.

Conditions

Spondyloarthritis; Spondylarthropathy; Spondylitis, Ankylosing

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Diagnosis of Spondyloarthritis

  2 years

Secondary Outcomes (1)

• Patients with a retained diagnosis of spondyloarthritis after follow-up

  2-5 years

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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:

• Definite diagnosis

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (35)

Case Western Reserve University at MetroHealth Medical Centre

Cleveland, Ohio, 44109, United States

NOT YET RECRUITING

University Hospital Gent

Ghent, B-9000, Belgium

RECRUITING

Rheumatology Division

São Paulo, Brazil

NOT YET RECRUITING

University of Alberta

Edmonton, Alberta, T6G 252, Canada

RECRUITING

The Toronto Hospital

Toronto, Ontario, ON M5T 2S8, Canada

NOT YET RECRUITING

Chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, 510630, China

RECRUITING

Division of Rheumatology

Bogotá, Colombia

RECRUITING

Hvidovre Hospital, University of Copenhagen

Hvidovre, 2650, Denmark

RECRUITING

Service de Rheumatologie

Marseille, France

NOT YET RECRUITING

Rheumatology B Department

Paris, 75014, France

RECRUITING

Brandt

Berlin, 12163, Germany

RECRUITING

Universitaetsmedizin Berlin, Charité Campus Benjamin-Franklin, Med. Clinic I, Rheumatology, Hindenburgdamm 30

Berlin, 12200, Germany

RECRUITING

Rheumazentrum Ruhrgebiet

Herne, 44625, Germany

RECRUITING

Géher

Budapest, H-1027, Hungary

NOT YET RECRUITING

Seroja Rheumatic Centre

Semarang, 50241, Indonesia

NOT YET RECRUITING

St. Vincent's Hospital

Dublin, 4, Ireland

RECRUITING

University of Florence

Florence, 50122, Italy

RECRUITING

Arcispedale S. Maria Nouva

Reggio Emilia, 422100, Italy

RECRUITING

Caterina Naclerio

Scafati (SA), Italy

RECRUITING

Hospital General de México

Mexico City, DF 06726, Mexico

NOT YET RECRUITING

VU University Medical Center

Amsterdam, 1081 HV, Netherlands

RECRUITING

Kennemer Gasthuis, Locatie Deo

HG IJmuiden, 1971, Netherlands

RECRUITING

University Hospital Maastricht

Maastricht, 6229 HX, Netherlands

RECRUITING

Hospital Universitario "Reina Sofia"

Córdoba, 14004, Spain

RECRUITING

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

NOT YET RECRUITING

Balgrist University Hospital

Zurich, 8008, Switzerland

RECRUITING

Veterans General Hospital Taipei

Beitou Dist. Taipei, 112, Taiwan

RECRUITING

Wei

Taichung, 40201, Taiwan

RECRUITING

Duruöz

Bornova, 35050, Turkey (Türkiye)

RECRUITING

Division of Rheumatology

Elâzığ, Turkey (Türkiye)

RECRUITING

Izmir University Hospital

Izmir, Turkey (Türkiye)

RECRUITING

Glasgow Royal Infirmary, Queen Elizabeth Building

Glasgow, G31 2 ER, United Kingdom

NOT YET RECRUITING

King George Hospital

Goodmayes, IG3 8YB, United Kingdom

RECRUITING

ChapelChapel Allerton Hospital

Leeds, LS7 4SA, United Kingdom

RECRUITING

Related Publications (3)

• Rudwaleit M, Metter A, Listing J, Sieper J, Braun J. Inflammatory back pain in ankylosing spondylitis: a reassessment of the clinical history for application as classification and diagnostic criteria. Arthritis Rheum. 2006 Feb;54(2):569-78. doi: 10.1002/art.21619.

  PMID: 16447233 BACKGROUND

• Rudwaleit M, Sieper J. Positive and negative predictive values from published studies can be misleading for decision-making in clinical practice. Rheumatology (Oxford). 2006 Jun;45(6):779-80; author reply 780-1. doi: 10.1093/rheumatology/kel083. Epub 2006 Apr 4. No abstract available.

  PMID: 16595519 BACKGROUND

• Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17.

  PMID: 19297344 DERIVED

Related Links

• ASAS is an international society of experts in the field of spondyloarthritis.

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

MeSH Terms

Conditions

Spondylarthritis; Spondylarthropathies; Spondylitis, Ankylosing; Arthritis

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Axial Spondyloarthritis; Ankylosis

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Rudwaleit, MD

CONTACT

+49(0)30-8445; martin.rudwaleit@charite.de

In-Ho Song, MD

CONTACT

+49(0)30-8445; in-ho.song@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 18, 2006
• First Posted: May 19, 2006
• Study Start: July 1, 2006
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

DK (1); HU (1); ME (1); ES (2); GB (3); IE (1); US (1); BE (1); CN (2); CH (1); ID (1); BR (1); NL (3); IT (3); CA (2); CO (1); TU (3); FR (2); DE (3); TW (2)