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

Recruiting

• Source

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  Public Title	Assessment of SpondyloArthritis Society (ASAS) Classification and Diagnostic Criteria for Early Axial Spondyloarthritis (SpA)
  Acronym	Sorry, not currently available
  Source of Record URL	http://clinicaltrials.gov/show/NCT00328068

• Trial

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  Health Condition(s) or Problem	Spondyloarthritis; Spondylarthropathy; Spondylitis, Ankylosing
  Lay 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. 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. (from ClinicalTrials.gov)
  Who can enter the trial	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
  Who cannot enter the trial	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
  What will happen	Sorry, not currently available
  Primary aim	Diagnosis of Spondyloarthritis
  Secondary Aim	Patients with a retained diagnosis of spondyloarthritis after follow-up; 2-5 years; No
  Participant Information Sheet	Sorry, not currently available
  Website	http://www.asas-group.org/
  Recruitment Status	Recruiting
  Nation	Scotland, England
  Location	Glasgow, Ilford, Leeds

• Contact

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  Contact for Public Queries

  Martin Rudwaleit, MD +49(0)30-8445 martin.rudwaleit@charite.de Martin Rudwaleit, MD; Joachim Sieper, MD Principal Investigator; Principal Investigator Universitatsmedizin Berlin, Charité Campus Benjamin-Franklin, Med. Clinic I, Rheumatology, Hindenburgdamm 30, 12200 Berlin, Germany; Charité Universtaetsmedizin Berlin

  Contact for Scientific Queries

  Asim Muhammad Khan, Prof.; Principal Investigator; Filip van den Bosch; Principal Investigator; Rozana Ciconelli; Principal Investigator; Walter Maksymowych, MD; Principal Investigator; Robert Inman, MD; Principal Investigator; Feng Huang, Prof.; Principal Investigator; Jieruo Gu, MD; Principal Investigator; Rafael Valle-Oñate; Principal Investigator; Mikkel Ostergaard, Prof.; Principal Investigator; Thao Pham; Principal Investigator; Christophe Hudry, Dr.; Principal Investigator; Martin Rudwaleit, PD Dr.; Principal Investigator; Jan Brandt, PD Dr.; Principal Investigator; Heldmann, Dr.; Principal Investigator; Pál Géher, MD; Principal Investigator; John Darmawan, MD; Principal Investigator; Oliver Fitzgerald, Prof.; Principal Investigator; Marco Mattuci Cerinic, MD; Principal Investigator; Carlo Salvarani, MD; Principal Investigator; Caterina Naclerio, Dr.; Principal Investigator; Rubén Burgos Vargas, Prof.; Principal Investigator; I.E. van der Horst.-Bruinsma, MD; Principal Investigator; Annelies Linssen, MD; Principal Investigator; Désirée van der Heijde, Prof.; Principal Investigator; Eduardo Collantes-Estévez, MD; Principal Investigator; Carlos M Gonzáles Fernández, MD; Principal Investigator; Ulrich Weber, MD; Principal Investigator; Chung-Tei Chou, Dr.; Principal Investigator; James Wei, MD; Principal Investigator; Tuncay Duruöz, MD; Principal Investigator; Salih Ozgocmen, PhD; Principal Investigator; Roger Sturrock, Prof.; Principal Investigator; Euthalia Roussou, MD; Principal Investigator; Paul Emery, MD; Principal Investigator