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

February 12, 2013 updated by: J. Sieper, Charite University, Berlin, Germany

Prospective, International, Multi-centre Study on ASAS Classification Criteria for SpA

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Participating centres:

All ASAS members working in clinical practice are invited to participate in the study. More than one ASAS member/ rheumatologist per centre may participate.

Inclusion criteria:

Include newly referred patients if

  • onset of symptoms (back pain / arthritis / enthesitis) < 45 years and

  • undiagnosed* disease with the following symptoms:

    • chronic back pain (duration of back pain more than 3 months)
    • or / and peripheral arthritis (asymmetric arthritis / predominantly of the lower limbs)
    • or / and enthesitis

    • or / and dactylitis

      • Definition of 'undiagnosed':

The patient is being referred to your department because of chronic back pain, arthritis, enthesitis or dactylitis but has not been diagnosed confidently before by the referring physician/rheumatologist as having SpA or as definitely not having SpA. If the referring physician/GP/rheumatologist suspects SpA but is not certain about it, the patient is considered as undiagnosed.

Endpoints of the study:

  • Primary endpoint: the diagnosis made by the rheumatologist (ASAS member) after the diagnostic work-up. This expert diagnosis serves as preliminary gold standard against which the various criteria will be compared. Final gold standard will be the outcome (diagnosis) after long-term follow up.
  • Secondary endpoints: the diagnosis made by the rheumatologist at 2 and 5 years, respectively, after the first assessment. Thus, all patients should be invited to follow-up visits after 2 and 5 years, respectively.

Further study rules:

  • Include all newly referred patients strictly consecutively as long as they meet the inclusion criteria.
  • The decision to include a patient should be based solely on the fulfilment of the inclusion criteria, and should be made ideally before you make the final diagnosis (prospective study design).
  • Patients who have been diagnosed confidently and correctly by the referring physician prior to being referred to your department cannot be included in the study.
  • If you are unable to perform MRIs in your clinical setting you cannot include patients with undiagnosed chronic back pain.
  • If you want to include patients with undiagnosed chronic back pain, perform MRI of sacroiliac (SI) joints in the first 10 patients with axial SpA and in the first 10 patients with non-SpA related (mechanical) back pain. In subsequent patients you may perform MRIs as needed on clinical grounds. (Explanation: a minimum number of MRIs in both SpA and non-SpA patients from several centres is necessary to obtain reliable results on sensitivity and specificity of MRI in early axial SpA.)
  • MRI of SI joints in patients with peripheral symptoms only will be performed in selected centres (centres already indicated whether this will be possible).
  • MRI results will be taken as provided by the local centre (either read by the radiologist or rheumatologist, whoever has greater experience). Results will be categorized into 'presence or absence of active inflammatory lesions compatible with SpA', and 'presence or absence of chronic lesions compatible with sacroiliitis/spondylitis'. (Selected centres will be invited to send us their MRIs for validation of locally performed readings (the intention is to increase the quality of data).
  • Plain radiographs of the SI joints and lumbar spine are mandatory in all patients with undiagnosed chronic back pain. Previously taken radiographs are acceptable if they are not older than 6 months. Results are taken as provided locally either by the radiologist or rheumatologist, whoever has greater experience.
  • At the end of the diagnostic work up, a preliminary diagnosis must be made by the ASAS rheumatologist as is done in usual daily clinics. It is not important to be absolutely confident about the diagnosis at this stage since this i) reflects daily practice, and ii) the level of confidence with the diagnosis will be assessed as well. (It is more important to include all patients consecutively in your centre in order to avoid any selection bias.) The senior ASAS member should supervise other physicians experienced in SpA in her/his department who participate in the study.
  • Patients with peripheral symptoms should be included if they meet the inclusion criteria. Patients with peripheral symptoms and a history of chronic back pain or with concomitant chronic back pain must undergo radiographic examination of the SI joints. Patients with non-specific musculoskeletal pain or arthralgia (without arthritis) only cannot be included.

Data documentation:

The results of the clinical history, physical examination, blood tests, radiographs, and MRIs, and the diagnosis will be entered into the CRF locally by the ASAS member during/after the diagnostic work-up. The diagnosis will be made by the local rheumatologist (ASAS member or an experienced colleague at the centre). The completed CRF should be sent to the coordinating centre (Berlin) for data check and data entry. A copy of the CRF should remain locally at the study centre. The name, date of birth, address, and telephone number must also be kept locally in the centre since follow-up assessments after 2 years and after 5 years are planned.

Sample size and inclusion period:

It is estimated that about 400-500 patients with SpA (ca 250-300 axial and 150-200 peripheral SpA) with complete data sets are needed to allow for a reliable comparison of new candidate criteria with established criteria. Since the prevalence of SpA among newly referred patients with unclear diagnoses varies from centre to centre any calculation of the control group size (and thus total sample size) is bound to be inaccurate. Therefore, the proposal is that each centre recruits as many consecutive patients as possible until indicated by the study coordinators to stop inclusion. The study coordinators can adequately terminate the inclusion period only if the completed CRFs are sent within a reasonably short period of time (< 2 weeks) to the coordinating centre. Data entry and data analysis will be done at the coordinating centre.

DNA/RNA-analysis and biomarker analysis:

In addition to the clinical study which aims to arrive at new classification and diagnostic criteria, two groups of researches will perform laboratory experiments in patients from selected centres: Genetic polymorphisms and gene products (RNA) which are potentially associated with spondyloarthritis will be analysed by Prof. Matthew Brown in Brisbane, Australia. A second group of researchers (Prof. Walter Maksymowych, Canada, Prof. Mikkel Ostergaard, Denmark, Prof. Rob Inman, US, and Prof. David Yu, US) will analyse several biomarkers such as cartilage break-down or bone formation proteins in serum and/or plasma. Data from both experimental projects may be of potential diagnostic value in the future and/or may reveal novel insights into pathophysiological mechanisms of spondyloarthritis.

Longterm follow-up:

A second follow-up visit of all patients 2 years after the first encounter and also 5 years after the first encounter is highly warranted since diagnoses may change over time and the final diagnosis after long-term follow up is the most important gold standard. Thus, a record containing the names, addresses, and phone numbers of all patients included in the study must be stored locally at the study site. The patient is best informed at the first visit that a follow-up assessments 2 and 5 years later are envisaged.

Study Type

Observational

Enrollment (Anticipated)

992

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Gent, Belgium, B-9000
        • Recruiting
        • University Hospital Gent
        • Contact:
        • Principal Investigator:
          • Filip van den Bosch
  • Brazil
      • Sao Paulo, Brazil
        • Not yet recruiting
        • Rheumatology Division
        • Contact:
        • Principal Investigator:
          • Rozana Ciconelli
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 252
        • Recruiting
        • University of Alberta
        • Contact:
        • Principal Investigator:
          • Walter Maksymowych, MD
    • Ontario
      • Toronto, Ontario, Canada, ON M5T 2S8
        • Not yet recruiting
        • The Toronto Hospital
        • Contact:
          • Robert Inman, MD
        • Principal Investigator:
          • Robert Inman, MD
  • China
      • Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Feng Huang, Prof.
      • Guangzhou, China, 510630
        • Recruiting
        • Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Jieruo Gu, MD
  • Colombia
      • Bogota, Colombia
        • Recruiting
        • Division of Rheumatology
        • Contact:
        • Principal Investigator:
          • Rafael Valle-Oñate
  • Denmark
      • Hvidovre, Denmark, 2650
        • Recruiting
        • Hvidovre Hospital, University of Copenhagen
        • Contact:
          • Mikkel Ostergaard, Prof.
          • Phone Number: 3286 0045 3632
          • Email: mo@dadlnet.dk
        • Principal Investigator:
          • Mikkel Ostergaard, Prof.
  • France
      • Marseille, France
        • Not yet recruiting
        • Service de Rheumatologie
        • Contact:
        • Principal Investigator:
          • Thao Pham
      • Paris, France, 75014
        • Recruiting
        • Rheumatology B Department
        • Contact:
        • Principal Investigator:
          • Christophe Hudry, Dr.
  • Germany
      • Berlin, Germany, 12163
        • Recruiting
        • Brandt
        • Contact:
        • Principal Investigator:
          • Jan Brandt, PD Dr.
      • Berlin, Germany, 12200
        • Recruiting
        • Universitaetsmedizin Berlin, Charité Campus Benjamin-Franklin, Med. Clinic I, Rheumatology, Hindenburgdamm 30
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin Rudwaleit, PD Dr.
      • Herne, Germany, 44625
  • Hungary
      • Budapest, Hungary, H-1027
        • Not yet recruiting
        • Géher
        • Contact:
        • Principal Investigator:
          • Pál Géher, MD
  • Indonesia
      • Semarang, Indonesia, 50241
        • Not yet recruiting
        • Seroja Rheumatic Centre
        • Contact:
        • Principal Investigator:
          • John Darmawan, MD
  • Ireland
      • Dublin, Ireland, 4
        • Recruiting
        • St. Vincent's Hospital
        • Contact:
          • Oliver Fitzgerald, Prof.
          • Phone Number: 5033 353 1 269
          • Email: ofitzger@iol.ie
        • Principal Investigator:
          • Oliver Fitzgerald, Prof.
  • Italy
      • Firenze, Italy, 50122
        • Recruiting
        • University of Florence
        • Contact:
        • Principal Investigator:
          • Marco Mattuci Cerinic, MD
      • Reggio Emilia, Italy, 422100
        • Recruiting
        • Arcispedale S. Maria Nouva
        • Contact:
        • Principal Investigator:
          • Carlo Salvarani, MD
      • Scafati (SA), Italy
        • Recruiting
        • Caterina Naclerio
        • Contact:
        • Principal Investigator:
          • Caterina Naclerio, Dr.
  • Mexico
      • Mexico City, Mexico, DF 06726
        • Not yet recruiting
        • Hospital General de Mexico
        • Contact:
        • Principal Investigator:
          • Rubén Burgos Vargas, Prof.
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Recruiting
        • VU University Medical Center
        • Contact:
        • Principal Investigator:
          • I.E. van der Horst.-Bruinsma, MD
      • HG IJmuiden, Netherlands, 1971
        • Recruiting
        • Kennemer Gasthuis, Locatie Deo
        • Contact:
        • Principal Investigator:
          • Annelies Linssen, MD
      • Maastricht, Netherlands, 6229 HX
        • Recruiting
        • University Hospital Maastricht
        • Contact:
          • Désirée van der Heijde, Prof.
          • Phone Number: 7007 0031 43 387
          • Email: dhe@sint.azm.nl
        • Principal Investigator:
          • Désirée van der Heijde, Prof.
  • Spain
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario "Reina Sofia"
        • Contact:
          • Eduardo Collantes-Estévez, MD
          • Phone Number: 1631 0034 95701
          • Email: ecollantes@ser.es
        • Principal Investigator:
          • Eduardo Collantes-Estévez, MD
      • Madrid, Spain, 28007
        • Not yet recruiting
        • Hospital Universitario Gregorio Marañon
        • Contact:
          • Carlos M Gonzáles Fernández, MD
          • Phone Number: 8571 0034 91586
          • Email: carlosmg@ctv.es
        • Principal Investigator:
          • Carlos M Gonzáles Fernández, MD
  • Switzerland
      • Zürich, Switzerland, 8008
        • Recruiting
        • Balgrist University Hospital
        • Contact:
        • Principal Investigator:
          • Ulrich Weber, MD
  • Taiwan
      • Beitou Dist. Taipei, Taiwan, 112
        • Recruiting
        • Veterans General Hospital Taipei
        • Contact:
        • Principal Investigator:
          • Chung-Tei Chou, Dr.
      • Taichung City, Taiwan, 40201
        • Recruiting
        • Wei
        • Contact:
        • Principal Investigator:
          • James Wei, MD
  • Turkey
      • Bornova, Turkey, 35050
        • Recruiting
        • Duruöz
        • Contact:
        • Principal Investigator:
          • Tuncay Duruöz, MD
      • Elazig, Turkey
        • Recruiting
        • Division of Rheumatology
        • Contact:
        • Principal Investigator:
          • Salih Ozgocmen, PhD
      • Izmir, Turkey
  • United Kingdom
      • Glasgow, United Kingdom, G31 2 ER
        • Not yet recruiting
        • Glasgow Royal Infirmary, Queen Elizabeth Building
        • Contact:
        • Principal Investigator:
          • Roger Sturrock, Prof.
      • Goodmayes, United Kingdom, IG3 8YB
        • Recruiting
        • King George Hospital
        • Contact:
        • Principal Investigator:
          • Euthalia Roussou, MD
      • Leeds, United Kingdom, LS7 4SA
        • Recruiting
        • ChapelChapel Allerton Hospital
        • Contact:
        • Principal Investigator:
          • Paul Emery, MD
  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Not yet recruiting
        • Case Western Reserve University at MetroHealth Medical Centre
        • Contact:
        • Principal Investigator:
          • Asim Muhammad Khan, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnosis of Spondyloarthritis
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Patients with a retained diagnosis of spondyloarthritis after follow-up
Time Frame: 2-5 years
2-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

May 18, 2006

First Submitted That Met QC Criteria

May 18, 2006

First Posted (ESTIMATE)

May 19, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 13, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASAS-class-crit-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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