Recruiting

Observational Study

Sponsor:

Charite University, Berlin, Germany

Code:

NCT00328068

Conditions

Spondyloarthritis

Spondylarthropathy

Spondylitis, Ankylosing

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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. 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.

Conditions

Spondyloarthritis

Spondylarthropathy

Spondylitis, Ankylosing

Study ID

NCT00328068

Start date

Jul, 2006

Status verified date

Feb, 2013

Completion date

Jun, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

992 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • Diagnosis of Spondyloarthritis [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Martin Rudwaleit, MD

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

In-Ho Song, MD

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

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 252

Contacts

Walter Maksymowych, MD

780 407walter.maksymowych@ualberta.ca

Principal Investigator:

Walter Maksymowych, MD

More Information

Sponsor

Charite University, Berlin, Germany

Last update posted

Feb 13, 2013

Last verified

Feb, 2013

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Charite University, Berlin, Germany on 2013-02-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.