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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
In-Ho Song, MD
+49(0)30-8445
in-ho.song@charite.de
Martin Rudwaleit, MD
+49(0)30-8445
martin.rudwaleit@charite.de
Spondylitis Spondylarthritis Spondylitis, Ankylosing Spondylarthropathies
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
"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."; "16447233"; "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."; "16595519"; "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. Erratum In: Ann Rheum Dis. 2019 Jun;78(6):e59. doi: 10.1136/ard.2009.108233corr1."; "19297344"
You can take part if:
You may not be able to take part if:
This is in the inclusion criteria above
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
In-Ho Song, MD
+49(0)30-8445
in-ho.song@charite.de
Martin Rudwaleit, MD
+49(0)30-8445
martin.rudwaleit@charite.de
The study is sponsored by Charite University, Berlin, Germany
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.