- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00383617
Referral Recommendations for Axial Spondyloarthritis
Performance of Referral Recommendations in Patients With Chronic Back Pain and Suspected Axial Spondyloarthritis
Study Overview
Status
Detailed Description
Ankylosing spondylitis (AS) and its early form accounts for up to 5% of all patients with chronic back pain. Shortening the delay of 5-10 years between first symptoms and making a diagnosis of AS has become a challenge especially because effective treatments have become available. Easy to apply referral parameters for physicians in primary care may contribute to make the diagnosis earlier.
Methods: Orthopedists and primary care physicians were offered to refer patients with i) chronic low back pain (duration >3 months) and ii) onset of back pain at an age < 45 years to a specialized rheumatology outpatient clinic for further diagnostic work-up if at least one of the following screening parameters was present: 1) inflammatory back pain (IBP), 2) positive HLA-B27, 3) sacroiliitis as detected by imaging. The final diagnosis was made according to expert opinion.
It was analyzed, which parameters or combination of parameters performed best in making a diagnosis of axial SpA.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 12200
- Department of Rheumatology, Medical Clinic I, Charite Campus Benjamin Franklin, Hindenburgdamm 30
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- chronic back pain with a duration of more than 3 months
- onset of back pain before age of 45 years
Exclusion Criteria:
- age younger than 18 years
Study Plan
How is the study designed?
Collaborators and Investigators
Investigators
- Principal Investigator: Joachim Sieper, MD, Department of Rheumatology, Medical Clinic I, Charité University Medicine Berlin, Campus Benjamin Franklin, Berlin, Germany
Publications and helpful links
General Publications
- Rudwaleit M, Khan MA, Sieper J. The challenge of diagnosis and classification in early ankylosing spondylitis: do we need new criteria? Arthritis Rheum. 2005 Apr;52(4):1000-8. doi: 10.1002/art.20990. No abstract available.
- Sieper J, Rudwaleit M. Early referral recommendations for ankylosing spondylitis (including pre-radiographic and radiographic forms) in primary care. Ann Rheum Dis. 2005 May;64(5):659-63. doi: 10.1136/ard.2004.028753. Epub 2004 Nov 4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Antragsnummer : EA4/058/05
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.
Clinical Trials on Ankylosing Spondylitis
-
Shanghai Junshi Bioscience Co., Ltd.Sponsor GmbHRecruitingActive Ankylosing SpondylitisChina
-
AbbVieBoehringer IngelheimCompletedAnkylosing Spondylitis (AS)
-
Sun Yat-sen UniversityUnknownEarly Ankylosing Spondylitis
-
AbbVieCompletedAnkylosing Spondylitis (AS)United States, Australia, Belgium, Canada, Croatia, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, United Kingdom
-
Tongji HospitalWuhan Central Hospital; Wuhan Hospital of Traditional Chinese MedicineRecruitingAnkylosing Spondylitis (AS)China
-
Chinese University of Hong KongCompletedAnkylosing Spondylitis(AS)China
-
AbbVieCompletedAnkylosing Spondylitis (AS)Taiwan
-
Tianjin Hemay Pharmaceutical Co., LtdCompletedActive Ankylosing SpondylitisChina
-
Jiangsu vcare pharmaceutical technology co., LTDRecruitingActive Ankylosing SpondylitisChina
-
Assiut UniversityUnknownActive Sacroiliitis in Ankylosing Spondylitis