SpondyloarthropathyNCT00383617
Referral Recommendations for Axial Spondyloarthritis
An observational study of Spondyloarthropathy and Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to determine which of the proposed screening parameters or which combination of screening parameters perform best in daily clinical practice for making the diagnosis of axial Spondyloarthritis (SpA)in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spondyloarthropathy, Ankylosing Spondylitis, Spondyloarthritis
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2004to Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- chronic back pain with a duration of more than 3 months
- onset of back pain before age of 45 years
Who cannot join
- age younger than 18 years
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Rheumatology, Medical Clinic I, Charite Campus Benjamin Franklin, Hindenburgdamm 30
Berlin, State of Berlin, 12200
About this study
Official title: Performance of Referral Recommendations in Patients With Chronic Back Pain and Suspected Axial Spondyloarthritis
The purpose of this study is to determine which of the proposed screening parameters or which combination of screening parameters perform best in daily clinical practice for making the diagnosis of axial Spondyloarthritis (SpA)in patients with chronic low back pain.
Read the 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.
- Keywords
- pre-radiographic, screening, early diagnosis
- Medical subject headings
- Spondylarthropathies, Spondylitis, Ankylosing, Spondylarthritis, Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study startJul 2004
- Primary completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthropathyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Sieper, Charite University, Berlin, Germany
- Investigators
- Joachim Sieper, MD, Principal investigator, Department of Rheumatology, Medical Clinic I, Charité University Medicine Berlin, Campus Benjamin Franklin, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383617
- Sponsor's protocol ID
- Antragsnummer : EA4/058/05
- Status last verified
- Feb 2013
- First submitted
- 2 Oct 2006
- Last updated
- 13 Feb 2013
- Results posted
- No
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.
PubMed 15818678Sieper 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.
PubMed 15528281
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Referral Recommendations in Patients With Chronic Back Pain and Suspected Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT00383617
- Acronym / sponsor ID
- Antragsnummer : EA4/058/05
- Keywords
- pre-radiographic, screening, early diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Apr 2007 (actual)
- First posted
- 3 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine which of the proposed screening parameters or which combination of screening parameters perform best in daily clinical practice for making the diagnosis of axial Spondyloarthritis (SpA)in patients with chronic low back pain.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic back pain with a duration of more than 3 months
- onset of back pain before age of 45 years
Key exclusion criteria (1 listed)
- age younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
- Background: PubMed 15818678Rudwaleit 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.
- Background: PubMed 15528281Sieper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Sieper, MD principal investigator
Department of Rheumatology, Medical Clinic I, Charité University Medicine Berlin, Campus Benjamin Franklin, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthropathy and Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00383617, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2013.