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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00726765 |
Purpose
This is a multi-national, multi-site, observational study to determine which of two strategies, when used by referring physicians is superior in the diagnosis of axial spondyloarthritis (AS) by rheumatologists.
| Condition |
|---|
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Spinal Spondyloarthropathies Axial Spondyloarthritis |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Observational Trial on the Value of Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain |
| Estimated Enrollment: | 1000 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Referral Strategy 1
Patient meets at least one of the following three criteria:
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Referral Strategy 2
Patient meets at least two of the following six criteria:
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Subjects will be selected using a non-probability sampling method. For each center of excellence, the local network of referring physicians will be assigned, according to a random code in a 1:1 ratio, to use one of the two referral strategies for eligible patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Each of several participating national centers of excellence will establish a network with local primary care physicians or their equivalent who will work with the center of excellence and will provide referrals of suitable patients.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
| United States, New Jersey | |
| Coordinating Location | Recruiting |
| Kenilworth, New Jersey, United States, 07033 | |
More Information
| Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | P05320 |
| Study First Received: | July 30, 2008 |
| Last Updated: | November 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00726765 History of Changes |
| Health Authority: | United States: No HA is involved as no treatment is involved. |
|
Spinal Diseases Joint Diseases Nervous System Diseases Low Back Pain Pain Back Pain Bone Diseases |
Signs and Symptoms Musculoskeletal Diseases Arthritis Neurologic Manifestations Spondylarthritis Spondylarthropathies |