| July 30, 2008 |
| November 4, 2009 |
| June 2008 |
| March 2010 (final data collection date for primary outcome measure) |
| To determine which of two referral strategies, when used by referring physicians, is superior in the diagnosis of AS by rheumatologists. [ Time Frame: Approximately 3-6 months ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00726765 on ClinicalTrials.gov Archive Site |
- To determine which of the referral criteria proposed, or which combination of referral criteria, is the most successful and workable in the diagnosis of AS when used by referring physicians. [ Time Frame: Approximately 3-6 months ] [ Designated as safety issue: No ]
- To describe the demographics and disease characteristics of patients diagnosed with AS. [ Time Frame: Approximately 3-6 months ] [ Designated as safety issue: No ]
- To compare patient-derived data with physician data to determine whether the former alone can serve as effective screening for AS. [ Time Frame: Approximately 3-6 months ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain (Study P05320) |
| Observational Trial on the Value of Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain |
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. |
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. |
| |
| Observational |
| Cohort, Prospective |
- Spinal Spondyloarthropathies
- Axial Spondyloarthritis
|
| |
|
|
| |
| |
| Recruiting |
| 1000 |
| March 2010 |
| March 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- A subject must have back pain of unknown origin, of more than 3 months' duration, and with onset before age 45.
- A subject must be willing to give written informed consent and be able to adhere to visit schedules.
Exclusion Criteria:
- Established diagnosis of spondyloarthropathies at the time of referral.
- Any clinically significant condition or situation, other than the condition being studied, that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
|
| Both |
| 18 Years and older |
| No |
| Contact: SP Clinical Trial Registry Call Center |
1-888-772-8734 |
|
|
|
| United States |
| |
| NCT00726765 |
| Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| P05320 |
| Schering-Plough |
|
|
| Schering-Plough |
| November 2009 |