Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain (Study P05320)(COMPLETED)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Observational Trial on the Value of Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain

Conditions
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Spinal Spondyloarthropathies, Axial Spondyloarthritis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Referral Strategy 1<br>Patient meets at least one of the following three criteria: Inflammatory back pain Human leukocyte antigen B27 (HLA-B27) Sacroiliitis demonstrated by imaging (X-ray, magnetic resonance imagining [MRI], bone scan [if previously available]) | |
| Referral Strategy 2<br>Patient meets at least two of the following six criteria: Inflammatory back pain HLA-B27 Sacroiliitis (on imaging) Family history of AS Good response of back pain to nonsteroidal anti-inflammatory drugs (NSAIDs) Known Extra Articular Manifestations (Uveitis, Iridocyclitis, Psoriasis, Inflammatory Bowel Disease) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine which of two referral strategies, when used by referring physicians, is superior in the diagnosis of AS by rheumatologists. |  | Approximately 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Approximately 3-6 months | 
| To describe the demographics and disease characteristics of patients diagnosed with AS. |  | Approximately 3-6 months | 
| To compare patient-derived data with physician data to determine whether the former alone can serve as effective screening for AS. |  | Approximately 3-6 months |