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

Completed

• Conditions: Spinal Spondyloarthropathies; Axial Spondyloarthritis

• Registration Number: NCT00726765
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-08-01
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1090

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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