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

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.

Completed

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Key information

Conditions

Spinal Spondyloarthropathies Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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
To describe the demographics and disease characteristics of patients diagnosed with AS.

Time frame: 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.

Time frame: Approximately 3-6 months

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Aug 1, 2008
Registry last updated: Jan 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed