Clinical trial NCT00726765: Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain (Study P05320)(COMPLETED)
Official title: Observational Trial on the Value of Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Spondyloarthropathies
Axial Spondyloarthritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-01
Enrollment: 1090
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine which of two referral strategies, when used by referring physicians, is superior in the diagnosis of AS by rheumatologists.
timeFrame: Approximately 3-6 months
Secondary outcomes:
measure: 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.
timeFrame: Approximately 3-6 months
measure: To describe the demographics and disease characteristics of patients diagnosed with AS.
timeFrame: Approximately 3-6 months
measure: To compare patient-derived data with physician data to determine whether the former alone can serve as effective screening for AS.
timeFrame: Approximately 3-6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Sieper J, Srinivasan S, Zamani O, Mielants H, Choquette D, Pavelka K, Loft AG, Geher P, Danda D, Reitblat T, Cantini F, Ancuta C, Erdes S, Raffayova H, Keat A, Gaston JS, Praprotnik S, Vastesaeger N. Comparison of two referral strategies for diagnosis of axial spondyloarthritis: the Recognising and Diagnosing Ankylosing Spondylitis Reliably (RADAR) study. Ann Rheum Dis. 2013 Oct;72(10):1621-7. doi: 10.1136/annrheumdis-2012-201777. Epub 2012 Oct 13.