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

Axial Spondyloarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726765
• Other study ID #: P05320
• Status: Completed
• Phase: N/A
• First received: July 30, 2008
• Last updated: January 20, 2016
• Start date: June 2008
• Est. completion date: May 2010

Study information

• Verified date: January 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No HA is involved as no treatment is involved.
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1090
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Low Back Pain
• Spinal Spondyloarthropathies
• Spondylarthritis
• Spondylarthropathies
• Spondylitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Sieper J, Srinivasan S, Zamani O, Mielants H, Choquette D, Pavelka K, Loft AG, Géher P, Danda D, Reitblat T, Cantini F, Ancuta C, Erdes S, Raffayová 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	To describe the demographics and disease characteristics of patients diagnosed with AS.		Approximately 3-6 months	No
Secondary	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	No