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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Spinal Spondyloarthropathies; Axial Spondyloarthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT00726765

P05320

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,090 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,090 participants in 2 patient groups

Referral Strategy 1

Description:

Patient meets at least one of the following three criteria: 1. Inflammatory back pain 2. Human leukocyte antigen B27 (HLA-B27) 3. Sacroiliitis demonstrated by imaging (X-ray, magnetic resonance imagining \[MRI\], bone scan \[if previously available\])

Referral Strategy 2

Description:

Patient meets at least two of the following six criteria: 1. Inflammatory back pain 2. HLA-B27 3. Sacroiliitis (on imaging) 4. Family history of AS 5. Good response of back pain to nonsteroidal anti-inflammatory drugs (NSAIDs) 6. Known Extra Articular Manifestations (Uveitis, Iridocyclitis, Psoriasis, Inflammatory Bowel Disease)