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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1090 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spinal Spondyloarthropathies Axial Spondyloarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Referral Strategy 1

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 \[if previously available\])

No interventions assigned to this group

Referral Strategy 2

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)

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No