Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain (Study P05320) - Full Text View

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00726765

Purpose

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.

Condition
Spinal Spondyloarthropathies Axial Spondyloarthritis

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Observational Trial on the Value of Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
To describe the demographics and disease characteristics of patients diagnosed with AS. [ Time Frame: Approximately 3-6 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	June 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
Referral Strategy 1 Patient meets at least one of the following three criteria: Inflammatory back pain Human leukocyte antigen B27 (HLA-B27) Sacroiliitis demonstrated by imaging (X-ray, magnetic resonance imagining [MRI], bone scan [if previously available])
Referral Strategy 2 Patient meets at least two of the following six criteria: Inflammatory back pain HLA-B27 Sacroiliitis (on imaging) Family history of AS Good response of back pain to nonsteroidal anti-inflammatory drugs (NSAIDs) Known Extra Articular Manifestations (Uveitis, Iridocyclitis, Psoriasis, Inflammatory Bowel Disease)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726765

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

United States, New Jersey
Coordinating Location	Recruiting
Kenilworth, New Jersey, United States, 07033

Sponsors and Collaborators

Schering-Plough

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05320
Study First Received:	July 30, 2008
Last Updated:	November 4, 2009
ClinicalTrials.gov Identifier:	NCT00726765 History of Changes
Health Authority:	United States: No HA is involved as no treatment is involved.

Additional relevant MeSH terms:

Spinal Diseases
Joint Diseases
Nervous System Diseases
Low Back Pain
Pain
Back Pain
Bone Diseases

Signs and Symptoms
Musculoskeletal Diseases
Arthritis
Neurologic Manifestations
Spondylarthritis
Spondylarthropathies

ClinicalTrials.gov processed this record on November 30, 2009