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Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain (Study P05320)
This study is currently recruiting participants.
Study NCT00726765   Information provided by Schering-Plough
First Received: July 30, 2008   Last Updated: November 4, 2009   History of Changes

July 30, 2008
November 4, 2009
June 2008
March 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00726765 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain (Study P05320)
Observational Trial on the Value of Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain

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.

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.

 
Observational
Cohort, Prospective
  • Spinal Spondyloarthropathies
  • Axial Spondyloarthritis
 
  • 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])
  • 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)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
1000
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: SP Clinical Trial Registry Call Center 1-888-772-8734
United States
 
NCT00726765
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
P05320
Schering-Plough
 
 
Schering-Plough
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP