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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00726765
First received: July 30, 2008
Last updated: March 5, 2014
Last verified: March 2014

July 30, 2008
March 5, 2014
June 2008
May 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
Not Provided
Not Provided
 
Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain (Study P05320)(COMPLETED)
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Spinal Spondyloarthropathies
  • Axial Spondyloarthritis
Not Provided
  • 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])
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1090
May 2010
May 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 information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00726765
P05320
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

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