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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00726765
Recruitment Status : Completed
First Posted : August 1, 2008
Last Update Posted : January 21, 2016
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease
Spinal Spondyloarthropathies Axial Spondyloarthritis

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.

Study Type : Observational
Actual Enrollment : 1090 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Trial on the Value of Diagnostic Criteria in the Diagnosis of Spinal Spondyloarthropathies in Patients With Chronic Low Back Pain
Study Start Date : June 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

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)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To describe the demographics and disease characteristics of patients diagnosed with AS. [ Time Frame: Approximately 3-6 months ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00726765     History of Changes
Other Study ID Numbers: P05320
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Joint Diseases