We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00726765
First Posted: August 1, 2008
Last Update Posted: January 21, 2016
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

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 ]
  • To describe the demographics and disease characteristics of patients diagnosed with AS. [ Time Frame: Approximately 3-6 months ]
  • 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 ]

Enrollment: 1090
Study Start Date: June 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
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
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00726765     History of Changes
Other Study ID Numbers: P05320
First Submitted: July 30, 2008
First Posted: August 1, 2008
Last Update Posted: January 21, 2016
Last Verified: January 2016

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