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
  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 ] [ 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 ]

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

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
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00726765     History of Changes
Other Study ID Numbers: P05320
Study First Received: July 30, 2008
Last Updated: March 5, 2014
Health Authority: United States: No HA is involved as no treatment is involved.

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

ClinicalTrials.gov processed this record on July 20, 2014