NCT00056719

Brief Summary

This study will explore how genes may influence the severity of ankylosing spondylitis, a form of arthritis that affects the spine. Patients have inflammation of the joints of the spine, which may cause the bones of the spine to fuse, resulting in difficulty performing daily activities. Patients who developed ankylosing spondylitis after age 16 may be eligible for this study. The onset of disease is dated to the first appearance of symptoms of inflammatory low back pain or restricted spinal motion. Patients with a spondyloarthropathy other than AS may not participate. Candidates will be screened with a medical history and physical examination, blood test, and review of their medical records. They will also complete a questionnaire about their disease symptoms and medical history. Those enrolled in the study will return to the NIH Clinical Center at 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after screening for examination of the joints, measurement of flexibility of the spine, and a blood test. They will also complete symptoms assessment and coping questionnaires. At the first study visit (screening visit), x-rays will be taken of the pelvis, lower back, and neck, if recent X-rays (within 1 year) are not available. These x-ray studies will be repeated on all patients every two years during the study (at 24 and 48 months after screening).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Posted

Study publicly available on registry

March 20, 2003

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 21, 2003

Completed
3 months until next milestone

Study Start

First participant enrolled

June 19, 2003

Completed
Last Updated

December 8, 2025

Status Verified

December 4, 2025

First QC Date

March 21, 2003

Last Update Submit

December 5, 2025

Conditions

Ankylosing Spondylitis

Keywords

ArthritisSpondylarthropathySpineHereditaryDisabilityNatural HistoryAnkylosing SpondylitisSpondyloarthropathySpondyloarthritisAS

Outcome Measures

Primary Outcomes (1)

  • identify genes assoc. w/ severity of AS

    identify genes assoc. w/ severity of AS

    10 years

Secondary Outcomes (3)

  • identify genetic polymorphisms of AS

  • Changes in symptoms of AS over time

  • Genetic var. in 1st degree rel. of AS pt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

identify genes assoc. w/ severity of AS@@@

You may not qualify if:

  • Participants will:
  • have been diagnosed with AS by the modified New York criteria.
  • be able to read English or Spanish
  • Potential participants will be excluded if:
  • have a spondyloarthropathy other than AS
  • are unable to provide informed consent
  • anticipate not being available or able to comply with the schedule of study visits
  • Study entry is not limited by sex or ethnic origin. Children will necessarily be excluded because spondyloarthropathy developing before age 16 is considered a form of juvenile idiopathic arthritis, and because different age-appropriate measures of functional disability and pain would be needed.
  • Participants will be recruited by physician referral and self-referral. Information about the study will be mailed to local rheumatologists and posted on the NIH website. Notices will also be sent to local chapters of the Arthritis Foundation and the Spondylitis Association of America.
  • The accrual ceiling will be unlimited. Approximately 700 patients will be enrolled from all study sites. Approximately 150 patients will be recruited at the NIH. Other sites participating in this study are Cedars-Sinai Medical Center, Los Angeles, CA; the University of California-San Francisco, and University of Texas-Houston Health Sciences Center.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Boyer GS, Templin DW, Bowler A, Lawrence RC, Everett DF, Heyse SP, Cornoni-Huntley J, Goring WP. A comparison of patients with spondyloarthropathy seen in specialty clinics with those identified in a communitywide epidemiologic study. Has the classic case misled us? Arch Intern Med. 1997 Oct 13;157(18):2111-7.

    PMID: 9382668BACKGROUND

  • Mau W, Zeidler H, Mau R, Majewski A, Freyschmidt J, Stangel W, Deicher H. Clinical features and prognosis of patients with possible ankylosing spondylitis. Results of a 10-year followup. J Rheumatol. 1988 Jul;15(7):1109-14.

    PMID: 3262757BACKGROUND

  • Amor B, Santos RS, Nahal R, Listrat V, Dougados M. Predictive factors for the longterm outcome of spondyloarthropathies. J Rheumatol. 1994 Oct;21(10):1883-7.

    PMID: 7837155BACKGROUND

Related Links

MeSH Terms

Conditions

Spondylitis, AnkylosingArthritisSpondylarthropathiesSpondylarthritis

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint Diseases

Study Officials

  • Robert A Colbert, M.D.

    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2003

First Posted

March 20, 2003

Study Start

June 19, 2003

Last Updated

December 8, 2025

Record last verified: 2025-12-04

Locations

US(1)