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Protocol Details

Studies on the Natural History and Pathogenesis of Spondyloarthritis

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

11-AR-0223

Sponsoring Institute

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

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: N/A
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Sacroiliitis;
Ankylosing Spondylitis;
Spondyloarthritis;
HLA-B27;
Enthesitis-Related Arthritis

Recruitment Keyword(s)

Spondyloarthritis;
Ankylosing Spondylitis

Condition(s)

Arthritis;
Spondylitis, Ankylosing

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Background:

- Spondyloarthritis (SpA) is a group of bone and joint disorders that may cause back and joint pain and stiffness. In some cases, SpA can lead to abnormal bone growth affecting the joints and spine. Some patients have SpA without ever developing these growths, while others develop them after only a few years. Researchers are interested in studying people with SpA and their relatives to determine which people are more likely to develop more severe conditions.

Objectives:

- To identify symptoms and medical tests that can help determine whether a person with SpA is at risk for developing more severe forms of the disease.

Eligibility:

- Individuals of any age who have been diagnosed with SpA.

- Healthy volunteer relatives (at least 6 years of age) of the individuals with SpA.

Design:

- Participants will be screened with medical records and family medical histories, and will be invited to the clinical center for the study.

- Participants with SpA will have a physical exam and medical history, including a study of joint movement, blood and urine tests, and questionnaires about pain and quality of life.

- Participants with SpA will have imaging studies, including magnetic resonance imaging (MRI). Other samples such as skin tissue and bone marrow may also be collected for study.

- Healthy volunteers will provide a blood sample and cheek cell samples.

- No treatment will be provided, although treatment options will be discussed.

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Eligibility

INCLUSION CRITERIA:

Subjects with known or suspected SpA will provide informed consent and then be evaluated either in the outpatient or inpatient unit of the NIH Clinical Center. To be eligible for follow-up visits patients must meet the Inclusion Criteria, but not the Exclusion criteria. Subjects determined to not have SpA will not be followed.

Patients with signs and symptoms of SpA will be classified as outlined in #1 and #2 below (see Appendix 10.1 for Classification Criteria):

1.) Patients less than 16 years of age will be considered to have SpA if they meet the ILAR criteria for ERA (without or with psoriasis or a positive family history of psoriasis), or modified NY criteria for AS.

2.) Patients 16 years of age or older will be considered to have SpA if they have previously met ILAR criteria for ERA, or currently meet ESSG or Amor criteria for USpA, ASAS criteria for Axial SpA, or modified NY criteria for AS.

3.) Family members of individuals included under items 1 and 2. Family members will not be asked to submit to bone marrow aspiration or interruption of therapy.

4.) Controls for clinical, cellular, molecular, and biochemical assays, and genetic evaluation will be enrolled. Individuals who undergo phlebotomy specifically to provide a control specimen will be 6 years of age or older, and not pregnant.

5.) Minor healthy volunteers undergoing imaging (SI and/or WB MRI) must be old enough to complete the procedure without sedation. Generally this requires that they be at least 6 years of age, so no healthy volunteers under age 6 will be enrolled.

EXCLUSION CRITERIA:

1.) Inability to provide informed consent or, in the case of minors, unavailability of a parent or guardian.

2.) Presence of any medical condition that would, in the opinion of the investigators, confuse the interpretation of the study.

3.) Unavailability, or inability to comply with the schedule for follow-up visits.


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Citations:

Amor B, Dougados M, Mijiyawa M. [Criteria of the classification of spondylarthropathies]. Rev Rhum Mal Osteoartic. 1990 Feb;5 (2):85-9.

Dougados M, van der Linden S, Juhlin R, Huitfeldt B, Amor B, Calin A, Cats A, Dijkmans B, Olivieri I, Pasero G, et al. The European Spondylarthropathy Study Group preliminary criteria for the classification of spondylarthropathy. Arthritis Rheum. 1991 Oct;34(10):1218-27.

Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R, Kwoh CK, Liang MH, Kremers HM, Mayes MD, Merkel PA, Pillemer SR, Reveille JD, Stone JH; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008 Jan;58(1):15-25.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Robert A. Colbert, M.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
BG 10-CRC RM 1-5142
10 CENTER DR
BETHESDA MD 20814
(301) 443-8935
colbertr@mail.nih.gov

April Brundidge, R.N.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health
Building 10
Room 6N216
10 Center Drive
Bethesda, Maryland 20892
(301) 443-5407
brundidgea@mail.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01422694

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