RecruitingNot Applicable

Natural History and Development of Spondyloarthritis

United States2,000 participantsStarted 2011-08-12

Plain-language summary

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....

Who can participate

Age range

2 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA To be eligible for follow-up visits, patients must meet the Inclusion Criteria, but not the Exclusion Criteria. Subjects will provide informed consent and then be evaluated either in the outpatient or inpatient unit of the NIH Clinical Center. * Subjects with known or suspected SpA. * Family members of individuals with known or suspected SpA. Family members will not be asked to submit to bone marrow aspiration or interruption of therapy. * 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. * 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. * Pregnant people with SpA are allowed to enrolled. Pregnant people will not be asked to undergo an MRI and will not be asked to submit to skin biopsy or bone marrow aspiration. EXCLUSION CRITERIA * Inability to provide informed consent or, in the case of minors, unavailability of a parent or guardian. * Presence of any medical condition that would, in the opinion of the investigators, confuse the interpretation of the study. * Unavailability, or inability to comply with the schedule for follow-up visits. * Children under the age of 2 years o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression from SpA to Axial Spa and to AS

Timeframe: 10 years

Trial details

NCT IDNCT01422694

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

Sponsor typeNIH

Study typeOBSERVATIONAL

Contact for this trial

Sahar Lotfi-Emran, M.D.

(240) 205-2837 NIAMSSpA@nih.gov

View on ClinicalTrials.gov More Arthritis trials