Understanding the natural progression of spondyloarthritis
Studies on the Natural History and Pathogenesis of Spondyloarthritis
This study looks at how spondyloarthritis develops over time in both kids and adults to see if certain signs can help predict who might get more severe symptoms later on.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 2 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01422694 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the natural history of spondyloarthritis (SpA) in both children and adults. It will involve screening participants with SpA and their healthy relatives to identify symptoms and medical tests that may predict the risk of developing more severe forms of the disease. Participants will undergo physical exams, imaging studies, and biomarker assessments to evaluate the signs and symptoms associated with SpA. The study seeks to establish a cohort for future research on treatment options and disease mechanisms.
Who should consider this trial
Good fit: Ideal candidates include individuals of any age diagnosed with spondyloarthritis and their healthy relatives aged six years and older.
Not a fit: Patients who do not have spondyloarthritis or its related symptoms will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification of patients at risk for severe spondyloarthritis, enabling earlier intervention and improved management.
How similar studies have performed: While there have been studies on spondyloarthritis, this specific approach focusing on the natural history and familial aspects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 old. The vast majority of minors with SpA or suspected SpA will be 6 years of age or older. However, it is possible that children younger than age 6 will be evaluated. If children under age 6 are referred for evaluation, we will ensure that they do not have any acute or chronic comorbidity that would preclude them from being safely evaluated at the NIH Clinical Center. Such patients would be referred to other appropriate pediatric hospitals. Based on estimates of the incidence and prevalence of SpA in the pediatric and adult populations we set the accrual ceiling up to 2000. We hope to enroll up to 100 patients per year.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Sahar Lotfi-Emran, M.D. — National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study coordinator: Sahar Lotfi-Emran, M.D.
- Email: NIAMSSpA@nih.gov
- Phone: (240) 205-2837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.