An observational study in Arthritis and Spondylitis, Ankylosing, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Recruiting at 1 site in United States. Open to participants aged 2 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Observational
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:
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.
Design:
The purpose of this protocol is to study the natural history of spondyloarthritis (SpA) in children and adults. Spondyloarthritis encompasses a spectrum of immune-mediated inflammatory diseases that exhibit overlapping features, but differ from other types of inflammatory arthritis in genetic predisposition, pathogenesis, and outcome. Ankylosing spondylitis (AS), the most common form of SpA, frequently begins in an undifferentiated form with back pain and stiffness in adults, and leads to aberrant ossification and ankylosis (fusion) of the spine. In children, SpA rarely presents with back pain, but instead often begins with pain and stiffness in the hips and knees due to arthritis. Enthesitis, or inflammation where tendons and ligaments connect to bones, is more common in children. Our ability to recognize early forms of AS involving the axial skeleton, particularly in children, and our understanding of the cause and progression of this disease, is limited.
The goals of this natural history protocol are to establish a cohort of pediatric and adult patients with SpA to prospectively evaluate the signs and symptoms, magnetic resonance imaging (MRI) and X-ray findings, and bone and inflammatory biomarkers associated with axial disease. We will study pathogenic mechanisms including the role of AS susceptibility genes and their variants in causing disease, and will identify patients for possible entry into future treatment studies.
Patients enrolled in this protocol will undergo a history, physical examination, imaging studies, and laboratory evaluation. When clinically indicated, patients may also be evaluated for extra-articular manifestations such as acute anterior uveitis, psoriasis or other skin problems, and inflammatory bowel disease. Peripheral blood samples will be collected from affected patients, unrelated healthy volunteers, and in some cases unaffected family members to help identify and study the genes involved in SpA and their functions. We may ask some subjects to undergo skin biopsy or bone marrow aspiration for research purposes, or to provide a stool sample for analysis of microbiota. For some patients and family members, we may ask permission to perform whole genome or exome sequencing. Fibroblasts and/or peripheral blood cells obtained from patients will be induced to become pluripotent stem cells that can be maintained indefinitely in culture and differentiated into cell types that are relevant to pathogenesis. Successful completion of these studies will allow rheumatologists to better recognize early SpA with axial involvement, particularly in children, and will improve our understanding of disease pathogenesis.
531 studies on the registry are indexed under Spondylitis, Ankylosing; 98 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 202 across 214 observational studies indexed under Spondylitis, Ankylosing.
Browse Spondylitis, Ankylosing studies →National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is the lead sponsor of 100 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Compared within Spondylitis, Ankylosing, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Arthritis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Children and adults with spondyloarthropathies.
To be eligible for follow-up visits, patients must meet the Inclusion Criteria, but not the Exclusion Criteria. Subjects will provide and then be evaluated either in the outpatient or inpatient unit of the NIH Clinical Center.
EXCLUSION CRITERIA:
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.
Fecal Microbiota Study
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy volunteers will be recruited to serve as controls
Subjects with Other Inflammatory Diseases
Subjects with confirmed or probable SpA will be identified predominantly by physician referral.
Progression from SpA to Axial Spa and to AS
sacroiliac damage on x-ray
Time frame: 10 years
Measures of disease activity (BASDAI and ASDAS) and function (BASFI).
Time frame: ongoing
Plan to share: Undecided — It is not yet known
Started Aug 2011 (actual).
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) →