No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
2 – 99
Sex
Any
Study type
Observational
Participants needed
2,000 (estimated)
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · NIH
Who this trial is looking for
This trial is looking for people diagnosed with spondyloarthritis and their healthy relatives. Participants will undergo tests to help understand the condition better, but no treatment will be provided.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with spondyloarthritis.
I am a healthy relative of someone with spondyloarthritis.
I am at least 6 years old.
I can provide consent for participation.
You may not be able to join if
I have a medical condition that may confuse the study results.
I am unable to attend follow-up visits.
I am under 2 years old.
I do not have a parent or guardian to provide consent if I am a minor.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
* Subjects with known or suspected SpA.
* Family members of individuals with known or suspected SpA.
* 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.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility 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 suspect…
* 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:
* In the case of minors, unavailability of a parent or guardian to provide informed consent.
* 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.
Fecal Microbiota Study
INCLUSION CRITERIA:
1. Subjects must be enrolled on another NIH natural history protocol, including either 14-AR-0200 (Studies on the Natural History, Pathogenesis and Outcome of Idiopathic Systemic Vasculitis, P. Grayson PI); 18-AR-0081 (Investigation of the Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still s Disease and Related Inflammatory Conditions, M. Ombrello PI), or 94-E-0165 (Studies in the Natural History and Pathogenesis of Childhood-Onset and Adult-Onset Idiopathic Inflammatory Myopathies, Lisa Rider PI), and meet the respective protocol s criteria for a diagnosis of systemic vasculitis, systemic juvenile idiopathic arthritis, or dermatomyositis.
2. Subjects with definite SpA enrolled on 11-AR-0223 are eligible for the Fecal Microbiota sub-study.
3. Healthy volunteers and pregnant people enrolled on the above protocols are also eligible.
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, expose subjects to more than minimal risk, or confuse the interpretation of the study.
3. Subjects (including healthy volunteers) less than 4 years of age are excluded due to the challenging practical considerations of collecting stool samples, and because spondyloarthritis is much less common in this age group.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.