The following is a listing from SAA of active spondylitis research opportunities, including those from third parties. SAA is not affiliated with any third party studies listed here, and is sharing them as a service to the community.
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The Children’s Hospital of Philadelphia and 20 partnering institutions across the U.S. have an exciting opportunity for patients and families impacted by Juvenile Spondyloarthritis (JSpA.)
Have you ever wondered if medications can be stopped once the disease is inactive? Or how long remission would last if you or your child stop the medication?
The BACK-OFF JSpA study was designed by researchers, doctors, parents, and patients to answer these and other questions.
Who is eligible?
The study is recruiting children and adolescents with juvenile onset spondyloarthritis who are currently doing well on a TNF inhibitor (Humira, Enbrel, Remicade, Cimzia, or Simponi.)
To be eligible, you or your children must meet the following conditions:
Study design:
Study participants will be randomly assigned to one of three groups:
The study will last 12 months and will include visits with your regular rheumatologist every three months. You’ll be asked to fill out surveys at each appointment and may have the opportunity to participate in two optional blood draws and MRI scans. Once the initial 12 months of the active study period ends, you’ll be asked to continue to fill out surveys for up to 24 additional months as follow up.
How to enroll:
Enrollment will take place at one of 21 participating pediatric healthcare systems. Ask your rheumatologist or research coordinator about signing up!
Thank you for considering taking part in the BACK-OFF JSpA Study!
The Oregon Health & Science University under the direction of Atul Deodhar, MD is recruiting patients with spondyloarthritis for an experimental study on the efficacy of terbinafine anti-fungal oral tablets for the treatment of their joint disease. Topical terbinafine ointment is available without a prescription and used to treat fingernail and toenail fungus. Oral terbinafine is only available with a prescription and used to treat more persistent or severe fungal infections. There are data to support the idea that fungi might activate the immune system to contribute to spondyloarthritis.
Study design:
The design of this study is double blind, cross over and it lasts 32 weeks. This means that half of the subjects will start out with a placebo and half will start out on terbinafine. The dose of terbinafine will be 500 mg/day which is twice what is recommended for prescription use. After 16 weeks, those who began with placebo will be switched to terbinafine and those who started with terbinafine will be switched to placebo. During the study, neither the study team nor the subject will know whether terbinafine or placebo is being prescribed. The medicine will be provided without cost.
Who is eligible to take part?
To be eligible for this study, you must:
• Be at least 18 years old.
• Be able to provide records from a physician to confirm the diagnosis of spondyloarthritis
(ankylosing spondylitis, non-radiographic axial spondyloarthritis, psoriatic arthritis, or arthritis secondary to inflammatory bowel disease).
• Not be pregnant or nursing and you must not plan to become pregnant during the 32 weeks of study.
• Not have taken any antibiotics within 3 months of starting the study.
• Agree to remain on a stable treatment regimen for your joint disease for the duration of the trial and for one month before the study begins. You can continue to take your regular medicines for spondylitis in addition to the terbinafine.
• Be willing to complete a questionnaire called the BASDAI about the severity of your disease at multiple time points throughout the study.
• Be willing to undergo blood draws throughout the study to be sure that the medicine is safe. Your insurance will be billed for routine lab tests, but the study will cover costs not
provided by insurance. These blood draws can be done at any outpatient clinical laboratory near you.
• Be willing to provide stool samples by mail. These samples will be analyzed to be sure that the medicine is killing any yeast or fungi which are normally present in stool. You will be provided instructions, collection supplies and shipping materials.
There are additional criteria in order to be eligible such as having no history of cancer, no blood
problems, and no allergy to terbinafine.
Contact:
If you would like to participate in this study, please call 503-494-5070. A study coordinator will review all of the eligibility criteria with you and provide information about the laboratory testing that needs to be done to verify your eligibility and the records that need to be provided. They can also answer any questions regarding study participation. Although the study is directed from Oregon, you can participate from anywhere in the U.S. without needing to visit Oregon.
IRB approval: #21565
Do you have chronic pain and regularly take opioid medications? Participate in the Living in Full Even with Pain Study with the University of Washington and get free, evidence-based treatment for pain. We are recruiting from across the entire United States.
Chronic pain is a significant problem affecting millions of Americans. Different types of treatment such as mindfulness meditation, cognitive therapy, and activation skills have been used to treat chronic pain in the general population with success, but little is known as to how these treatments work. The purpose of this study is to compare how these treatments work and see why these treatments are effective. In addition, we are interested in learning whether these treatments allow people to become less reliant on pain medications. This study will use videoconferencing, survey, and activity monitoring technologies.
WHAT DOES PARTICIPATION LOOK LIKE?
IMPORTANT: All study procedures are done remotely, from your own home, over the phone or Internet. There are NO in-person procedures. All three treatments are evidence-based and have been shown to benefit those with chronic pain.
Participation in the study will last approximately 8-9 months, with the majority of procedures to occur in the first 3-4 months. Compensation for completion of the phone assessments and online surveys, and the return of the activity monitor, will be provided.
Study design:
Three-group parallel design, randomized controlled clinical trial.
Who is eligible to take part?
You may be eligible to participate if you:
Other eligibility criteria apply. Please contact our study (info below) for more information. All interested participants will need to complete a phone screening to determine eligibility for this study.
Contact:
Phone: 206-221-7224 or toll-free 1-800-570-5576
Email: lifestudy@uw.edu
Website: https://sites.uw.edu/lifestudy/
IRB approval: #STUDY00006474
The Children’s Hospital of Philadelphia and 20 partnering institutions across the U.S. have an exciting opportunity for patients and families impacted by Juvenile Spondyloarthritis (JSpA.)
Have you ever wondered if medications can be stopped once the disease is inactive? Or how long remission would last if you or your child stop the medication?
The BACK-OFF JSpA study was designed by researchers, doctors, parents, and patients to answer these and other questions.
Who is eligible?
The study is recruiting children and adolescents with juvenile onset spondyloarthritis who are currently doing well on a TNF inhibitor (Humira, Enbrel, Remicade, Cimzia, or Simponi.)
To be eligible, you or your children must meet the following conditions:
Study design:
Study participants will be randomly assigned to one of three groups:
The below are observational studies recruiting pregnant women. As such, participants will not be asked to take any medications or vaccines and will not be required to change their daily routine. The researchers will interview the women, tracking their pregnancy, as well as the health of the baby.
These observational studies are being conducted by MotherToBaby, a service of the non-profit Organization of Teratology Information Specialists (OTIS). These studies will collect information from pregnant women during their pregnancies, as well as about the baby’s health after delivery.
These studies are overseen and monitored by the Institutional Review Board (IRB) of the University of California, San Diego.
Understanding the Effects of Ankylosing Spondylitis and Psoriatic Arthritis in Pregnancy
Study Requirements:
To enroll and obtain further information about the two different studies please visit the below page applicable to you:
You will also find these studies listed on Clinical Trials here.
Understanding the Effects of Medication taken during in Pregnancy
Many women need to take medication during pregnancy to properly manage their health. Researchers are currently recruiting participants to help better understand the effects of the following medications; certolizumab pegol (Cimzia), apremilast (Otezla), and ustekinumab (Stelara) in pregnant women.
Study Requirements:
To enroll and obtain further information about the two different studies please visit the below page applicable to you:
You will also find these studies listed on Clinical Trials here.
Researchers at the Spondyloarthritis Research Program at University of California, San Francisco (UCSF) are looking to identify and compare the gut bacteria of children of ankylosing spondylitis parents.
The study aims to identify gut bacteria that may lead to the development of the disease. The study is funded by a grant from the Spondylitis Association of America, and com-pensation (of $50) is offered for your time.
You may be eligible to participate if:
Study Visit Details:
The study requires one visit to UCSF that lasts approximately 1 hour. During the visit, we will ask questions regarding you and your children’s medical history and your chil-dren will be examined by a Pediatric-Rheumatologist. We will collect saliva samples in clinic. You will be provided stool kits to take home and we will provide you with labels to have stool specimens shipped at our expense.
Study Location:
University of California, San Francisco
Arthritis and Rheumatology Clinic
400 Parnassus Avenue
Floor B1, Suite A095
San Francisco, CA 94541
Compensation:
You will be given a check for $50 upon receipt of each stool specimen.
Contact Information:
If you are interested in participating in this study or learning more about it, please con-tact Dr. Lianne Gensler’s research coordinators:
Henna Sawhney henna.sawhney@ucsf.edu**
Maria Castillo maria.castillo@ucsf.edu**
Office Ph: (415) 353-2497 Mon-Fri, 8:30am – 5pm
**e-mail correspondence is preferred, and offers direct contact with study team!
Research plays an important role in advancing our understanding of clinical care and helps lead to improvements in health. UCSF recruits patients to participate in these re-search studies. Participating in research is voluntary. It won’t affect your treatment if you inquire about the study or decide not to participate.
Study PI: Lianne Gensler, MD
IRB Approval: UCSF IRB study #18-26078 – Approved 10/31/2018
Researchers at Boston University are conducting a survey to help learn about how people with ankylosing spondylitis and related conditions choose medications. The survey will take 15-20 minutes to complete. Those who finish the survey may win one of five $50 gift cards.
You may be eligible to participate if:
This study will help researchers understand what is important to people with spondyloarthritis in choosing between medications. Once many people have shared their opinions, the results will be used to summarize the overall pros and cons of different medications. We hope the results of this study will make it easier for people with spondyloarthritis to gain access to medications that work well, and fit with each persons’ preferences.
Study PI: Dr. Maureen Dubreuil
IRB Approval: Boston University (H-34259)
For more information, and to take this survey, please visit SpondMedSurvey.
Please, contact Dr. Dubreuil at 617-353-8667 with any questions or concerns about this survey. You may also call 617-358-5372 or email medirb@bu.edu to talk with someone at the Boston Medical Center and Boston University Medical Campus IRB.
Note: Dr. Dubreuil received the SAA/Bruckel Early Career Investigator Award in SpA in 2018. Learn more here.
(The IRB is a group that helps monitor research. You should call or email the IRB if you want to find out about your rights as a research subject or if you wish to talk to someone who is not part of the study about your questions or concerns.)
This study will evaluate the natural history of spondyloarthritis (SpA) in children and adults. Researchers will study early signs and symptoms of axial spondyloarthritis to better understand the cause and progression of this disease, and in addition, compare genetic data of patients with that of healthy family members’ to help identify the genes involved in SpA, and their functions.
Successful completion of these combined analyses will allow rheumatologists to better recognize early SpA with axial involvement, particularly in children, and improve our understanding of disease cause, mechanisms involved, and progression.
Participants enrolled in this study will undergo physical examination, imaging studies, have family history taken, as well as have laboratory evaluations completed. Participants may also be evaluated for SpA related symptoms outside the joints and spine, as needed.
You may qualify to participate if you:
Study Design (What you can expect as a participant)
For more information, visit The Clinical Trials Study Page.
The study is sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
Study location:
National Institutes of Health Clinical Center
9000 Rockville Pike
Bethesda, Maryland 20892
For more information, or to enroll, please contact
April Brundidge, R.N. (301) 443-5407 brundidgea@mail.nih.gov
Robert A. Colbert, M.D. (301) 443-8935 colbertr@mail.nih.gov
Note from SAA: We are delighted to inform you of this study led by Dr. James Rosenbaum, current member of SAA’s Medical and Scientific Advisory Board.
Recent scientific studies have shown that the bacteria and other organisms which normally reside in our gut can have a profound effect on the immune system and inflammatory disease. This study will analyze gut microbe data to determine if there are patterns or certain associations with ankylosing spondylitis or HLA-B27.
Participants will be asked to complete a questionnaire, keep a 2-day food diary and to provide a sample of feces (stool) which can be collected at home and shipped to our research laboratory. An optional sample of saliva may also be provided. There are no costs for participation and all sample packaging and shipping materials are provided. If you choose to be in the study, you will not personally benefit, but may help to benefit patients with ankylosing spondylitis in the future.
For more information, please contact Dr. Rosenbaum’s research team at 503-494-5711 or B27microbiome@ohsu.edu. Thank you!
Oregon Health & Science University
PA: James Rosenbaum, MD
IRB# 8466
Relationship between HLA B27, disease status and gut microbes (An extension study of “Influence of HLA B27 status and colonoscopy bowel prep on the gut microbiome in conjunction with analysis of the gut microbiome along the gastrointestinal tract”)
Have a spondylitis research study you’d like to let us know about? Contact us at Research@spondylitis.org
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