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 Oregon Health & Science University under the direction of Dr. James Rosenbaum 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 North America 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
Newly or maybe pregnant, or hoping for good news soon? If you are also currently taking Cimzia, consider taking part in the CHERISH Clinical Research Study!
Pregnancy can affect symptoms and possibly response to treatment, and data regarding treatment with biologics during pregnancy is limited, which leaves women and physicians without objective scientific evidence regarding ideal dosing during pregnancy. This study will track participants through their pregnancy, and measure changes in blood plasma levels of Cimzia during pregnancy, and after delivery.
You may be eligible to participate in this study if you are 18 years of age or older, and you:
Learn More about this study and enroll here https://thecherishstudy.com/us/en/research-studies or by calling (877) 302-2822 toll-free.
This study is listed on Clinical Trials: A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol) – Full Text View – ClinicalTrials.gov
The study is sponsored by UCB BioPharma, SPRL.
Take part in cutting edge research studying the gut’s impact on axial spondyloarthritis, and receive a free gut microbiome analysis, personalized nutrition and supplement recommendations, as well as a $100 Visa gift card!
Viome1 is conducting a research study to understand the role of the microbiome in axSpA disease activity. The goal of this study is to better understand the molecular features of the microbiome that may contribute to axSpA flares and to determine if there are specific microbes found in the microbiome that may contribute to disease activity.
We would love for you to join us and make a difference in axSpA research!
You may be eligible to participate if:
Study Details
We will send all study material to your home for sample collection within a 7-day window. All samples will be mailed back to Viome in pre-paid mailers provided in the kits. We will send you a brief survey to collect information about your condition, which you can complete on your computer or mobile device.
What we ask of you:
Compensation
For more information, you can visit www.viome.com.
Study PI: Momchilo Vuyisich, PhD
IRB Approval: The Viome Institutional Review Board (VIRB), Policy #VIRB02/Rev. 2.0
Approved 01/08/2020
Please contact studies@viome.com with any questions or concerns about this study.
1 Viome, is a for profit microbiome wellness company that is currently conducting research on the role of the microbiome in axial spondyloarthritis disease activity.
*Not eligible to participate if you reside in New York
**These recommendations are for general health and are not intended to be medical treatment for AxSpA, which should only be done in consultation with your healthcare provider.
The Spondylitis Association of America, in partnership with members of its Medical and Scientific Advisory Board, has spearheaded research into the possible impact spondyloarthritis, and medications used for spondyloarthritis, may have on COVID-19.
Understanding the effects of spondyloarthritis, and the medications used in treating it, on COVID-19 is crucial for patients, doctors, and researchers alike. Taking part in this research will help answer critical questions for the benefit of everyone in the spondyloarthritis community.
This survey will take an estimated 10-15 minutes to complete. If you take part, you will be asked to answer the questions in this survey, and in follow up surveys every four weeks for an estimated six months. You can opt out at any time.
Precaution has been taken to protect your personal information as you answer these questions. All your responses are confidential, and your personal information will be protected. We do need your email address so that we can follow up with you. Only the survey platform will have access to your information, including your email address. SAA respects and protects our community’s privacy and does not sell personal data.
Who is eligible to take part?
What is my time commitment should I decide to take part?
This survey has been reviewed and approved by the IRB of the Oregon Health & Science University. The Principal Investigator of this study is James Rosenbaum, MD.
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
A Phase 3 clinical trial is now recruiting patients over the age of 18 with active spondylitis (AS) to participate.
The purpose of the trial, titled, “Efficacy and Safety of Tofacitinib in Subjects with Active Ankylosing Spondylitis (AS)” is to determine if Tofacitinib is safe and effective in subjects with active ankylosing spondylitis
You may qualify to participate in this study if you:
More information can be found on the Clinical Trials website.
This study is sponsored by Pfizer Pharmaceuticals. For more information you can call the Pfizer call center at (800)718–1021 or email ClinicalTrials.gov_Inquiries@pfizer.com
To submit contact information to learn of study centers near you, click here.
A phase 4 clinical trial is now recruiting patients over the age of 18 with active ankylosing spondylitis (AS) to participate in a study evaluating the clinical difference between 300 mg and 150 mg of secukinumab.
The purpose of the trial, titled, “Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis (ASLeap)” is to investigate the effectiveness, impact, and performance of different secukinumab doses by comparing the effects of 150 mg and 300 mg.
Study qualifications include:
More information can be found on the Clinical Trials website.
This study is sponsored by Novartis who has created an informational website for the study. You’ll find additional information, including qualification criteria and participating sites at Asleap.
You can also call (866) 244 – 9578, email novartis.email@novartis.com, or visit the clinical trials study locations page.
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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