Participate in Spondylitis Research

The following is a listing from SAA of active third party spondylitis research opportunities. SAA is not affiliated with these studies, and is sharing them as a service to the community.

Pregnancy and Spondyloarthritis: Understanding the role of spondyloarthritis, and medications used in the treatment of spondyloarthritis, in pregnant women

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.

BY CONDITION

Understanding the Effects of Ankylosing Spondylitis and Psoriatic Arthritis in Pregnancy

Study Requirements:

  • • Must have a clinical diagnosis of Ankylosing Spondylitis and/or Psoriatic Arthritis
  • • Must be currently pregnant

To enroll and obtain further information about the two different studies please visit the below page applicable to you:

For Ankylosing Spondylitis - https://mothertobaby.org/ongoing-study/ankylosing-spondylitis/ For Psoriatic Arthritis - https://mothertobaby.org/ongoing-study/psoriatic-arthritis/

You will also find these studies listed on Clinical Trials, here: https://clinicaltrials.gov/ct2/show/NCT01797224

BY MEDICATION

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:

  • • Must have a clinical diagnosis of Ankylosing Spondylitis, Psoriatic Arthritis, and/or Crohn’s disease.
  • • Must be currently pregnant and have taken any of the following medications at any point during the pregnancy.

To enroll and obtain further information about the two different studies please visit the below page applicable to you:

For Ankylosing Spondylitis - https://mothertobaby.org/ongoing-study/ankylosing-spondylitis/ For Psoriatic Arthritis - https://mothertobaby.org/ongoing-study/psoriatic-arthritis/

You will also find these studies listed on Clinical Trials, here: https://clinicaltrials.gov/ct2/show/NCT01797224


Comparison of Gut Bacteria and Genetic Risk Assessment in Children of Ankylosing Spondylitis Patients

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:

  • • Are an adult diagnosed with Ankylosing Spondylitis (meeting modified NY criteria), and are HLA B27 positive
  • • Have biological children between the ages of 5-19 years old (with or without ankylos-ing spondylitis)
  • • Are *not* currently taking antibiotics or sulfasalazin

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


Spondyloarthritis Medication Preferences Study

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:

  • • You are 18-89 years old
  • • A doctor has diagnosed you with ankylosing spondylitis, psoriatic arthritis involving the spine, or another form of spondyloarthritis.
  • • You do not have Crohn’s disease or ulcerative colitis, two forms of bowel inflammation.

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 http://bit.ly/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.)


Natural History and Development of Spondyloarthritis

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:

  • • Have been diagnosed with a form of spondyloarthritis (no age limits.)
  • • Are a healthy relative, 6 years old or older, of someone with spondyloarthritis.
  • • Note – there is only ONE study location – in Bethesda, MD.

Study Design (What you can expect as a participant)

  • • Participants with SpA will be screened through medical records and taking of family medical histories, physical exam including a study of joint movement, blood and urine tests, completion of questionnaires about pain and quality of life, as well as imaging studies (MRI).
  • • Healthy family members of individuals participating in the study will be asked to provide a blood sample and cheek cell samples.
  • • No treatment will be provided, although treatment options will be discussed.

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


Help researchers determine best methods of measuring and tracking spinal fusion in ankylosing spondylitis

Better ways to measure spinal fusion are needed to be able to evaluate the effectiveness of medicines in slowing or stopping spinal fusion. This study hopes to answer the question of whether CT scanning of the spine can provide a reliable, valid, and sensitive measure of spinal fusion in ankylosing spondylitis. This observational study will (1) evaluate whether CT scanning is better than regular x-rays for measuring changes in the stiffness and fusion of the spine; and (2) determine if CT scanning can be used to measure the speed of extra bone formation.

Participants must be 18 years of age or older, have a diagnosis of ankylosing spondylitis, and not currently be taking a TNFi medication (etanercept, infliximab, adalimumab), nor plan to take one in the next year. Participants will be asked to schedule a total of 8 clinic visits throughout the 48-month study. The study is sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), at NIH, and has two study locations, both in Maryland.

Additional study details below:

  • • Clinical assessment will be conducted at all visits, consisting of taking medical history and a physical examination to include measurement of spinal flexibility, as well as completion of a symptoms questionnaire.
  • • Blood tests will be conducted to measure inflammation.
  • • X-rays of the pelvis, low back, and neck will be taken.
  • • CT scans of the low back will be taken.
  • • MRI of the low back will be taken.
  • • Symptoms questionnaire will be administered by mail every 4 months for a period of 2 years.
Study locations:
  1. John Hopkins University
    Baltimore, Maryland 21205
  2. National Institutes of Health Clinical Center
    9000 Rockville Pike
    Bethesda, Maryland 20892

For more information and to enroll, please contact Nancy A Spencer at (301) 827-0186 or email Nancy.spencer@nih.gov, or Michael M. Ward, M.D. at (301) 496-7263 or email wardm1@mail.nih.gov.

Please visit the clinical trials study page for additional details.


Clinical Trial Opportunity for Adults with Ankylosing Spondylitis

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:

  • • Are 18 years of age or older
  • • Have a clinical of diagnosis of Ankylosing Spondylitis (AS)
  • • Must have a radiograph of SI joints (AP Pelvis) documenting diagnosis of AS.
  • • Have active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or intolerant to NSAIDs.

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


Clinical Trial Opportunity for Adults with Ankylosing Spondylitis

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:

  • • Over the age of 18.
  • • Have a clinical diagnosis of moderate to severe ankylosing spondylitis.
  • • Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >= 4.
  • • Be on non-steroidal anti-inflammatory drugs (NSAIDs) at the maximum tolerated dose for at least 4 weeks prior to their Baseline Visit, with an inadequate response, or for less than 4 weeks if withdrawn for intolerance, toxicity or contraindications.

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 http://www.asleap.com/.

You can also call (866) 244 - 9578, email novartis.email@novartis.com, or visit the clinical trials study locations page.

Learn more about participating in Clinical Studies.


Help researchers understand the relationship between ankylosing spondylitis and gut microbes.

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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