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.

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


 

Contribute to Ankylosing Spondylitis Research with a One-time Blood Donation

This is a pre-clinical* research study with the goal of identifying biomarkers such as genetic, environmental, and microbial factors in the blood of adults with ankylosing spondylitis in order to determine what may influence the disease's development.

Participation in this at-home study is voluntary and requires a simple one-time blood donation. If you decide to participate, a mobile medical professional will work around your schedule to come to you and perform the blood draw. The study’s findings may help lead to new diagnostic or treatment options for those living with ankylosing spondylitis.

Participants will be compensated $50 for their time.

You may qualify to participate if you:

  • •  Are over the age of 18.
  • •  Have been diagnosed with Ankylosing Spondylitis
  • •  Live within 4-5 hours of Summit, NJ

Visit https://sanguinebio.com/study?name=AnkylosingSpondylitis to sign up, or call (818) 804-2465 to speak with a research coordinator and see if you qualify.

Sanguine Biosciences, Inc.
PI: Houman Hemmati MD
QR IRB#: 28367/1

Official Study Title: “A Multi-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives”

*What is preclinical research? In preclinical research, researchers test their theories on human samples like blood rather than human participants. This phase helps researchers determine the safest and most effective way to move forward with their project and often helps define the parameters of future clinical trials.

How will my blood donation help? Researchers will always rely on samples from the patient population that they are researching in order to perform their preclinical research. Your blood could be key to new therapies and diagnostics. Without it, researchers cannot move forward with their clinical tests and research projects are stalled or put on hold.


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.


Clinical Trial Opportunity for Adults with Ankylosing Spondylitis

A phase 2/3 clinical trial is now recruiting patients over the age of 18 with active ankylosing spondylitis (AS) to participate in a study evaluating the safety and efficacy of Upadacitinib (ABT- 494) - a JAK inhibitor medication taken orally.

The purpose of the trail, titled, “A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis” is to investigate the effectiveness, impact and performance of Upadacitinib by comparing the perceived symptomatic improvements in pain, global assessment, function, and inflammation experienced with Upadacitinib versus a placebo (a mock medication with no therapeutic effects.)

Study qualifications include:

  • •  Age 18-99.
  • •  Have a clinical diagnosis of ankylosing spondylitis.
  • •  Have experienced an inadequate response to at least two Nonsteroidal Anti-Inflammatory Drugs (NSAIDs).
  • •  Have had no exposure to any biologic medications used for spondyloarthritis.

More information can be found on the Clinical Trials website.

This study is sponsored by AbbVie, who has created a promotional website for the study. You’ll find additional information and a qualification questionnaire at http://clinicalresearchstudy4as.com/.

For location of study centers, you can call (847) 283-8955, email abbvieclinicaltrials@abbvie.com or visit the clinical trials study locations page.


Treatment Decision Making in Ankylosing Spondylitis (AS)

The Cedars-Sinai Division of Rheumatology and Center for Outcomes Research and Education are hoping to better understand what matters most to AS patients in selecting an AS medication. This is an online survey and should take about 15 minutes to complete.

This survey is part of a research study conducted by Dr. Brennan Spiegel at Cedars-Sinai Medical Center, and sponsored by Novartis Pharmaceuticals.

Learn more and take the survey here


Clinical Trial Opportunity for Adults with Non-radiographic Axial Spondyloarthritis (nr-axSpA)

A phase 3 clinical trial is now recruiting non-radiographic axial Spondyloarthritis (nr-axSpA) patients over the age of 18 to participate in a study of an investigational biologic medication, secukinumab, given by injection.

You may qualify to participate in this study if you:

  • • Are 18 years of age or older
  • • Have been diagnosed with nr-axSpA
  • • Have no radiographic evidence of changes in the sacroiliac joints
  • • Have had little or no relief from prescription anti-inflammatory medications
  • • First experienced symptoms before age 45
  • • Have had inflammatory back pain for at least six months

Additional requirements apply.

If you qualify and agree to be in the study, you will receive the investigational study medication and all study-related care at no cost. Participation is expected to last approximately 24 months.

The purpose of the trial, entitled the “Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis,” is to evaluate the safety, tolerability, and effectiveness of the injected investigational study medication, secukinumab, in helping to decrease the frequency and severity of spondyloarthritis symptoms.

More information can be found at https://clinicaltrials.gov/ct2/show/NCT02696031?cond=NCT02696031&rank=1

This study is sponsored by Novartis Pharmaceuticals. For location of study centers near you, you can contact them at 1-888-669-6682 and ask for NCT02696031.

Learn more about participating in Clinical Studies.


 

 

Clinical Trial Opportunity for Adults with Axial Spondyloarthritis (Ankylosing Spondylitis)

A phase 3 clinical trial is now recruiting axial spondyloarthritis (ankylosing spondylitis) patients over the age of 18 to take part in a three-pronged study. The investigational study medication is an IL-17 inhibitor called Ixekizumab.

Eli Lilly and Company, who is the drug manufacturer and is sponsoring the study, has created a website where you can learn more, and prescreen for each of the studies. See “Find a Lilly Trial.”

The three related studies can also be found through ClinicalTrials.gov, linked below:


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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