Conquering Sjogren’s: Follow us on our journey to change the face of Sjogren’s

What You Need to Know About Sjögren’s Clinical Trials

Posted on Tue, Jun 13, 2017

clinical trial.jpgClinical trials are a crucial element in medicine and health care to help develop drugs that will treat or possibly cure certain diseases. Researchers use clinical trials to test if a drug works, how well it works, how safe it is and how it compares to any currently available treatments.

Before a drug can be tested on human patients, it is tested for years in labs. Clinical trials are among the final steps of the drug development process. When drugs are brought to clinical trials, pharmaceutical companies must find enough patients to participate in the research in order to get solid results. The rarer the condition, the more difficult it can be to find the number of patients needed for a trial.

Considerations for Participating in a Clinical Trial

If you have been diagnosed with Sjögren’s and are thinking about participating in a clinical trial, there are several factors you should consider. You can learn about trials taking place in your area on the Sjögren’s Syndrome Foundation’s website by clicking here. When researching details of potential trials that might work for you, find out the risks and benefits of each trial, ask if there are any costs that you may be responsible for associated with participation, and most importantly, talk to your doctor about whether or not the trial is right for you.

One specific consideration for participating in a Sjögren’s study is your diagnosis. In some cases, the diagnostic criteria in the study protocol may be different than the criteria your doctor used in your diagnosis.

Clinical trials can help patients gain access to new drugs and expert medical care, while contributing to important medical research benefiting the larger community. However, patients should not enter a clinical trial without considering the risks and costs to themselves as well – the medication might not work, or might have unpleasant side effects; the time and travel to the study site, time for study visits and absences from work might be costly; and once the trial is complete, the treatment may still need to undergo months of approvals before you can have regular access to it. Additionally, as a patient in a clinical trial, you may receive a placebo drug or therapy instead of the new treatment being studied. Even if you are a patient receiving a placebo, you will still receive basic standard of care and medical oversight for your condition.

How do Clinical Trials Work?

Clinical trials vary greatly depending on the type of study and the treatment being tested. Each trial is usually funded, or sponsored, by a pharmaceutical company, academic research center, or federal agencies such as the National Institutes of Health (NIH). Studies take place across the U.S. and even globally, at hospitals, physician offices, clinics and more – one study might have researchers conducting the trial in many different locations.

Prior to enrolling, you should know how long the study is expected to last, where you will need to go and what you will need to do in order to participate, how your participation will be compensated for – or if you will be compensated for your participation and more. These questions can be answered during discussions with the doctor or staff running the study. If you are still interested in participating, the study staff will usually schedule a screening visit. The details of screening appointments varies from study to study, but all screening appointments are used to determine your eligibility for the trial. Depending on the therapy being studied, screening appointments might look to learn your medical history; run blood, urine or tissue samples; and learn what medications you are currently taking.

Following the screening, the team running the study will contact you to let you know if you qualify for the trial or not. If you do qualify, you will be scheduled for your first study visit, which will help establish the baseline of your participation in the study. Again, the specifics will vary in each trial, but the doctor might run tests or draw labs, as well as give you the drug being studied and instructions for dosing and any reporting you may need to do. This first visit will also give you a chance to schedule future visits.

Throughout the duration of the study, you will need to attend appointments at various intervals. Some studies require regular visits or even hospital stays, while others can be done less frequently. As a study progresses, you may need to be seen less frequently. At each visit, the doctor may re-run tests or labs to compare against the baseline. You also may be given more medication at each visit.

When the study comes to an end, you will need to turn in any unused medication and reporting documents. The doctor will perform tests, labs or procedures similar to what was done during your screening or baseline appointments to see if the drug has made an impact on your health. The doctor may be able to tell you what treatment you received during the study once the study is complete. Once the clinical trial is completed, you will need to revert to your previous physician, if different, and treatment schedule.

Deciding to join a clinical trial can be a difficult decision, but taking part can help researchers learn more about potential treatments for your condition. If you carefully consider the risks and rewards, and arm yourself with information before committing to a study, participating can be a very rewarding experience.

by Kristen Snipes, Project Director at Rho, a Clinical Research Organization

This information was first printed in The Moisture Seeker, SSF's patient  
newsletter for members. 

Click here to learn more about  Sjögren’s clinical trials

Topics: Treatment, Advocacy, Clinical Trials

Thank You For a Year of Hope!

Posted on Thu, Dec 29, 2016

Dear Friends,

With the New Year approaching, we at the Sjögren's Syndrome Foundation (SSF) are proud of all that has been accomplished in the past year for Sjögren's patients. We want to share with you a few of the highlights from 2016 that were made possible by your support!

2016 highlights.jpg

CLINICAL PRACTICE GUIDELINES

CPGs.pngThe SSF has brought together clinical leaders and Sjögren’s experts in all areas of care to produce and publish the very first Clinical Practice Guidelines for Sjögren’s. These guidelines will help doctors and dentists in various disciplines to provide appropriate care to Sjögren’s patients and will ensure that patients receive the best treatment possible. There are currently three (3) different Guidelines that have been completed and published and they are:

  • Systemic Manifestations in Sjögren’s Patients
  • Oral Management: Caries Prevention in Sjögren’s
  • Ocular Management in Sjögren’s Patients

DRUG DEVELOPMENT

research.pngIn 2016, the SSF continued our lead in getting new therapies developed to help treat Sjögren’s. In the history of Sjögren's, there has never been so much interest in developing a therapeutic for Sjögren’s. There are currently nine companies that have shown an interest in developing a therapeutic for Sjögren’s. Each of these companies are looking to enter or have entered clinical trials in Sjögren’s. The SSF is actively engaged with these companies, as well as the U.S. Food & Drug Administration and other regulatory agencies, to ensure that the patient voice is captured throughout the entire drug development pipeline. This includes discussions concerning what patients want from a therapeutic to discussions about clinical trial design.

EDUCATION & AWARENESS

Anna Lopypnski .pngThe SSF continued to expand our awareness and education campaigns throughout 2016 with the goal to not only increase awareness about the disease but also encourage healthcare providers to become more educated about Sjögren’s and its numerous complications. The ways in which this was done included adding to our patient resources; introducing new educational opportunities for patients; continuing to support, train and grow the Awareness Ambassador program; hosting more than 175 support group meetings around the country and offering a superior National Patient Conference.


 

Anna Lopynski Quote .pngTHANK YOU!

We at the SSF are grateful for all your support and what you have helped us achieve this past year, but we are most proud of each and every Sjögren's patient as they inspire and amaze us in their fight against this disease.

As 2017 quickly approaches, we know you have many options when it comes to your year-end giving. That is why we would be extremely grateful if you were to help us reach our goal of raising $12,000 by 12 midnight on December 31st by making a donation today to the Sjögren's Syndrome Foundation.

Your gift will provide critical funds to further our research, education and awareness efforts as well as help make a difference in the lives of all Sjögren's patients. We are truly thankful for every gift we receive.

Together, we can transform the future of Sjögren’s!

Make a Donation Now

Topics: Sjogren's, Research, Clinical Trials, Clinical Practice Guidelines

Proud to be Your New Chairman!

Posted on Mon, Sep 26, 2016

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I am honored to be the new Chair of the Sjögren’s Syndrome Foundation’s (SSF) National Board of Directors. Having served on the Board for the past five years, I have seen first-hand the incredible work being done by the SSF and the impact the Foundation has made on the lives of those living with Sjögren's.

As a practicing optometrist for thirty years, I have had the pleasure of holding leadership positions in numerous community and professional eye care organizations. With all this experience, I can confidently say that there is something truly different about the SSF. The CEO, Steven Taylor, has built an organization in which the volunteer board and the professional staff work together in an efficient and cooperative way. He has engaged hundreds of volunteers from across the country to help increase awareness, raise funds, lead events and promote the work of the SSF. He has established a Board that is made up of a combination of patients, family members of patients, doctors, along with others who have an interest in the disease. The SSF staff never treats their work as a job, but rather as a calling to make a difference in the lives of those struggling with this devastating disease.

The SSF works in many areas to ensure that no stone goes unturned and that every program and project is evaluated with the patient in mind! The SSF has a strong advocacy and research arm that is working with pharmaceutical companies to develop a therapeutic for Sjögren’s. Recently, the SSF held an introductory meeting with the FDA to help launch an ongoing dialogue about clinical trials for new therapeutics in Sjögren’s. In addition to this work, the SSF also has brought together professional leaders in all areas of care to produce and publish the first-ever Sjögren’s clinical practice guidelines that doctors can now use as a roadmap for how to appropriately care for Sjögren’s patients. And our strong focus on educating patients and their families can be seen by our annual national patient conference and our more than 65 patient support groups in the United States.

As Board Chair, I am honored to be representing all Sjögren’s patients. I am truly proud to be a part of this outstanding organization and hope you’ll join with me by supporting the SSF. TOGETHER, we can continue our momentum and improve the quality of life for all those who suffer with Sjögren’s!

SSF_Board.png


Click Here to  Become an SSF Member

Topics: Dry Eyes, Sjogren's, Advocacy, Research, Clinical Trials

The TIME is NOW – SSF Plans for 2016

Posted on Mon, Jan 11, 2016


ssf_logo

Happy New Year! 

As many of you know, the Sjögren’s Syndrome Foundation (SSF) has been methodically working towards making the lives of Sjögren’s patients better! Thanks to the dedication of our Board of Directors, our staff and hundreds of volunteers, the SSF has been actively working on our overall strategic plan to make Sjögren’s a household name, increase treatment options for Sjögren’s while also helping to educate healthcare professionals on how to treat and manage Sjögren’s.   

Last year was a banner year for the SSF but 2016 is already proving to be even more exciting! There is still a lot of work to be done, but we know with the help of you, our volunteers and our staff, we are going to see great strides in many areas for Sjögren’s.

The time is now and here are just some of our plans for 2016:

  • Continue to expand the SSF’s Clinical Trials Consortium (CTC) and encourage the development of therapies for Sjögren’s. The SSF’s CTC works alongside companies that have compounds/ molecules currently under review for clinical trials in Sjögren’s. We help these companies better understand the disease, our patient community and encourage them to develop a treatment. In 2016, we plan to see more than 10 clinical trials started for a Sjögren’s therapeutic that will treat the entire disease, not just one symptom! This work of our CTC has been years in the making and we are most excited about how a therapeutic will be a game changer for Sjögren’s!
  • Expand our focus of educating all healthcare providers about the severity of Sjögren’s and its numerous manifestations by attending professional conferences, speaking to healthcare organizations and utilizing the SSF’s Awareness Ambassadors to expand our reach into physicians’ offices by educating them about the SSF and our resources.
  • Work alongside the FDA to help them understand the need for Sjögren’s therapeutic and educate them about the severity of Sjögren’s.
  • Fund new and innovative research that will lead to new biomarkers, diagnostic tools and learning what causes Sjögren’s through the SSF Research Grant Program. The SSF also will work with young investigators to encourage and recognize their work, in hopes that they pursue a career in Sjögren’s.
  • Continue the peer review process for our Clinical Practice Guidelines on the systemic manifestations of Sjögren’s. Our committee of rheumatologists will continue to focus on writing recommendations for how to treat and manage the 16 systemic manifestations that we identified need guidelines. These include fatigue, joint pain, lymphoma, internal organ involvement, etc.
  • Conduct a comprehensive national patient survey to gather crucial information about the numerous complications patients experience as well as the burden of the illness and their quality of life. The SSF is partnering with Harris Polling, a division of Nielson, to develop this survey with plans of distribution in late February. The findings of our survey will help the SSF, as we represent the patient voice and advocate for all Sjögren’s suffers.
  • Further our support of patients, family and caregivers through our website, patient materials, monthly patient newsletter as well as new resources we are developing for 2016.

 And in the few short days of 2016, the SSF has already seen two major accomplishments:

So as you can see, the time is now and the SSF has big plans for 2016! The progress the SSF continues to make and the recent advancements in Sjögren's research and awareness speaks to the combined efforts of hundreds of volunteers. It is because of their willingness to share their story, attend our events, volunteer their time, donate to the SSF, we are helping to create a future of hope for all patients and their families. s_taylor_headshot-1copy-1

It will take an army to achieve our plans for 2016, so I hope you will consider stepping up and getting involved! The Time Is Now!   

Sincerely,

Steve_Sig
Steven Taylor,
SSF Chief Executive Officer

Click Here to Learn More Ways to Connect with the SSF!

Topics: Treatment, Advocacy, Research, 50in5: Breakthrough Goal, Clinical Trials

All About Clinical Trials & Sjögren’s

Posted on Mon, Dec 14, 2015

ssfA clinical trial is important because it contributes to the advancement of science. It provides the participants an opportunity to receive potential benefit from a drug, medical device or procedure or even a lifestyle change such as diet or exercise. In a clinical trial, a new medication or product may be compared to one that is currently available. A new medication may be compared to a placebo that has no active ingredients sometimes called a sugar pill. When this new application (medication or product) is studied it may not be known as to whether or not it will help. For that matter whether or not it may be harmful or not make any difference at all.

The investigators that conduct the trials attempt to determine if the medication or product works or is effective. They also attempt to determine if there will be adverse effects associated with the therapeutic intervention. In other words, is it safe for human use? With this knowledge, a determination can be made as to how the use of the product may affect the disease state for which it is being studied.

Clinical trials are designed by investigators who have special interests in particular disease states. The hope is to add medical knowledge relating to the treatment, diagnosis and prevention of diseases.

In general, clinical studies are important because they are designed to add to medical knowledge. Importantly, the results of these trials can make a difference in the care of future patients including possible family members. 

If you are interested in participating in a clinical trial, I recommend that you first talk to your healthcare professional. If their resources are limited, use the Internet and go to www.clinicaltrials.gov to start. There are many websites available. If you are eligible to participate in a clinical trial you may be one of the first to benefit from a new treatment. There are many trials ongoing in multiple disease states. 

Additional sites include:

  • The NIH Clinical Research Trials and You website provides general information on participating in clinical research, with a focus on NIH-funded research.
  • MedlinePlus is a Web-based health information service of the National Library of Medicine. 
  • FDA is responsible for ensuring the safety and effectiveness of drugs, vaccines, and other medical products. Read more about clinical trials and the drug development process on the FDA’s website. 

Good luck!

by Theresa Lawrence Ford, MD CEO & Medical Director of North Georgia Rheumatology Group, PC SSF Clinical Trials Consortium (CTC) Committee Chair

SSF Clinical Trials Consortium

The mission of the SSF Clinical Trials Consortium (CTC) is: To increase the availability and accessibility of therapies for treating Sjögren’s by:

1. Supporting and promoting objectives that facilitate the design of clinical trials through the development of:

  • Biomarkers
  • Novel diagnostics
  • Internationally-accepted classification criteria
  • Internationally-accepted outcome measures

2. Increasing industry partnerships with the SSF

3. Engaging in dialogue with government agencies that oversee therapy approval (FDA, EMA) to develop guidelines for new drug/product approval, speed approval of new therapies for Sjögren's and ultimately ensure corporate interest in drug development

As a member of the SSF, you will receive an email or mailing notifying you about any clinical trials in your area that the Foundation is aware of.

 Click here to learn more about  current Sjögren’s clinical trials! 

Topics: Sjogren's, Treatment, Clinical Trials

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