SCLERODERMA WILL NOT TAKE MY SMILE – World Scleroderma Day 2017

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We invite you from all over the world to post a picture/video with smiles on social medias like twitter, facebook, instagram etc with the hashtag #ScleroSmile

Scleroderma is a rare autoimmune disease that turns simple daily activities into real challenges. It is life-threatening and currently has no cure. But patient organisations are fighting back. Join us as we spread awareness and support research. We refuse to lose our smiles!

Also known as Systemic Sclerosis, scleroderma is a chronic disease of the connective tissue, immune and vascular systems, and presents a major diagnostic and management problem for patients and their physicians. Despite this, the past two years have witnessed important improvements in therapies and care. Early diagnosis is essential, and the first symptom is nearly always Raynaud’s.
Help us to keep smiling by donating to research!

The Federation of European Scleroderma Associations aisbl. (FESCA) is a focal umbrella support and advocacy organisation composed of the national scleroderma associations of 19 EU countries.

The Federation of European
Scleroderma Associations aisbl.

Download our posters and handouts

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Scleroderma app – now available for download

Throughout 2016, Project Scleroderma has been brainstorming new and innovative ways of helping the scleroderma community, in addition to the awareness component which was their first focus. Now they have officially launched the Project Scleroderma Patient Support App., in conjunction with FESCA, so that you and scleroderma patients everywhere can download this app for free at any time.

The Project Scleroderma Patient Support App, among other features, allows patients to track and chart symptoms on a daily basis and keep a running diary of notes to share with their physicians. It offers a space to interact privately and securely with other scleroderma patients, and will serve as a hub for patient resources and educational videos.

To download the app

STEP 1: Download “Mobile Health Library” available on App Store, Google Play and Kindle Fire.
STEP 2: Enter MHL app code: SCLERO

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Project Scleroderma promises to update this app continually, and add useful content on a regular basis. Its main purpose is to simplify the daily experience for scleroderma patients as they tackle everyday challenges, to help ease the emotional stress that is a part of chronic illness, and to help patients who are newly diagnosed to better navigate this new and overwhelming diagnosis.

Also included is a wellness tracker that allows patients to track their overall well-being on a daily basis, and a dosing reminder for patients to set for their medications.

The button for FESCA is in the patient resources tab, and contains the link for our Facebook and website and video. The app is completely secure, and HIPPA compliant. No information will be shared or sold. It is strictly for the benefit of the patient. We will periodically be running surveys through the app to see how people are feeling about it, and to find ways in which they can help improve it.

Both FESCA and Project Scleroderma are committed to supporting the scleroderma community in as many ways as we can, in addition to our ongoing mission to dramatically increase the global level of awareness for this disease. We hope that this app will truly help scleroderma patients from every part of the world to simplify their experience and to connect with others who are battling this disease.

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Press Release – Orphan Drug Designation Granted to Nintedanib for Treatment of Systemic Sclerosis, including Associated Interstitial Lung Disease

Today, Boehringer Ingelheim sent out a press release, announcing that, “… the European Commission (EC) and U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to nintedanib for the treatment of systemic sclerosis (SSc, also known as scleroderma), including the associated interstitial lung disease (SSc-ILD)”.

Joep Welling from Fesca says: “Scleroderma and associated interstitial lung disease have a devastating impact on the patient community, and we welcome this important news that a potential new treatment has received Orphan Drug Designation. It’s a crucial step forward in helping to address an unmet need and represents important progress for patients with this rare disease.”

Read the entire press release here: https://www.boehringer-ingelheim.com/press-release/orphan-drug-designation-granted-nintedanib-treatment-systemic-sclerosis 

2 surveys on quality of care and cross-border healthcare

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The European Patients’ Forum (EPF) is the umbrella organisation representing patient groups at European level. In order to advocate effectively for patients’ rights, we need to know what is happening on the ground. To do that, we launch surveys to collect the views and experience from patients and patient representatives from as many countries and as many diseases as possible on the topics we work on.

This summer, we have launched two surveys to collect your views on quality of care and cross-border healthcare. We would be grateful if you could take a moment of your time to answer these.

Please also circulate this information to your membership and your networks, so that we can collect as many answers as possible and ensure that the results of these two surveys will be robust.

What does quality care mean for you?

Following several years’ of involvement in EU-level discussions on healthcare policy and patient safety, EPF is now conducting a survey to explore the perceptions of patients about what matters most about “quality” of care.

  • What is the survey about? EPF will use the results to develop our future advocacy work around quality of care and patient safety, including patient-centeredness and patients’ empowerment, at EU level.
  • Who should take this survey? This survey is aimed at patient representatives: primarily individual patients, their family members or informal carers, and patient organisation representatives across the EU. You do not need in-depth knowledge or experience on quality of care to complete the survey! There are no right or wrong answers, as this survey is about your perceptions and opinions.
  • How much time will it take? This short survey consists of 20 questions, some of which have tick-box options. It should take around 30 minutes to complete.
  • Deadline: The survey is open until 30 September 2016.

Survey on cross-border healthcare

This survey, conducting by EPF in cooperation with the European Disability Forum and IF (the International Federation of Spina Bidifa and Hydrocephalus) is an opportunity to share your experience with cross border healthcare and help influence the European debate on healthcare. Results will be presented at the European Parliament.

  • What is the survey about? Cross-border healthcare refers to a kind of care in which the patient from one EU member state (where he/she is insured) uses the health services in another member state. With this survey we want to measure the impact of the cross-border healthcare directive on persons with disabilities and chronic diseases.
  • Who is the survey for? Patients, patient representatives and relatives of people with disabilities or with a chronic disease. No in-depth knowledge is required to complete the survey, questions are about experience with cross-border healthcare.
  • How much time will it take? 15 minutes only!
  • Deadline: The survey is opened until 31 August 2016

Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (Clinical trial)

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Did you know, that you can look up clinical trials on scleroderma on following sites: https://clinicaltrials.gov/ and https://www.clinicaltrialsregister.eu/

For instance you can find following trial by Genentech:

A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc) [focuSSced]

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis.

The company is looking to enroll 210 patients in the following countries: Argentina, Belgium, Brazil, Bulgaria, Canada, Croatia, Denmark, France, Germany, Greece, Hungary, Italy, Lithuania, Japan, Mexico, Netherlands, Poland, Portugal, Romania, South Africa, Spain, Switzerland, UK, and USA.

Read more here: https://clinicaltrials.gov/ct2/show/NCT02453256?term=focuSSced&rank=1

 

 

Woman and pregnancy study

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Pregnancy can be a challenging time for women with rheumatic diseases, from conception until the postpartum period. University of Nicosia in Cyprus, where medical students are in the  medical program of St George’s from the University of London, is conducting a study to analyse the most common and high-risk pregnancy complications experienced by women with rheumatic diseases.

We need  women who were diagnosed with a rheumatic disease and then had one or more children.

Your participation is extremely valuable to us! You can provide information regarding the current medical care that pregnant women with rheumatic diseases experience in Europe and this will highlight areas that require improvement.

The study is anonymous and voluntary. It has the form of a short questionnaire that should not take longer than 10 -15 minutes.

Please find the questionnaire here.
https://docs.google.com/forms/d/1LDegS0rPaQHMDkZGdQbqndr3dtRu_0LDT_4hevUGPz0/viewform?edit_requested=true

For more information about the study you can visit out website: www.pwird.com 

 

Ilianna Armata, Medical Student
St George’s University of London at University of Nicosia

J Joseph, Associate professor
St George’s University of London at University of Nicosia

Marios Kouloumas, Patient society liaison
President Cyprus League Against Rheumatism (CypLAR)

IMPRESS 2 Study: International Multicentric prospective study on PREgnancy in Systemic Sclerosis

IMPRESS 2 Study: International Multicentric prospective study on PREgnancy in Systemic Sclerosis

Patients with systemic sclerosis who are planning a pregnancy may be interested in participating in an international observational prospective study on pregnancy in women with systemic sclerosis.

SSc occurs much more frequently in women than in men. The mean age at onset of symptoms is in the early 40’s. Therefore, women have the potential to become pregnant after the onset of the disease. Since very few studies have included large numbers of pregnant patients and followed them before during and after pregnancy, a number of important questions remain open and need more extensive study. Among them are:

  • Does pregnancy alter the course of systemic sclerosis in the short term or long term?
  • Are different forms systemic sclerosis differently influenced by pregnancy?
  • Does systemic sclerosis increase the risk of pregnancy complications?
  • What are the prospects of patients with renal disease, heart or lung disease to deliver a term, healthy child?
  • Are complications of SSc more frequent during pregnancy than in the non-pregnant state?
  • What is the best treatment for complications of systemic sclerosis during pregnancy?
  • How should systemic sclerosis be monitored during pregnancy?

To answer these important questions, a study of the course of disease both in pregnant patients and in age-matched non-pregnant patients with SSc over 2 years is necessary. As a control for the pregnant patients with SSc, healthy pregnant women must be followed during their pregnancies as well.

The study is purely observational, meaning that all relevant data are collected and then analyzed, aiming to study at least 100 pregnancies in SSc women. The study design is as follows:

  • Pregnant SSc patients are studied before (when possible), during, and after pregnancy. Data are collected once before pregnancy; once in the first, second, and third trimesters, more often if disease activity requires it; at delivery and then 1 year after delivery or a flare.
  • Non-pregnant SSc patients 20-45 years old are the controls for the pregnant SSc patients and will be matched with them for age and disease type. They also constitute a pool of SSc women who might become pregnant. They show the disease course over 2 years with complications and adjustments of therapy. This can answer the question: are disease complications more or less frequent during pregnancy?
  • Healthy pregnant women are studied at the same time points of pregnancy as the pregnant SSc patients. They show the physiological changes of pregnancy both in laboratory and in clinical symptoms. These can then be separated from disease related changes/events.

Duration of the study: 2 years

Importance of the study: An international project including EU and American centres will provide sufficiently large numbers of patients to study pregnancy in this rare disease. By including two control groups, comparisons can be made between SSc pregnant and healthy pregnant women, as well as between SSc pregnant and non-pregnant SSc women. The latter comparison can detect whether pregnancy has a major influence on disease activity and prognosis of SSc. In addition, the project allows discovery of whether subsets of SSc show different complications of pregnancy or of pregnancy outcome and child health. The study will help to find the best way to monitor pregnant patients with SSc, to treat arising complications during pregnancy, and to ensure a healthy pregnancy for mother and child. Furthermore, the results will improve counselling of patients with SSc who plan a pregnancy.

Publication: The results of the study will be published in Medical Journals and will also be summarised in special articles for Scleroderma Patient Associations.

Patient involvement: Women wishing to be included in the study should specify their wishes to their doctors. If the centre in which they are followed is already included in the IMPRESS network it should be easy to collect their clinical data. If the centre in which they are followed is not yet included in the IMPRESS 2 network, we will be happy to include it. In any case a single woman may contact directly the main European investigators to arrange the easiest way to collect and record her own clinical data. At that the point (if the local centre does not have the time, capability, or even the interest in collecting the data) the main organising centres will help the local centre. For instance if the local centre has difficulty in finding the controls (healthy pregnant women) the main investigators will arrange to find in another centre the appropriate controls. Our ambitious aim is that each pregnancy occurring in a SSc woman in Europe should be offered inclusion in the IMPRESS 2 project, since we anticipate that the results of the IMPRESS  2 study will be important for all SSc women contemplating a possible pregnancy.

State of art: the study enrolment is still going on: till now 80 pregnant patients from four continents have been enrolled, and several centers sent data about 250 not pregnant fertile-age patients to find out possible matchings. 92 pregnant women agreed to participate as healthy volunteer, too.

Main European Investigators:

Monika Østensen, National  Centre of Pregnancy and Rheumatic Disease, University of Trondheim, Skippervn. 4, N-4550, Farsund, Norway monika.ostensen@gmail.com

Angela Tincani, Rheumatology, Università degli Studi di Brescia, Spedali Civili, Piazzale Spedali Civili 1, 25123, Brescia, Italy tincani@bresciareumatologia.it

Antonio Brucato, Internal Medicine, Ospedale Papa Giovanni XXIII (previously named Ospedali Riuniti) Piazza OMS 1, 24127 Bergamo, Italy albrucato@asst-pg23.it

 

Latest news from the FASST trial

www.fassttrial.com

As mentioned earlier, the FASST trial is a phase 2 clinical trial sponsored by Inventiva Pharma.

The purpose of this study is to evaluate the effectiveness and safety of IVA337 for the treatment of Diffuse Cutaneous Systemic Sclerosis.

Read latest newsletter on the research: FASST Newsletter, May2016

June 29 is World Scleroderma Day – join us in Hand in Hand for a better future

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Hand in Hand for a better future

Scleroderma is an autoimmune disease that causes severe disability and can be life threatening. It is characterized by hardening of the skin and in severe cases also affects internal organs. 2.5 million individuals world wide are diagnosed with scleroderma for which there is no cure. We call for explicit plans by governments and health policy makers at National and European level to improve the livelihood of people with scleroderma.

Download our poster here: World Scleroderma Day Poster 2016, by Fesca

Join us – go HAND IN HAND

We invite you to take a picture Hand in Hand with your camera on your mobile or tablet and share it directly with your network. You may be a patient, a family member, carer or friend.

Don’t forget to use the some of the hashtags below to see your picture appear on our social media wall at www.worldsclerodermaday.org.

#handinhand #scleroderma #worldsclerodermaday #WSD16 #WSD

Hand in Hand for a better future

Collaboration between FESCA, Scleroderma Society of Canada and Boehringer Ingelheim

In April, FESCA and the Scleroderma Society of Canada signed an agreement with Boehringer Ingelheim with the intention of working together to advance clinical research and improve awareness of systemic sclerosis (SSc) also known as scleroderma.

Called a Memorandum of Understanding, and written with the assistance and moderation of Eurordis, this agreement is not legally binding and is designed to be fully transparent to everyone. Its immediate goal is to include further patient expertise in the follow-through of a new ongoing trial called SENSCIS, which has been designed to understand if a drug approved for treatment of idiopathic lung fibrosis could also provide a benefit for patients with interstitial lung disease associated with SSc.