Woman and pregnancy study

pregnant

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

FESCA_handinhand

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.

What is systemic sclerosis?

We are proud to announce that with support from 2 patients – one in Italy and one in Denmark – Boehringer-Ingelheim has developed an illustrated infographic (like a cartoon) on systemic sclerosis.

Infographic of Systemic Sclerosis, by Boehringer-Ingelheim

ssc_infographic_BI

 

Scleroderma Support Group Survey

Do you have scleroderma? Are you interested in helping advance research on
scleroderma support groups? If so, please lend a hand by completing this short 10-15
minute survey!

Our team, which is comprised of international researchers; people with scleroderma; and
leaders from the Federation of European Scleroderma Associations, the Scleroderma
Foundation of the United States, and the Scleroderma Society of Canada are working
together to learn more about the experiences of scleroderma support group facilitators,
scleroderma support group members, and people who choose not to attend scleroderma
support groups.

Your anonymous answers to the survey questions will provide a greater understanding of
the important training and support needs of group leaders, as well as the reasons why
people with scleroderma either attend or do not attend support groups. The results from
this survey will be used to increase the accessibility of scleroderma support groups and to
structure these groups in a way that increases their ability to effectively meet the needs of
members.

If you have a few minutes to spare and are able to help with this exciting research project,
please click on the following link, which will take you directly to the survey:

https://survey.co1.qualtrics.com/SE/?SID=SV_cAdjVJSxLa0PHdH

If you have any additional questions or concerns about the survey, please contact any
member of our research team listed below:

MS. STEPHANIE GUMUCHIAN
MSc. Psychiatry Student, McGill University
Telephone: (514) 340-8222 ext. 6813; Email: sgumuchian@gmail.com

OR

MS. VANESSA DELISLE
PhD. Counselling Psychology Student, McGill University
Telephone: (514) 340-8222 ext. 6812; Email: vanessa.delisle@mail.mcgill.ca

OR

MS. MIA PEPIN
BSc. Psychology Student, Université de Montréal
Telephone: (514) 340-8222 ext. 8578; Email: mia.r.pepin@gmail.com

FASST – A trial targeting fibrosis in the skin

The FASST (For A Systemic Sclerosis Trial) 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.

IVA337 is a new drug with anti-fibrotic properties meaning that it might be able to act on several components of the fibrotic process and on several organs.

The primary objective of this study is to evaluate in patients suffering from diffuse cutaneous SSc (DcSSc) the effect of 800mg and 1200mg IVA337 daily on the skin compared to placebo. The modified Rodnan Skin Score (mRSS) will be used to determine the changes in skin.

In the video below developed by Inventiva Pharma, Prof. Yannick Allanore, explains mRSS. For other languages,  please visit the trial’s website.

 

The trial is randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis.

Go to www.fassttrial.com for further information.

Read latest newsletter. [PDF]

Videos from 4th Systemic Sclerosis World Congress

logo

More than 300 patients participated the patient’s congress at 4th Systemic Sclerosis World Congress in Lisbon, February 18-20, 2016.

We had joint sessions and experts were ready to answer questions such as:

  • What are the options in treating SSc?
  • Is the heart involved?
  • Why is breathing so difficult?
  • What can I do to help my digestion problems?
  • What can be done about the pain in my feet?
  • Should I consider a transplant?
  • Can I try to get pregnant safely?
  • What new therapies are available now?
  • What are researchers and FESCA doing for us?
  • How can I cope with my fatigue?
  • Can I get help as a man with SSc?
  • How can my family and I deal with depression?
  • How can children with SSc learn to cope?

The patient congress also included interactive exercise and breathing sessions, plus a round-table networking meeting for leaders of patient groups the afternoon before the congress, and plenty of networking opportunities during it.

Many patients were present for the first time and some of the reactions were:

“The meeting with other scleroderma patients from other countries of the world was very impressive, and you found new friends. Even though I have lived with this disease for more than 30 years, I learned many new things from other patients”

“It was SO amazing. Kindness and care was everywhere, and it was a pleasure to hear the lectures from such enthusiastic doctors and brave patients telling their own experiences living with this disease. I learned so much about scleroderma and how to cope with the disease without loosing ME!”

Recordings from the 4th Systemic Sclerosis World Congress

The sessions in the auditorium were recorded, and we are happy to share those with you.  We are in process of converting the videos with the translated audio – French, Spanish and Portuguese. When they are ready, you will find them here, too.

Friday 19 Feb

9.00-9.10 FESCA welcome. A. Kennedy (Ireland)

9.10 – 9.30 Opening Lecture: What do we know about scleroderma now? / Prof C. Denton (UK)

9.30 – 10.30 What will help my digestive problems?

  • Understanding the GI tract  Prof. J. Clarke (USA)
  • Nutrition in SSc  A. Cardoso (Portugal)
  • Learning to Cope with Gut Problems  A. Vegh (Hungary)
  • My Journey I. Galetti (Italy)

Chairs: A. Kennedy (IE), C. Denton (UK)

 

10.30 -11.00    Coffee Break

11.00-12.00   What will Help me Breathe Easily? Is my Heart Involved?

  • Understanding lung problems  Prof. O. Distler (CH)
  • PAH and the Heart  Dr. A. Cordeiro (Portugal), Dr. M.J. Loureiro (Portugal)
  • Struggles with Breathing  A. Roennow (Denmark)

Chairs: A. Portales (SP), Dr. A. Herrick (UK)

 

12.00-13.00      Can I improve my sexual relations, or get pregnant safely?

  • Improving Sexuality  Prof. A. Tincani (IT)
  • Is it Safe to get Pregnant?  Prof. V. Steen (USA) 
  • My New Baby  C. Leite (Portugal)
  • Developing Sexual Confidence  G. Verzi (IT)
  • Enjoying your Relationship  R. Kanters (NL)

Chairs: A. Kennedy (IE), Dr. G. Riemekasten (D)

13.00-14.00      Lunch

14.00-14.40    What will Cure the Pain of Digital Ulcers & Calcinosis? 

  • Our Recommendations for Treatment of Ulcers   Prof. M. Matucci-Cerinic (I)
  • How we Care for Ulcers in a Portuguese Clinic  Prof. J. Delgado Alves (Portugal)
  • Pain: The Greatest Struggle for Many Patients  Y. Courcoux (F)

Chairs: D. Charalambous (Cy), E. Mateus (Portugal)

14.40-15.15      How do I Cope with my Facial Changes?

  • Changing Faces and Self-Esteem  Prof. A. Tyndall (CH)
  • Readjusting my Life  M. Sauvé (CAN)
  • My Story   S. Sandulescu (Romania)

Chairs: B. Garay-Toth (Hungary), Prof. P. Carriera (SP)

 

15.15-16.30         How Can I Manage SSc Myself?

  • Five Ways to Manage your Symptoms  Dr. L. Kwakkenbos (NL)
  • Do Support Groups Help? V. Delisle (CAN)
  • Painful Symptoms that Cannot be Measured  Dr. Jason Lee (CAN)
  • Mind & Body Strength Dr. L.A. Saketkoo (USA)

Chairs: N. Paciotti (CH), A. Kennedy (IE)

 

Saturday 20 Feb

9.00-10.00        “Meet the Professor”: Answers to your questions in your own language

in English, Room 3A    Prof. Maureen Mayes (USA) & Prof. Patricia Carriera (SP)  (translation into Portuguese, French, Spanish), Chair: A. Portales (SP)

in German, Room 3C   Prof. U. Müller-Ladner (D), Chair: G. Niehaus (D)

in Italian, Room 3B     Prof. M. Matucci-Cerinic (I), Chair: G. Tassini (I)

10.00-11.00      What is Research doing for Me? What New Therapies can I try?

  • The Hope of Systemic Drugs  Prof. C. Denton (UK)
  • Considering Stem-Cell Transplants  Prof. J. Van Laar (NL)
  • My Lung Transplant  A. Martin (CH)
  • My Stem-Cell Transplant  R. Kanters (NL)

Chairs: J. Welling (NL), Prof. A. Tyndall (CH)

11.00-11.30      coffee break

11.30-12.00         After 10 years with SSc, What Can I Expect? 

  • Predicting the Future with SSc   Dr. Jason Lee (CAN)
  • A Long Life With SSc  K. Fligelstone (UK)

Chair: A. Roennow (Denmark)

12.00-13.00      Coping: How can my family and I manage SSc better?

  • Dealing with Chronic Fatigue  Dr. J. Poole (USA)
  • Breathing Exercises Dr. J.Poole (USA)
  • How to share SSc with a loved one  H. and I. Lever (Sweden)
  • Finding your way as a single mother: M. Gaafar (CH)
  • A Meditation for stress relief: Dr. L. A. Saketkoo (USA)

Chair: A. Kennedy (IE)

 

13.00  CLOSURE OF CONGRESS

 

 

The Desscipher project is closing to it’s end

Since the start the latest recruitment (1st April 2013 till 21st July 2015) of the five observational trials is: nearly 2089 patients with systemic sclerosis have been screened and 1862 patients have been enrolled into the trials for primary analysis.

Thus, with the help of FESCA and other contributing centers the DeSScipher project had become the largest prospective observational research project ever on systemic sclerosis!

The main contributing EUSTAR centres are from Italy, Switzerland, UK. Hungary, France, Spain, Croatia, Germany, Russia, Romania, Turkey, Egypt.

Please find the detailed patient recruitment numbers for all OT (observational trial) and the center below.

Number of patients enrolled into the observational arms of all OTs

desscipher_patientsenrolled
desscipher_recruitmentprocess

What is the DeSScipher project?

DeSScipher is the 1st international EC-funded research project, and currently also the largest project, on the rare disease systemic sclerosis (SSc). DeSScipher aims to decipher the optimal management of systemic sclerosis. The goals of this project are to improve the treatment strategies for people with systemic sclerosis, and thus to help affected patients to get more quality of life. The projects comprises five observational, non-interventional studies which started in April 2013 and have been designed to cover different evolution phases of the disease from early, functionally relevant manifestations such as digital ulcers and hand arthritis to later, more severe organ manifestations such as interstitial lung disease, pulmonary hypertension and severe heart disease. Moreover, DeSScipher aims to improve the education of people with systemic sclerosis and physicians, and ultimately to achieve a better care for patients by the development of accepted evidence-based clinical guidelines.

The activities of FESCA within the DeSScipher project

FESCA aisbl. is a full partner of the DeSScipher project and deeply involved since the very beginning of the five observational trials. The main task of FESCA is to actively disseminate the research project in Europe and in its member countries. To introduce the project the main launch activities were in 2013 but some member countries joined to communicate the project in 2014. FESCA supported the project through its World Scleroderma Day in 2013, 2014 and 2015. In this year DeSScipher was highlighted in the EU Pariament Event in Brusseles where WSD was celebrated.

Next steps

The project will come to  the end in 30th November 2015.

The closer event of this huge project is the Dissemination Meeting of Project DeSScipher in Bad Nauheim in Germany from 27-29th November. All the participants of the project, the representatives and physicians of the involved clinics, representatives of FESCA are invited to the event. In this meeting a detailed report about the results of the separate OTs (Observational Trials) will be introduced.

After the results are ready to distribute FESCA task will be to help disseminate the outcome among our member countries in 2016.

Thank you for the contribution of our member associations to help achieving this great number of participation to make this project successful.

 

Beata Garay Toth
Vice-president, FESCA
DeSScipher representative