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.
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.
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 firstname.lastname@example.org
Angela Tincani, Rheumatology, Università degli Studi di Brescia, Spedali Civili, Piazzale Spedali Civili 1, 25123, Brescia, Italy email@example.com
Antonio Brucato, Internal Medicine, Ospedale Papa Giovanni XXIII (previously named Ospedali Riuniti) Piazza OMS 1, 24127 Bergamo, Italy firstname.lastname@example.org
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.
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.
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
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
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
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:
The FASST (For ASystemic 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.
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)
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)
12.00-13.00Coping: 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)