Are you living with diffuse scleroderma?
Would you like to be involved in a clinical study testing a new investigational drug for use in Diffuse Scleroderma?
If so, you may be eligible to take part in the DECODE Scleroderma Study.
Diffuse Scleroderma is a chronic and life limiting condition for which there is currently no cure. Treatment is based on the management of symptoms and the prevention of further complications
There is an urgent unmet need to better support people living with diffuse scleroderma through more effective treatments. The DECODE Scleroderma Study is testing an investigational study drug to see if it is effective in reducing the symptoms and severity of Diffuse Scleroderma.
If you are living with diffuse scleroderma and meet the eligibility criteria listed below you could help by taking part in this new clinical study.
Can I take part?
You may be eligible to participate if:
• You are over 18 years of age
• You have been diagnosed with Diffuse Scleroderma
• It has been 5 years or less since the appearance of Diffuse Scleroderma symptoms other than Raynaud’s Phenomenon
About the DECODE Scleroderma Study
The DECODE Scleroderma Study is trying to determine whether an investigational study drug reduces symptoms and severity of diffuse scleroderma.
The investigational study drug is being compared with a placebo – a substance that looks similar to the study drug but contains no active medication.
Participants are chosen randomly by computer as to whether they receive the investigational study drug or the placebo.
What is Involved and how will it affect my current treatments?
You would be involved for approximately 60 weeks which includes screening, treatment and follow-up.
The study drug will be administered orally once daily, in the morning, with or without food. You would also continue with your current treatments for Diffuse Scleroderma.
Participation includes attending up to nine study visits.
Throughout the study, staff will monitor your health. The site will also perform physical examinations and collect blood and urine samples for laboratory testing. Over the course of the study, you will be asked to complete study-related questionnaires.
What happens when I sign up?
The first step will be to meet a member of the study team at your local research centre to review an Informed Consent Form. This form fully explains the purpose of the study, possible risks and benefits, and what is expected of you.
No procedures will begin until all your questions are answered, and you have signed this form confirming your understanding of its contents and your agreement to take part
in the study.
You can choose to leave the study at any time and for any reason.
Who will be joining the study?
The DECODE Scleroderma Study will include about 50 research sites in eight countries – UK, Belgium, Germany, Spain, Italy, Poland US, and Canada. The aim is to have approximately 72 adults with diffuse scleroderma taking part in the study across those countries.
All study assessments, procedures and the study drug will be provided at no cost to you / free of charge.
Register to learn more about this study, your eligibility and what’s involved
How are FESCA involved?
We are helping to promote the study as we believe it is of interest, and could be of benefit, to the scleroderma community.
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