Focus On Capillaroscopic Ulcer index in Systemic sclerosis: a national, multi-centre, prospective, observational, non-interventional pilot study

Actelion Pharma Schweiz AG (Switzerland)0 个研究点目标入组 61 人开始时间: 2011年3月18日最近更新: 2019年9月9日

适应症

试验速览

•1. Definitive diagnosis of systemic sclerosis (SSc) by the American College of Rheumatology (ACR) criteria
•2. History of documented digital ischaemic ulcers secondary to SSc within the past year prior to enrolment or with at least one active digital ischaemic ulcer (DU) at enrolment
•3. Signed patient informed consent form

•1. Patient refused to sign the patient informed consent
•2. DUs due to a condition other than SSc
•3. DU associated with calcinosis
•4. Treatment with parenteral prostanoids or Tracleer®) within the past 3 months before enrolment
•5. Treatment with phosphodiesterase-5-inhibitors (PDE-5-I), except for intermittent treatment of male erectile dysfunction
•6. Treatment with other Endothelin-receptor-antagonists (ERA)
•7. Patients receiving any other experimental treatment
•8. Patients receiving systemic antibiotics for infected ulcers
•9. Patients with active renal crisis or advanced cardiopulmonary disease or who are otherwise clinically unstable

发起方

Actelion Pharma Schweiz AG (Switzerland)