Disease Registry for Patients with Digital Ulcers associated with Systemic Sclerosis (DUO Registry)

Study identification

• EU PAS number:
  EUPAS4619
• Study ID:
  28356
• Official title and acronym:
  Disease Registry for Patients with Digital Ulcers associated with Systemic Sclerosis (DUO Registry)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Czechia

  Denmark

  Finland

  France

  Germany

  Greece

  Ireland

  Italy

  Netherlands

  Norway

  Portugal

  Slovakia

  Slovenia

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  The registry is a multi-center, prospective, observational, non-interventional program and was designed to document adherence to the Summary of Product Characteristics (SmPC) requirements for liver function tests, pregnancy testing and the use of adequate contraception in DU/ SSC patients exposed to Tracleer, to collect Safety relevant information from patients treated with Tracleer and to obtain data on DU disease history, baseline characteristics (collected at the time of enrolment into the registry), and disease course irrespective of treatment regimen, in patients with DU/ SSC.Inclusion criteria: At time of enrolment the patient must present with Systemic sclerosis and ongoing digital ulcer disease.Exclusion criteria: Patients refused to sign the patient informed consent.
• Study status:
  Finalised

Research institutions and networks

Institutions

Actelion Pharmaceuticals

Multiple centres: 428 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 10/03/2008

Study start date

Actual: 14/04/2008

Date of final study report

Actual: 02/03/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Actelion

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)