Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Drug utilisation
Effectiveness study (incl. comparative)
Safety study (incl. comparative)

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Scleroderma associated digital ulcer
Population studied

Short description of the study population

Patient with Systemic sclerosis and ongoing digital ulcer disease at time of enrolment.

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

6108
Study design details

Main study objective

For Tracleer treated patients only: to document adherence to the Summary of Product Characteristics (SmPC) requirements (liver enzymes monitoring, pregnancy testing and contraception methods) and to describe the occurrence of specific safety (e.g. pregnancy and discontinuation reasons).For ALL patients: to describe DU disease history, baseline status and disease course.

Outcomes

Proportion compliance to SmPC, occurrence of new DUs, and complications and interventions associated with DUs.

Data analysis plan

Safety of Tracleer: cumulative event rates, Adherence to Tracleer SmPC requirements: Proportion of patients with contraception, pregnancy testing and LFT monitoring, DU disease history, patient entry characteristics and disease course: descriptive statistics by treatment group, time to event estimate.