Incidence rates of morphoea, systemic sclerosis and scleroderma

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Morphoea

  Systemic scleroderma

  Scleroderma

Population studied

• Short description of the study population:
  The study focused on general population in the UK and patients visiting general practices in Germany, France, Spain, Italy and Romania identified from the IMRD databases to determine the incidence rates of morphoea, systemic sclerosis and scleroderma.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with morphoea, systemic sclerosis and scleroderma
• Estimated number of subjects:
  1600

Study design details

• Main study objective:
  The objectives of the study were to describe: Incidence rates of (a) morphoea (including localised and linear scleroderma), (b) systemic sclerosis, and (c) scleroderma (including both systemic and localised/linear) in the general population and in patients with diagnosis of Hodgkin lymphoma and malignant neoplasms.
• Outcomes:
  Morphoea (localised and linear scleroderma), systemic sclerosis and scleroderma (including both systemic and localised/linear), Incidence rates in the general population were stratified by sex, age group, and year of recorded diagnosis. Incidence rates in patients with cancer diagnosis were stratified by sex and age
• Data analysis plan:
  This was a cohort study describing population- and patient-level incidence rates of morphoea (including localised and linear scleroderma), systemic sclerosis and scleroderma (including both systemic and localised/linear in a number of European databases