Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

ENJAYMO

Medical condition to be studied

Cold type haemolytic anaemia

Additional medical condition(s)

Cold agglutinin syndrome
Population studied

Age groups

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

Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women

Estimated number of subjects

400
Study design details

Main study objective

To develop an international database of patients with CAD or CAS (previously known as secondary CAD) to prospectively collect longitudinal data and better understand patient and clinical characteristics, disease progression, complications, treatment impact, and patient-reported outcomes. To assess the safety and the effectiveness of sutimlimab in patients with CAD in a real-world setting.

Data analysis plan

Continuous variables will be characterized with non-missing observations, mean and standard deviation, median, 1st and 3rd quartiles, minimum and maximum, and number of missing data. Categorical variables will be characterized by the frequency and percent distribution in each category and the number of missing data. 95% confidence intervals of means and percentages will be provided, if relevant. Time-to-event outcomes will be assessed using Kaplan-Meier analysis. Repeated measures analyses may be used for outcomes collected at more than one time point, such as HRQoL or laboratory values.