Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, other

- Prednisone
- Cyclosporine (ATC code: L04AD01)
- Beta interferone -1a
- Beta interferone-1b
- Inmunoglobulines
- Brimionidine

Study drug International non-proprietary name (INN) or common name

ABATACEPT
ADALIMUMAB
AZATHIOPRINE
BASILIXIMAB
CHLOROQUINE
CYCLOPHOSPHAMIDE
ECULIZUMAB
ETANERCEPT
HYDROXYCHLOROQUINE
INFLIXIMAB
METHOTREXATE
METHYLPREDNISOLONE
MYCOPHENOLATE MOFETIL
RITUXIMAB
TACROLIMUS

Anatomical Therapeutic Chemical (ATC) code

(A07EA03) prednisone
prednisone
(H02AB04) methylprednisolone
methylprednisolone
(J06BA) Immunoglobulins, normal human
Immunoglobulins, normal human
(L01AA01) cyclophosphamide
cyclophosphamide
(L01FA01) rituximab
rituximab
(L03AB07) interferon beta-1a
interferon beta-1a
(L03AB08) interferon beta-1b
interferon beta-1b
(L04AA06) mycophenolic acid
mycophenolic acid
(L04AA24) abatacept
abatacept
(L04AA25) eculizumab
eculizumab
(L04AB01) etanercept
etanercept
(L04AB02) infliximab
infliximab
(L04AB04) adalimumab
adalimumab
(L04AC02) basiliximab
basiliximab
(L04AD02) tacrolimus
tacrolimus
(L04AX01) azathioprine
azathioprine
(L04AX03) methotrexate
methotrexate
(P01BA01) chloroquine
chloroquine
(P01BA02) hydroxychloroquine
hydroxychloroquine
(S01EA05) brimonidine
brimonidine

Medical condition to be studied

Dermatomyositis
Polymyositis
Juvenile polymyositis

Additional medical condition(s)

Juvenile dermatomyositis, Neonatal dermatomyositis
Population studied

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

19500000
Study design details

Main study objective

The overall objective of this study is to describe and characterise dermatomyositis (DM), polymyositis (PM) and their juvenile forms (JDM and JPM), in terms of prevalence, natural history of the disease, disease severity, and treatment.

Data analysis plan

Point prevalence of each outcome of interest (DM, PM, JDM, JPM), with every individual deemed to have the diagnosis from first occurrence until end of follow-up calculated on an annual basis as of the 1st January for each year, estimated overall and stratified by age and sex. Age and sex at time of DM, PM, JDM, JPM diagnosis (index date) will be described for each of the generated study cohorts (Objective 2). Large-scale patient-level characterisation will be conducted for objectives 3 to 5. Occurrence of co-morbidities, measurements, clinical manifestations, and severity markers will be assessed for anytime –and up to 365 days before index date, for 364 to 91, for 90 to 31, and for 30 to 1 day before index date, and at index date. We will also report them for 1 to 90, 91 to 180, 181 to 365 days, 366 to 1095, 1096 to 1825 days, and 1826 days to any time post index date.
Documents
Study results
English (5.48 MB - PDF)View document