Study title: Double-blind, eight-month extension study to collect durability of efficacy data and additional safety data in patients with juvenile rheumatoid arthritis completing the double-blind comparison study HWA486/3503 of leflunomide versus methotrexate
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Immune System Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: LEFLUNOMIDE | |||||
ATC code: | |||||
Document link: Leflunomide-Study 3.pdf | |||||
Document date: 2011-09-23 | |||||
Study number: HWA486/3504 | |||||
EudraCT number: | |||||
Scope of study: CLINICAL | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
- | - | - | - | - |