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Клинические исследования в Украине

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Описание
Краткое названиеA Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease
Полное названиеA Phase IIIb, Open-label, follow-on Trial to C87085 Designed to Assess the Long-term Safety of Certolizumab Pegol, in Subjects With Moderately to Severely Active Crohn's Disease Who Have Participated in Study C87085
СпонсорUCB, Inc.
Industry
ИсточникUCB, Inc.
Под контролемUnited States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: Ministry of Health
Canada: Health Canada
Chile: Instituto de Salud Publica de Chile
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
France: Afssaps - French Health Products Safety Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: National Institute of Health
Latvia: State Agency of Medicines
New Zealand: Health Research Council
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Ukraine: Ministry of Health
No
Краткое описаниеThe primary objective of the study is to assess the safety of long term therapy with
certolizumab pegol in those subjects participating in study C87085.
СостояниеАктивный, набор окончен
Дата началаMay 2008
ФазаPhase 3
Вид исследованияAllocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

- Subjects participated in study C87085

Exclusion Criteria:

- General exclusion criteria as common for open-label extension studies
ПолBoth
Минимальный возраст18 Years
Максимальный возраст75 Years
УсловиеCrohn Disease
Применяемое лечение
BiologicalCertolizumab Pegol
Контакты и расположение
Dniepropetrovsk
Donetsk
Kiev
Lviv
Simferopol
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