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Клинические исследования в Украине

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Описание
Краткое названиеA Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)
Полное названиеA Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)
СпонсорCentocor, Inc.
Industry
ИсточникCentocor, Inc.
Под контролемCanada: Ethics Review Committee
Canada: Health Canada
Краткое описаниеThis is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients
with moderate to severe psoriasis.
СостояниеИдет набор
Дата началаMay 2010
ФазаPhase 3
Подробное описаниеUstekinumab is a drug that is being tested to see if it may be useful in treating
adolescents with moderate to severe plaque-type psoriasis. This study will compare the
effects (both good and bad) of ustekinumab to those of placebo. Placebo looks like the drug
being studied but has no active ingredients. Ustekinumab (also known as Stelara) has been
approved by the Food and Drug Administration, Health Canada, European and other global
regulatory authorities for the treatment of patients with moderate to severe plaque-type
psoriasis. Ustekinumab is being studied in several other illnesses. About 150 adolescents
will take part in the study. Each patient who is allowed to join the study is put into a
group by chance (randomly). There are 4 treatment groups in this study: GROUP 1:
Ustekinumab low dose at weeks, 0, 4, 16, 28 & 40. Placebo injections at week 12. GROUP 2:
Ustekinumab high dose at weeks 0, 4, 16, 28 & 40. Placebo injections at week 12. GROUP 3a :
Placebo at Weeks 0 and 4, Ustekinumab low dose at Weeks 12 and 16, 28 & 40. GROUP 3b:
Placebo at Weeks 0 and 4, Ustekinumab high dose at Weeks 12 and 16, 28 & 40. For dose
description, please refer to Treatment Arm Section. Each patient will either receive
ustekinumab or placebo, at the start of the study. By week 12 everyone will be receiving
Ustekinumab. The dose of medication the patient will receive is based on his/her assigned
group and the patient's weight. There are 2 dose groups - low dose and high dose. So that no
one knows which dose any patient is receiving at one time - 2 injections will be given to
each patient at each injection visit. While the study is ongoing, neither the patient nor
the study doctor (or his/her staff) will know which treatment group the patient is in.
Patients will be in the study approximately 60 weeks. Clinical safety will be assessed by
the incidence and severity of adverse events, clinical laboratory tests, vital signs and
physical examinations during the study period. There are 4 treatment groups in this study.
Group 1 will receive Ustekinumab low dose at weeks, 0, 4, 16, 28 & 40. Placebo injections
at week 12. Group 2: Ustekinumab high dose at weeks 0, 4, 16, 28 & 40. Placebo injections
at week 12. Group 3a: Placebo at Weeks 0 and 4, Ustekinumab low dose at Weeks 12 and 16, 28
& 40 and GROUP 3b: Placebo at Weeks 0 and 4, Ustekinumab high dose at Weeks 12 and 16, 28 &
40.
Вид исследованияAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

- Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA)
for at least 6 months

- Are candidates for phototherapy or systemic treatment of psoriasis

- Have screening laboratory test results within the study parameters

Exclusion Criteria:

- Currently have nonplaque forms of psoriasis

- Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or
interleukin-23 (IL-23), including but not limited to ustekinumab and briakinumab

- Received conventional systemic therapies or phototherapy within the last 4 weeks

- Received biologic therapies within the last 3 months
ПолBoth
Минимальный возраст12 Years
Максимальный возраст18 Years
УсловиеPsoriasis
Применяемое лечение
Biologicalustekinumab/placebo
Biologicalustekinumab/placebo
Biologicalustekinumab/placebo
Контакты и расположение
Khmelnitskiy
Kyiv
Simferopol
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