NL-OMON53151招募中3 期
A two-year, double-blind, randomized, multicenter, active controlled, study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon β-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase - CFTY720D2311 fingolimod in pediatric MS patients.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 17（—）
入选标准
- •Core phase:
- •1. Male and female patients aged 10-17 years old, inclusive (i.e., have not yet
- •had their 18th birthday) at randomization.
- •2. A diagnosis of MS as defined by the revised consensus definition for
- •pediatric MS (Krupp et al 2013, Polman et al 2011).
- •3. Central review of the diagnosis of pediatric MS will be required for all
- •patients prior to randomization.
- •4. At least one MS relapse/attack during the previous year or two MS relapses
- •in the previous two years prior to screening, or evidence of one or more Gd
- •enhancing lesions on MRI within 6 months prior to randomization (including
- •screening MRI).
- •5. Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive.,
- •Extension Phase:
- •Criterion applies to all patients entering the Extension Phase;
- •- Patients that originally met Core Phase Inclusion criteria and completed the
- •Core phase on or off of study drug.
- •Criterion applies to patient newly recruited to participate in the Extension
- •Younger cohort is defined as the population of pediatric patients fulfilling
- •any single one or a combination of the following criteria: being 12 or younger
- •of age, weighing 40 kg or less, or being pre-pubertal (Tanner stage less than 2)
- •1. All newly recruited patients* that enroll directly into the Extension Phase
- •must fulfill
- •the local country health authority product label approved for pediatric age
- •inclusion criteria. Countries that do not have the 0.25mg dose formulation of
- •approved according to local label, may only enroll patients within the younger
- •have a body weight above 40 kg and be prescribed the 0.5mg dose level according
- •local label.
- •2. Central review (including initial MRI report) of the diagnosis of pediatric
- •(Thompson et al 2018) will be required for all newly recruited patients.
排除标准
- •Core and extension phase:
- •1. Patients with progressive MS.
- •2. Patients with widespread and symmetric white matter alterations in the
- •Screening MRI suggestive of other demyelinating disorders (e.g. metabolic
- •disorders, mitochondrial disorders).
- •3. Patients meeting the definition of ADEM (Krupp et al 2013); patients meeting
- •critieria for neuromyelitis optica (Wingerchuk et al 2006) or tested positive
- •for aquaporin 4 (AQP4) at Screening. Patients who have tested positive for
- •anti-MOG (applicable for patients enrolling in the new younger cohort in
- •extension phase)
- •4. Patients with active systemic bacterial, viral or fungal infections,
- •including tuberculosis.
- •5. Patients without acceptable evidence of immunity to varicella-zoster virus,
- •mumps, measles, rubella, diphteria, tetanus and pertussis at randomization/
- •first dose in the extension phase.
- •6. Patients with any severe cardiac disease or significant findings on the
- •screening ECG.
- •7. Positive results of screening period testing for serological markers for
- •hepatitis A, B, C, and E indicating acute or chronic infection.,
- •Extension phase:
- •Criteria apply to patients who completed the Core Phase, but prematurely
- •discontinued study drug;
- •- Premature discontinuation of the study drug during the Core Phase due to an
- •adverse event, serious adverse event, laboratory abnormality or conditions
- •leading to permanent study drug discontinuation due to safety reasons as
- •described in the protocol.
- •- Patients with known new events or concomitant medications that would exclude
- •them from the Core Phase exclusion criteria.
研究者
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