EUCTR2011-005677-23-SK进行中（未招募）1 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 ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase - PARADIGMS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Core phase:
- •1. Written informed consent/assent must be obtained before any assessment is performed.
- •2. Male and female patients aged 10-17 years old*, inclusive (i.e., have not yet had their 18th birthday) at randomization.
- •3. A diagnosis of MS as defined by the revised consensus definition for pediatric MS (Krupp et al 2013, Polman et al 2011).
- •4. Central review of the diagnosis of pediatric MS will be required for all patients prior to randomization.
- •5. 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).
- •6. Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive.
- •*Exception: If, in a specific country, use of interferon-ß-1a IM in children below a certain age is included in the contraindications section of Avonex (interferon-ß-1a IM) local product information, inclusion of such patients is not permitted in that country. E.g. the Russian Avonex product information lists use in children below the age of 12 years as a contraindication.
- •Fingolimod Extension Phase:
- •Criterion applies to all patients participating in the Core Phase and then entering the Extension Phase.
- •1. Patients that originally met Core Phase Inclusion criteria and completed the Core phase on or off of study drug.
- •Criterion apply to patients newly recruited to participate in the Extension Phase.The 'younger cohort' is defined as the population of pediatric patients fulfilling any single one or a combination of the following criteria: being =12 years of age, or weighing =40 kg, or being
- •pre-pubertal (i.e. pubertal status of Tanner stage <2).
- •All newly recruited patients' that enroll directly into the Extension Phase must fulfill the local country health authority product label approved for pediatric age group for inclusion criteria.
- •Central review (including initial MRI report) of the diagnosis of pediatric MS (Thompson et al 2018) will be required for all newly recruited patients.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 240
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Core & Extension Phase:
- •1. Patients with progressive MS
- •2. Patients with an active, chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. Sjögren's disease, systemic lupus erythematosus) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency) or tested positive for HIV
- •3. Patients with widespread and symmetric white matter alterations in the Screening MRI suggestive of other demyelinating disorders (e.g. metabolic disorders, mitochondrial disorders)
- •4. 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).
- •5. Patients treated with:o Systemic corticosteroids or adrenocorticotropic hormone (ACTH) in the 30 days prior to Screening MRI scan
- •o High dose intravenous immunoglobulin within 2 months prior to randomization/first dose in the extension
- •o Natalizumab within 3 months or teriflunomide within 3 ½ months prior to randomization/first dose in the extension
- •o Immunosuppressive/immunomodulatory medications such as azathioprine, methotrexate, laquinimod, ofatumumab,ocrelizumab within 6 months prior to randomization/first dose in the extension o Alemtuzumab, cladribine, cyclophosphamide, mitoxantrone or rituximab at any time o Fingolimod at any time o The following antiarrhythmic drugs at Screening: Class Ia (e.g. quinidine, disopyramide) or Class III (e.g. amiodarone, sotalol) antiarrhythmics o Concurrently treated with heart-rate-lowering drugs at Screening e.g.: Beta blockers, heart-rate lowering calcium channel blockers (e.g. verapamil, diltiazem or ivabradine), digoxin, anticholinesteratic agents, pilocarpine Advice from a cardiologist should be sought regarding the switch to nonheartrate lowering medicinal products
- •6. Patients diagnosed with macular edema during the screening period. 7. Patients with active systemic bacterial, viral or fungal infections, including tuberculosis 8. Patients without acceptable evidence of immunity to varicella-zoster virus, mumps, measles, rubella, diphtheria, tetanus and pertussis at Randomization/ first dose in the extension (See Appendix 3 Guidance on vaccinations for guidance on acceptable evidence of immunity and requirements for serologic testing)
- •9. Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within one month prior to randomization/ first dose in the extension 10. Patients with a history or presence of malignancy
- •11. Patients with any medically unstable condition, as assessed by the investigator
- •12. Patients with any severe cardiac disease or significant findings on the screening ECG, such as:
- •o History of symptomatic bradycardia or recurrent syncope o Known ischaemic heart disease
- •o History of congenital heart disease (except conditions such as small patent ductus arteriosus, atrial septal defect, ventricular septal defect, or an ECG or rhythm abnormality, which have been assessed by a pediatric cardiologist and considered to be clinically insignificant) o Cerebrovascular disease o History of myocardial infarction o Congestive heart failure o History of cardiac arrest o Uncontrolled hypertension despite prescribed medications o Resting (sitting) heart r
研究者
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