EUCTR2014-002320-27-HR进行中（未招募）1 期
A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients.
Celgene International II Sàrl (CIS II)0 个研究点目标入组 1,346 人开始时间: 2015年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,346
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
- •1. MS, as diagnosed by the revised 2010 McDonald criteria
- •2. Exhibiting a relapsing clinical course consistent with RMS and history of brain MRI lesions consistent with MS
- •3. Ages 18-55 years, inclusive
- •4. EDSS score between 0 and 5.0 at baseline
- •5. Meet one of the following disease activity criteria:
- •o At least 1 documented relapse within the last 12 months prior to screening
- •o At least 1 documented relapse occurred within the last 24 months prior to screening and documented evidence of at least 1 GdE lesion on brain MRI within the last 12 months prior to randomization
- •6. No history of relapse with onset from 30 days prior to screening until randomization; during this period, patients must have been clinically stable, without systemic corticosteroid treatment or adrenocorticotrophic hormone (ACTH)
- •7. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
- •8. Patients of reproduction potential (males and females) must practice an acceptable method of birth control (acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, vasectomy, or double-barrier method [condom or diaphragm with spermicide]) during study participation and for 30 days after their last dose of treatment of study medication or true sexual abstinence (periodic abstinence [calendar, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
- •9. Patients must have documentation of positive Varicella zoster virus (VZV) IgG antibody status or complete VZV vaccination at least 30 days prior to randomization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1346
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Primary progressive MS at screening
- •2. Disease duration of more than 15 years in patients with an EDSS =2.0
- •3. Contraindications to MRI or Gadolinium contrast, such as known allergy to Gadolinium contrast dyes, renal insufficiency, claustrophobia, body size incompatible with the scanner, pacemaker, cochlear implants, intracranial vascular clips
- •4. Incompatibility with beta IFN use (e.g. intolerable side effects)
- •5. Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (ß-hCG) measured during screening
- •6. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the patient at risk by participating in the study in the opinion of treating investigator
- •7. Specific cardiac conditions are excluded, including history or presence of:
- •i. Recent (within the last 6 months) occurrence of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, Class III/IV heart failure, sick sinus syndrome, or severe untreated sleep apnea
- •ii. Prolonged QTcF interval (QTcF >450 msec males, >470 msec females), or at additional risk for QT prolongation (e.g., hypokalemia, hypomagnesemia, congenital long-QT syndrome, concurrent therapy with QT-prolonging drugs)
- •iii. Patients with other pre-existing stable cardiac conditions who have not been cleared for the study by an appropriate cardiac evaluation by a cardiologist
- •iv. Other clinically significant conduction abnormalities or any other significant cardiac condition that could jeopardize a patient’s health or put them at significant safety risk during the course of the study in the opinion of treating investigator
- •8. Resting heart rate less than 55 bpm at Screening
- •9. Diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with hemoglobin A1c >9% , or diabetic patients with significant co-morbid conditions such as retinopathy or nephropathy
- •10. History of uveitis
- •11. Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis [TB] or atypical mycobacterial disease [but excluding fungal infection of nail beds, minor upper respiratory tract infections [URTI] and minor skin infections]) or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of screening or oral antibiotics within 14 days prior to screening
- •12. History or known presence of recurrent or chronic infection; recurring urinary tract infections could be allowed
- •13. History of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved)
- •14. Suicide attempts in the past or current signs of major depression
- •15. History of alcohol or drug abuse within 1 year prior to randomization
- •16. History of or currently active primary or secondary immunodeficiency
- •17. Prior use of any investigational agent within 6 months prior to enrollment
- •18. Receipt of a live vaccine within 4 weeks prior to randomization
- •19. Non-lymphocyte-depleting disease-modifying MS agents must be discontinued from signing of informed consent
- •20. Previous treatment with lymphocyte-depleting therapies
- •21. Treatment with other immunosuppressant agents such as azathioprine, cyclosporine, methotrexa
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