EUCTR2006-001161-42-HU进行中（未招募）不适用
Multicentre, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects with Relapsing-Remitting Multiple Sclerosis. - SELECT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
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. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).
- •2. Must be 18 to 55 years of age, inclusive, at the time of informed consent.
- •3. Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald
- •criteria #1-4 (Polman et al, 2005; Section 22).
- •4. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- •5. Must meet either of the following 2 criteria:
- •Have experienced at least 1 relapse within the 12 months prior to randomization,
- •with a cranial MRI demonstrating lesion(s) consistent with MS (it is not necessary to
- •obtain a current scan if a scan performed previously is available from the subject’s
- •history; if a scan is not available from the subject’s history, then the baseline scan
- •may be used). For inclusion purposes, a relapse is defined as neurologic signs and/or
- •symptoms documented by a neurologist in the medical record and of at least 24 Time since relapse should be measured from the time of relapse onset, OR
- •Show evidence of Gd-enhancing lesions of the brain on an MRI performed within
- •the 6 weeks prior to randomization (if scan is not available from the subject’s
- •history, then baseline scan may be used).
- •6. Must be disqualified from standard treatment for MS (sites in Poland only). Candidates in Poland must be from one of the following patient populations:
- •Patients who rejected standard treatment for MS,
- •Patients with contraindications for using standard treatment for MS,
- •Patients for whom standard treatment for MS has proven ineffective,
- •Patients who are on the waiting list for state-funded standard treatment for MS, but who will not receive standard treatment for the duration of the study (15 months).
- •7. Male subjects and female subjects of child-bearing potential must be willing to practice effective contraception during the study and be willing and able to continue
- •contraception for 4 months after their last dose of study treatment.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical History
- •1. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 2001 [Section 23]). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapses, but are distinguished from relapsing-remitting patients by the lack of clinically stable periods or clinical improvement.
- •2. History of malignancy; however, subjects with a history of excised or treated basal cell carcinoma or fewer than 3 squamous cell carcinomas are eligible to participate in this study.
- •3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
- •4. History of abnormal laboratory results that, in the opinion of the investigator, are
- •indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic,
- •psychiatric, renal, neurologic (other than MS), and/or other major disease that would
- •preclude administration of DAC HYP.
- •5. History of human immunodeficiency virus (HIV) or other immunodeficient conditions.
- •6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.
- •7. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.
- •8. Positive for hepatitis C virus (HCV) antibody and/or positive for hepatitis B surface
- •antigen (HBsAg) at Screening.
- •9. Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening.
- •10. Exposure to varicella zoster virus within 21 days before Screening.
- •11. Any of the following abnormal blood tests at Screening:
- •Hemoglobin =9.0 g/dL
- •Platelets =100 × 10^9/L
- •Lymphocytes =1.0 × 10^9/L
- •Neutrophils =1.5 × 10^9 /L
- •Alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT),
- •aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT),
- •or gamma-glutamyl-transferase >2 times the upper limit of normal (ULN)
- •Serum creatinine >ULN.
- •Treatment History
- •12. Any previous treatment with DAC HYP or Zenapax®.
- •13. Any of the following types of live virus vaccine from 4 weeks before randomization:
- •measles/mumps/rubella vaccine, varicella zoster virus vaccine, oral polio vaccine, and
- •nasal influenza vaccine. Use of these vaccines, however, by other members of the
- •subject’s household does not affect the eligibility of subjects to enroll or continue in the study.
- •14. Infection (viral, fungal, bacterial) requiring hospitalization or intravenous (IV)
- •antibiotics within 8 weeks before randomization.
- •15. Elective surgery performed from 2 weeks prior to randomization or scheduled through the end of the study.
- •16. Prior treatment with any of the following:
- •total lymphoid irradiation
- •cladribine
- •mitoxantrone
- •T-cell or T-cell receptor vaccination
- •any therapeutic monoclonal antibody, except natalizumab or rituximab.
- •17. Prior treatment with cyclophosphamide or rituximab within 1 year prior to
- •randomization.
- •18. Prior treatment with any of the following medications or procedures within the 6 months prior to randomization:
- •natalizumab
- •cyclosporine
- •azathioprine
- •methotrexate
- •intravenous immunoglobulin (IVIg)
- •plasmapheresis or cytapheresis.
- •19. Prior treatment with any of the following within the 3 months prior to randomization:
研究者
相似试验
尚未招募
2 期
Monotherapy Phase II Dose Ranging Study of DAC HYP in Relapsing Remitting Multiple SclerosisMultiple SclerosisACTRN12606000306516Biogen Idec264
进行中（未招募）
不适用
Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - Not applicableMultiple sclerosis (MS)EUCTR2006-001161-42-SEBiogen Idec Ltd.232
进行中（未招募）
不适用
Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECTMultiple sclerosis (MS)MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2006-001161-42-CZBiogen Idec Ltd.600
进行中（未招募）
不适用
A study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis.EUCTR2006-001161-42-DEBiogen Idec Ltd.600
进行中（未招募）
1 期
Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECTMultiple sclerosis (MS)MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2006-001161-42-GBBiogen Idec Ltd600