Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis (SELECTED)
2018年4月11日 更新者：Biogen
A Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)
Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS).
Secondary Objective is to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS) relapse, slowing disability progression, and reducing new MS lesion formation in this study population.
研究概览
详细说明
This study will provide participants who complete Study 205MS202 (NCT00870740) with the option to receive continued open-label Daclizumab High Yield Process (DAC HYP) monotherapy and to evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP monotherapy in participants with relapsing remitting multiple sclerosis (RRMS).
Approximately 60 to 100 participants will be enrolled into an optional open-label, 16-week autoinjector substudy at a selected subset of sites which will run concurrently during the main study, and will evaluate the systemic exposure and local tolerability of subcutaneous administration of DAC HYP by autoinjector.
The 2013-2014 trivalent influenza vaccine will be offered to all eligible participants as an optional substudy to assess the effect of DAC-HYP treatment on the immune response to vaccination,
研究类型
介入性
注册 (实际的)
410
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Chernivtsi、乌克兰、58018
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Dnipropetrovsk、乌克兰、49027
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Donetsk、乌克兰、83003
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Kharkiv、乌克兰、61068
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Kiev、乌克兰、03110
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Kiev、乌克兰、2125
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Kyiv、乌克兰、03110
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Poltava、乌克兰、36024
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Zaporizhia、乌克兰、69035
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Zaporizhia、乌克兰、69600
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Kazan、俄罗斯联邦、420021
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Krasnoyarsk、俄罗斯联邦、660049
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Moscow、俄罗斯联邦、107150
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Moscow、俄罗斯联邦、115682
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Moscow、俄罗斯联邦、6127018
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Nizhniy Novgorod、俄罗斯联邦、603076
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Novosibirsk、俄罗斯联邦、630087
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Omsk、俄罗斯联邦、644033
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Samara、俄罗斯联邦、443095
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Smolensk、俄罗斯联邦、214018
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St Petersburg、俄罗斯联邦、194291
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Ufa、俄罗斯联邦、450005
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Yaroskavi、俄罗斯联邦、150030
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Budapest、匈牙利、1083
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Budapest、匈牙利、1115
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Budapest、匈牙利、1125
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Budapest、匈牙利、1076
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Budapest、匈牙利、1134
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Debrecen、匈牙利、4032
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Esztergom、匈牙利、2500
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Gyor、匈牙利、9024
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Kecskemet、匈牙利、6000
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Miskolc、匈牙利、3526
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Miskolc、匈牙利、3533
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Nyiregyhaza、匈牙利、4400
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Siofok、匈牙利、8600
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Bangalore、印度、560034
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Hyderabad、印度、500082
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Kolkata、印度、700068
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Mumbai、印度、400012
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Rajasthan、印度、302021
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Bayreuth、德国、95445
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Erlangen、德国、91054
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Marburg、德国、35043
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Rostock、德国、18147
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Brno、捷克语、625 00
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Brno、捷克语、656 91
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Hradec Kralove、捷克语、500 02
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Prague、捷克语、100 34
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Teplice、捷克语、415 29
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Bialystok、波兰、15-276
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Bialystok、波兰、15-420
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Gdansk、波兰、80-803
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Katowice、波兰、40-749
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Katowice、波兰、40-752
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Krakow、波兰、31-505
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Lodz、波兰、93-121
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Lublin、波兰、20954
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Warsaw、波兰、02-957
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Warszawa、波兰、02-097
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London、英国、SE59RF
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Nottingham、英国、NG72UH
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Plymouth、英国、PL68DH
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Sheffield、英国、S102JF
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Stoke-on-Trent、英国、ST47LN
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Main Study Eligibility:
Key Inclusion Criteria:
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Subjects who have completed 52 weeks in Study 205MS202 (NCT00870740) and were compliant with the 205MS202 protocol in the opinion of the Investigator.
- Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.
Key Exclusion Criteria:
- Subjects with any significant change in their medical status from the previous study that would prelude administration of Daclizumab High Yield Process (DAC HYP) as determined by the Investigator including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in the 205MS201 (NCT00390221) or 205MS202 (NCT00870740) studies. The Investigator must re-review the subject's medical fitness for participation and must consider any diseases that would preclude treatment.
- Any subject who has permanently discontinued study treatment in Study 205MS202 (NCT00870740) due to an adverse event.
- Current enrollment in any investigational drug study other than Study 205MS202 (NCT00870740).
- Ongoing treatment with any approved or experimental disease-modifying treatment for multiple sclerosis.
For subjects currently taking valproic acid, carbamazepine, lamotrigine, or phenytoin:
- Subjects treated with any of these agents for fewer than 6 months prior to study entry are excluded from study participation unless they discontinue the agent(s) prior to study entry.
- Subjects treated with 2 or more of these agents for more than 6 months prior to study entry are excluded from study participation unless they reduce to ≤1 agent prior to study entry.
- Subjects who have had dose escalations of one of these agents within the 6 months prior to study entry are excluded from study participation unless they revert to a previous dose that had been used for at least 6 months prior to study entry or unless they discontinue the agent prior to study entry
- Subjects who are currently receiving treatment with isoniazid, propylthiouracil, or nimesulide at the time of study entry and are not able to discontinue the agent or change to an alternative medication allowed by the protocol.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：BIIB019
Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 288.
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Administered as specified in the treatment arm.
其他名称：
All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs
大体时间：Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)
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An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
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Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)
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Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab
大体时间：Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
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Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
大体时间：From Baseline through 288 weeks
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New or newly enlarging T2 hyperintense lesions evaluated by magnetic resonance imaging (MRI) and analyzed by a central reader.
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From Baseline through 288 weeks
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Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
大体时间：From Baseline through 288 weeks
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New or newly enlarging T2 hyperintense lesions evaluated by MRI and analyzed by a central reader.
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From Baseline through 288 weeks
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Number of Participants With Total Number of New Gadolinium-enhancing Lesions
大体时间：From Baseline through 288 weeks
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New Gadolinium-enhancing lesions was evaluated by MRI and analyzed by a central reader.
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From Baseline through 288 weeks
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Annual Change in Number of T1 Hypointense Lesions
大体时间：From Baseline through 288 weeks
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From Baseline through 288 weeks
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Annual Change in Volume of New Gadolinium-Enhancing Lesions
大体时间：From Baseline through 288 weeks
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From Baseline through 288 weeks
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Annual Change in Volume of T1 Hypointense Lesions
大体时间：From Baseline through 288 weeks
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Volume of T1 hypointense lesions was evaluated by MRI and analyzed by a central reader.
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From Baseline through 288 weeks
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Percent Change in Total Brain Volume
大体时间：From Baseline through 288 weeks
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To assess brain atrophy, total brain volume was be measured by MRI and analyzed by a central reader.
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From Baseline through 288 weeks
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Number of Participants With Antibodies to DAC HYP
大体时间：Up to Week 288
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Up to Week 288
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Annualized Relapse Rate (ARR)
大体时间：Week 288
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Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.
The ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.
Adjusted ARR was reported.
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Week 288
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Number of Participants With Sustained Disability Progression for 12 Weeks
大体时间：Week 48 up to Week 288
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Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 12 weeks.
The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.
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Week 48 up to Week 288
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Number of Participants With Sustained Disability Progression for 24 Weeks
大体时间：Week 48 up to Week 288
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Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 24 weeks.
The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.
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Week 48 up to Week 288
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Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab
大体时间：Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
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Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
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Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4
大体时间：Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
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Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
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Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4
大体时间：Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
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Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
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Participant-Reported Pain Visual Analog Scale (VAS) Score
大体时间：First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose
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The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end ("0 [no pain]" on the left and "100 [very painful]" on the right).
The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain.
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First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose
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Summary of Injection Site Assessment Performed by Clinician
大体时间：First injection (Day 1) and fourth injection (Day 90) 30 minutes; 8, 24, 72, and 120 hours; and 7, 10, and 14 days post-dose
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Injection site assessment was performed by clinician and are defined as erythema (redness) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; pigmentation changes (skin discoloration other than redness) rated on a 3 point scale from 0-2, where 0=none, 1=hypopigmentation and 2=hyperpigmentation; induration (swelling) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; tenderness to pressure rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; and local temperature changes of injection sites rated on a 3 point scale where 0=normal, 1=warm and 1=hot. Only those score categories for which there was at least 1 participant are reported. Here, Injection=Inj, post-dose=PD |
First injection (Day 1) and fourth injection (Day 90) 30 minutes; 8, 24, 72, and 120 hours; and 7, 10, and 14 days post-dose
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Gold R, Radue EW, Giovannoni G, Selmaj K, Havrdova EK, Montalban X, Stefoski D, Sprenger T, Robinson RR, Fam S, Smith J, Chalkias S, Giannattasio G, Lima G, Castro-Borrero W. Long-term safety and efficacy of daclizumab beta in relapsing-remitting multiple sclerosis: 6-year results from the SELECTED open-label extension study. J Neurol. 2020 Oct;267(10):2851-2864. doi: 10.1007/s00415-020-09835-y. Epub 2020 May 25.
- Gold R, Radue EW, Giovannoni G, Selmaj K, Havrdova E, Stefoski D, Sprenger T, Montalban X, Cohan S, Umans K, Greenberg SJ, Ozen G, Elkins J. Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study. BMC Neurol. 2016 Jul 26;16:117. doi: 10.1186/s12883-016-0635-y.
- Gold R, Stefoski D, Selmaj K, Havrdova E, Hurst C, Holman J, Tornesi B, Akella S, McCroskery P. Pregnancy Experience: Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program. Neurol Ther. 2016 Dec;5(2):169-182. doi: 10.1007/s40120-016-0048-2. Epub 2016 Jul 13.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2010年3月31日
初级完成 (实际的)
2016年8月25日
研究完成 (实际的)
2016年8月25日
研究注册日期
首次提交
2010年1月15日
首先提交符合 QC 标准的
2010年1月15日
首次发布 (估计)
2010年1月18日
研究记录更新
最后更新发布 (实际的)
2018年11月9日
上次提交的符合 QC 标准的更新
2018年4月11日
最后验证
2018年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.