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)
2018년 4월 11일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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,
연구 유형
중재적
등록 (실제)
410
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Bayreuth, 독일, 95445
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Erlangen, 독일, 91054
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Marburg, 독일, 35043
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Rostock, 독일, 18147
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Kazan, 러시아 연방, 420021
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Krasnoyarsk, 러시아 연방, 660049
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Moscow, 러시아 연방, 107150
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Moscow, 러시아 연방, 115682
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Moscow, 러시아 연방, 6127018
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Nizhniy Novgorod, 러시아 연방, 603076
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Novosibirsk, 러시아 연방, 630087
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Omsk, 러시아 연방, 644033
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Samara, 러시아 연방, 443095
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Smolensk, 러시아 연방, 214018
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St Petersburg, 러시아 연방, 194291
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Ufa, 러시아 연방, 450005
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Yaroskavi, 러시아 연방, 150030
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London, 영국, SE59RF
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Nottingham, 영국, NG72UH
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Plymouth, 영국, PL68DH
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Sheffield, 영국, S102JF
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Stoke-on-Trent, 영국, ST47LN
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Chernivtsi, 우크라이나, 58018
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Dnipropetrovsk, 우크라이나, 49027
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Donetsk, 우크라이나, 83003
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Kharkiv, 우크라이나, 61068
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Kiev, 우크라이나, 03110
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Kiev, 우크라이나, 2125
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Kyiv, 우크라이나, 03110
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Poltava, 우크라이나, 36024
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Zaporizhia, 우크라이나, 69035
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Zaporizhia, 우크라이나, 69600
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Bangalore, 인도, 560034
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Hyderabad, 인도, 500082
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Kolkata, 인도, 700068
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Mumbai, 인도, 400012
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Rajasthan, 인도, 302021
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Brno, 체코, 625 00
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Brno, 체코, 656 91
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Hradec Kralove, 체코, 500 02
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Prague, 체코, 100 34
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Teplice, 체코, 415 29
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Bialystok, 폴란드, 15-276
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Bialystok, 폴란드, 15-420
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Gdansk, 폴란드, 80-803
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Katowice, 폴란드, 40-749
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Katowice, 폴란드, 40-752
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Krakow, 폴란드, 31-505
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Lodz, 폴란드, 93-121
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Lublin, 폴란드, 20954
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Warsaw, 폴란드, 02-957
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Warszawa, 폴란드, 02-097
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Budapest, 헝가리, 1083
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Budapest, 헝가리, 1115
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Budapest, 헝가리, 1125
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Budapest, 헝가리, 1076
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Budapest, 헝가리, 1134
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Debrecen, 헝가리, 4032
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Esztergom, 헝가리, 2500
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Gyor, 헝가리, 9024
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Kecskemet, 헝가리, 6000
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Miskolc, 헝가리, 3526
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Miskolc, 헝가리, 3533
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Nyiregyhaza, 헝가리, 4400
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Siofok, 헝가리, 8600
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Up to Week 288
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Up to Week 288
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Annualized Relapse Rate (ARR)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2010년 3월 31일
기본 완료 (실제)
2016년 8월 25일
연구 완료 (실제)
2016년 8월 25일
연구 등록 날짜
최초 제출
2010년 1월 15일
QC 기준을 충족하는 최초 제출
2010년 1월 15일
처음 게시됨 (추정)
2010년 1월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 11월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 4월 11일
마지막으로 확인됨
2018년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 205-MS-203
- 2009-015318-23 (EudraCT 번호)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .