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)
11 de abril de 2018 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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,
Tipo de estudo
Intervencional
Inscrição (Real)
410
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Bayreuth, Alemanha, 95445
- Research Site
-
Erlangen, Alemanha, 91054
- Research Site
-
Marburg, Alemanha, 35043
- Research Site
-
Rostock, Alemanha, 18147
- Research Site
-
-
-
-
-
Kazan, Federação Russa, 420021
- Research Site
-
Krasnoyarsk, Federação Russa, 660049
- Research Site
-
Moscow, Federação Russa, 107150
- Research Site
-
Moscow, Federação Russa, 115682
- Research Site
-
Moscow, Federação Russa, 6127018
- Research Site
-
Nizhniy Novgorod, Federação Russa, 603076
- Research Site
-
Novosibirsk, Federação Russa, 630087
- Research Site
-
Omsk, Federação Russa, 644033
- Research Site
-
Samara, Federação Russa, 443095
- Research Site
-
Smolensk, Federação Russa, 214018
- Research Site
-
St Petersburg, Federação Russa, 194291
- Research Site
-
Ufa, Federação Russa, 450005
- Research Site
-
Yaroskavi, Federação Russa, 150030
- Research Site
-
-
-
-
-
Budapest, Hungria, 1083
- Research Site
-
Budapest, Hungria, 1115
- Research Site
-
Budapest, Hungria, 1125
- Research Site
-
Budapest, Hungria, 1076
- Research Site
-
Budapest, Hungria, 1134
- Research Site
-
Debrecen, Hungria, 4032
- Research Site
-
Esztergom, Hungria, 2500
- Research Site
-
Gyor, Hungria, 9024
- Research Site
-
Kecskemet, Hungria, 6000
- Research Site
-
Miskolc, Hungria, 3526
- Research Site
-
Miskolc, Hungria, 3533
- Research Site
-
Nyiregyhaza, Hungria, 4400
- Research Site
-
Siofok, Hungria, 8600
- Research Site
-
-
-
-
-
Bialystok, Polônia, 15-276
- Research Site
-
Bialystok, Polônia, 15-420
- Research Site
-
Gdansk, Polônia, 80-803
- Research Site
-
Katowice, Polônia, 40-749
- Research Site
-
Katowice, Polônia, 40-752
- Research Site
-
Krakow, Polônia, 31-505
- Research Site
-
Lodz, Polônia, 93-121
- Research Site
-
Lublin, Polônia, 20954
- Research Site
-
Warsaw, Polônia, 02-957
- Research Site
-
Warszawa, Polônia, 02-097
- Research Site
-
-
-
-
-
London, Reino Unido, SE59RF
- Research Site
-
Nottingham, Reino Unido, NG72UH
- Research Site
-
Plymouth, Reino Unido, PL68DH
- Research Site
-
Sheffield, Reino Unido, S102JF
- Research Site
-
Stoke-on-Trent, Reino Unido, ST47LN
- Research Site
-
-
-
-
-
Brno, Tcheca, 625 00
- Research Site
-
Brno, Tcheca, 656 91
- Research Site
-
Hradec Kralove, Tcheca, 500 02
- Research Site
-
Prague, Tcheca, 100 34
- Research Site
-
Teplice, Tcheca, 415 29
- Research Site
-
-
-
-
-
Chernivtsi, Ucrânia, 58018
- Research Site
-
Dnipropetrovsk, Ucrânia, 49027
- Research Site
-
Donetsk, Ucrânia, 83003
- Research Site
-
Kharkiv, Ucrânia, 61068
- Research Site
-
Kiev, Ucrânia, 03110
- Research Site
-
Kiev, Ucrânia, 2125
- Research Site
-
Kyiv, Ucrânia, 03110
- Research Site
-
Poltava, Ucrânia, 36024
- Research Site
-
Zaporizhia, Ucrânia, 69035
- Research Site
-
Zaporizhia, Ucrânia, 69600
- Research Site
-
-
-
-
-
Bangalore, Índia, 560034
- Research Site
-
Hyderabad, Índia, 500082
- Research Site
-
Kolkata, Índia, 700068
- Research Site
-
Mumbai, Índia, 400012
- Research Site
-
Rajasthan, Índia, 302021
- Research Site
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 60 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: BIIB019
Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 288.
|
Administered as specified in the treatment arm.
Outros nomes:
All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs
Prazo: Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)
|
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.
|
Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)
|
|
Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab
Prazo: 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
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
Prazo: From Baseline through 288 weeks
|
New or newly enlarging T2 hyperintense lesions evaluated by magnetic resonance imaging (MRI) and analyzed by a central reader.
|
From Baseline through 288 weeks
|
|
Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
Prazo: From Baseline through 288 weeks
|
New or newly enlarging T2 hyperintense lesions evaluated by MRI and analyzed by a central reader.
|
From Baseline through 288 weeks
|
|
Number of Participants With Total Number of New Gadolinium-enhancing Lesions
Prazo: From Baseline through 288 weeks
|
New Gadolinium-enhancing lesions was evaluated by MRI and analyzed by a central reader.
|
From Baseline through 288 weeks
|
|
Annual Change in Number of T1 Hypointense Lesions
Prazo: From Baseline through 288 weeks
|
From Baseline through 288 weeks
|
|
|
Annual Change in Volume of New Gadolinium-Enhancing Lesions
Prazo: From Baseline through 288 weeks
|
From Baseline through 288 weeks
|
|
|
Annual Change in Volume of T1 Hypointense Lesions
Prazo: From Baseline through 288 weeks
|
Volume of T1 hypointense lesions was evaluated by MRI and analyzed by a central reader.
|
From Baseline through 288 weeks
|
|
Percent Change in Total Brain Volume
Prazo: From Baseline through 288 weeks
|
To assess brain atrophy, total brain volume was be measured by MRI and analyzed by a central reader.
|
From Baseline through 288 weeks
|
|
Number of Participants With Antibodies to DAC HYP
Prazo: Up to Week 288
|
Up to Week 288
|
|
|
Annualized Relapse Rate (ARR)
Prazo: Week 288
|
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.
|
Week 288
|
|
Number of Participants With Sustained Disability Progression for 12 Weeks
Prazo: Week 48 up to Week 288
|
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.
|
Week 48 up to Week 288
|
|
Number of Participants With Sustained Disability Progression for 24 Weeks
Prazo: Week 48 up to Week 288
|
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.
|
Week 48 up to Week 288
|
|
Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab
Prazo: 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
|
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
|
|
|
Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4
Prazo: 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
|
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
|
|
|
Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4
Prazo: 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
|
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
|
|
|
Participant-Reported Pain Visual Analog Scale (VAS) Score
Prazo: First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose
|
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.
|
First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose
|
|
Summary of Injection Site Assessment Performed by Clinician
Prazo: 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
|
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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
31 de março de 2010
Conclusão Primária (Real)
25 de agosto de 2016
Conclusão do estudo (Real)
25 de agosto de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
15 de janeiro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de janeiro de 2010
Primeira postagem (Estimativa)
18 de janeiro de 2010
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de novembro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de abril de 2018
Última verificação
1 de abril de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Doenças do Sistema Nervoso
- Doenças do sistema imunológico
- Doenças Autoimunes Desmielinizantes, SNC
- Doenças Autoimunes do Sistema Nervoso
- Doenças Desmielinizantes
- Doenças autoimunes
- Esclerose múltipla
- Esclerose
- Esclerose Múltipla Recorrente-Remitente
- Efeitos Fisiológicos das Drogas
- Agentes imunossupressores
- Fatores imunológicos
- Daclizumabe
Outros números de identificação do estudo
- 205-MS-203
- 2009-015318-23 (Número EudraCT)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em BIIB019 (Daclizumab)
-
BiogenAbbVieRescindidoEsclerose múltipla | Esclerose Múltipla Recorrente-RemitenteEstados Unidos, Dinamarca, Itália, Reino Unido, Tcheca, Canadá, Hungria, Espanha, Austrália, Israel, Geórgia, Sérvia, Federação Russa, Ucrânia, Índia, Polônia, Brasil, França, Argentina, Alemanha, Grécia, Irlanda, México, Moldávia, República... e mais
-
BiogenAbbVieConcluídoEsclerose Múltipla Recorrente-RemitenteRepública Checa, Polônia, Federação Russa, Reino Unido, Hungria, Ucrânia, Alemanha, Índia
-
BiogenAbbVieConcluídoEsclerose Múltipla Recorrente-RemitenteRepública Checa, Polônia, Federação Russa, Reino Unido, Hungria, Ucrânia, Alemanha, Índia
-
BiogenConcluídoEsclerose Múltipla Recorrente-RemitentePolônia, Hungria, Estados Unidos, República Checa
-
BiogenAbbVieConcluídoEsclerose Múltipla Recorrente-RemitenteSuécia, Estados Unidos, Brasil, República Checa, Itália, Federação Russa, Espanha, Reino Unido, Alemanha, Ucrânia, Dinamarca, Finlândia, Romênia, Canadá, França, Hungria, Israel, Suíça, Sérvia, Índia, México, Polônia, Geórgia, Irlanda, Ar... e mais