Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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. dubna 2018 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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,

Typ studie

Intervenční

Zápis (Aktuální)

410

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Indie
      • Bangalore, Indie, 560034
        • Research Site
      • Hyderabad, Indie, 500082
        • Research Site
      • Kolkata, Indie, 700068
        • Research Site
      • Mumbai, Indie, 400012
        • Research Site
      • Rajasthan, Indie, 302021
        • Research Site
  • Maďarsko
      • Budapest, Maďarsko, 1083
        • Research Site
      • Budapest, Maďarsko, 1115
        • Research Site
      • Budapest, Maďarsko, 1125
        • Research Site
      • Budapest, Maďarsko, 1076
        • Research Site
      • Budapest, Maďarsko, 1134
        • Research Site
      • Debrecen, Maďarsko, 4032
        • Research Site
      • Esztergom, Maďarsko, 2500
        • Research Site
      • Gyor, Maďarsko, 9024
        • Research Site
      • Kecskemet, Maďarsko, 6000
        • Research Site
      • Miskolc, Maďarsko, 3526
        • Research Site
      • Miskolc, Maďarsko, 3533
        • Research Site
      • Nyiregyhaza, Maďarsko, 4400
        • Research Site
      • Siofok, Maďarsko, 8600
        • Research Site
  • Německo
      • Bayreuth, Německo, 95445
        • Research Site
      • Erlangen, Německo, 91054
        • Research Site
      • Marburg, Německo, 35043
        • Research Site
      • Rostock, Německo, 18147
        • Research Site
  • Polsko
      • Bialystok, Polsko, 15-276
        • Research Site
      • Bialystok, Polsko, 15-420
        • Research Site
      • Gdansk, Polsko, 80-803
        • Research Site
      • Katowice, Polsko, 40-749
        • Research Site
      • Katowice, Polsko, 40-752
        • Research Site
      • Krakow, Polsko, 31-505
        • Research Site
      • Lodz, Polsko, 93-121
        • Research Site
      • Lublin, Polsko, 20954
        • Research Site
      • Warsaw, Polsko, 02-957
        • Research Site
      • Warszawa, Polsko, 02-097
        • Research Site
  • Ruská Federace
      • Kazan, Ruská Federace, 420021
        • Research Site
      • Krasnoyarsk, Ruská Federace, 660049
        • Research Site
      • Moscow, Ruská Federace, 107150
        • Research Site
      • Moscow, Ruská Federace, 115682
        • Research Site
      • Moscow, Ruská Federace, 6127018
        • Research Site
      • Nizhniy Novgorod, Ruská Federace, 603076
        • Research Site
      • Novosibirsk, Ruská Federace, 630087
        • Research Site
      • Omsk, Ruská Federace, 644033
        • Research Site
      • Samara, Ruská Federace, 443095
        • Research Site
      • Smolensk, Ruská Federace, 214018
        • Research Site
      • St Petersburg, Ruská Federace, 194291
        • Research Site
      • Ufa, Ruská Federace, 450005
        • Research Site
      • Yaroskavi, Ruská Federace, 150030
        • Research Site
  • Spojené království
      • London, Spojené království, SE59RF
        • Research Site
      • Nottingham, Spojené království, NG72UH
        • Research Site
      • Plymouth, Spojené království, PL68DH
        • Research Site
      • Sheffield, Spojené království, S102JF
        • Research Site
      • Stoke-on-Trent, Spojené království, ST47LN
        • Research Site
  • Ukrajina
      • Chernivtsi, Ukrajina, 58018
        • Research Site
      • Dnipropetrovsk, Ukrajina, 49027
        • Research Site
      • Donetsk, Ukrajina, 83003
        • Research Site
      • Kharkiv, Ukrajina, 61068
        • Research Site
      • Kiev, Ukrajina, 03110
        • Research Site
      • Kiev, Ukrajina, 2125
        • Research Site
      • Kyiv, Ukrajina, 03110
        • Research Site
      • Poltava, Ukrajina, 36024
        • Research Site
      • Zaporizhia, Ukrajina, 69035
        • Research Site
      • Zaporizhia, Ukrajina, 69600
        • Research Site
  • Česko
      • Brno, Česko, 625 00
        • Research Site
      • Brno, Česko, 656 91
        • Research Site
      • Hradec Kralove, Česko, 500 02
        • Research Site
      • Prague, Česko, 100 34
        • Research Site
      • Teplice, Česko, 415 29
        • Research Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 60 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: BIIB019
Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 288.
Biologický: BIIB019 (Daclizumab)
Administered as specified in the treatment arm.
Ostatní jména:
  • Proces s vysokým výnosem daklizumabu
  • DAC HYP
Biologický: trivalent seasonal influenza vaccine
All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: From Baseline through 288 weeks
From Baseline through 288 weeks
Annual Change in Volume of New Gadolinium-Enhancing Lesions
Časové okno: From Baseline through 288 weeks
From Baseline through 288 weeks
Annual Change in Volume of T1 Hypointense Lesions
Časové okno: 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
Časové okno: 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
Časové okno: Up to Week 288
Up to Week 288
Annualized Relapse Rate (ARR)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Biogen

Spolupracovníci

AbbVie

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

31. března 2010

Primární dokončení (Aktuální)

25. srpna 2016

Dokončení studie (Aktuální)

25. srpna 2016

Termíny zápisu do studia

První předloženo

15. ledna 2010

První předloženo, které splnilo kritéria kontroly kvality

15. ledna 2010

První zveřejněno (Odhad)

18. ledna 2010

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. listopadu 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. dubna 2018

Naposledy ověřeno

1. dubna 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 205-MS-203
  • 2009-015318-23 (Číslo EudraCT)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na BIIB019 (Daclizumab)

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Belarus

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit