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 april 2018 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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,
Studietype
Ingrijpend
Inschrijving (Werkelijk)
410
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Bayreuth, Duitsland, 95445
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Erlangen, Duitsland, 91054
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Marburg, Duitsland, 35043
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Rostock, Duitsland, 18147
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Budapest, Hongarije, 1083
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Budapest, Hongarije, 1115
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Budapest, Hongarije, 1125
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Budapest, Hongarije, 1076
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Budapest, Hongarije, 1134
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Debrecen, Hongarije, 4032
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Esztergom, Hongarije, 2500
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Gyor, Hongarije, 9024
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Kecskemet, Hongarije, 6000
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Miskolc, Hongarije, 3526
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Miskolc, Hongarije, 3533
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Nyiregyhaza, Hongarije, 4400
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Siofok, Hongarije, 8600
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Bangalore, Indië, 560034
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Hyderabad, Indië, 500082
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Kolkata, Indië, 700068
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Mumbai, Indië, 400012
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Rajasthan, Indië, 302021
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Chernivtsi, Oekraïne, 58018
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Dnipropetrovsk, Oekraïne, 49027
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Donetsk, Oekraïne, 83003
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Kharkiv, Oekraïne, 61068
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Kiev, Oekraïne, 03110
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Kiev, Oekraïne, 2125
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Kyiv, Oekraïne, 03110
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Poltava, Oekraïne, 36024
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Zaporizhia, Oekraïne, 69035
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Zaporizhia, Oekraïne, 69600
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Bialystok, Polen, 15-276
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Bialystok, Polen, 15-420
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Gdansk, Polen, 80-803
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Katowice, Polen, 40-749
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Katowice, Polen, 40-752
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Krakow, Polen, 31-505
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Lodz, Polen, 93-121
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Lublin, Polen, 20954
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Warsaw, Polen, 02-957
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Warszawa, Polen, 02-097
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Kazan, Russische Federatie, 420021
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Krasnoyarsk, Russische Federatie, 660049
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Moscow, Russische Federatie, 107150
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Moscow, Russische Federatie, 115682
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Moscow, Russische Federatie, 6127018
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Nizhniy Novgorod, Russische Federatie, 603076
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Novosibirsk, Russische Federatie, 630087
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Omsk, Russische Federatie, 644033
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Samara, Russische Federatie, 443095
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Smolensk, Russische Federatie, 214018
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St Petersburg, Russische Federatie, 194291
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Ufa, Russische Federatie, 450005
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Yaroskavi, Russische Federatie, 150030
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Brno, Tsjechië, 625 00
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Brno, Tsjechië, 656 91
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Hradec Kralove, Tsjechië, 500 02
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Prague, Tsjechië, 100 34
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Teplice, Tsjechië, 415 29
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London, Verenigd Koninkrijk, SE59RF
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Nottingham, Verenigd Koninkrijk, NG72UH
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Plymouth, Verenigd Koninkrijk, PL68DH
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Sheffield, Verenigd Koninkrijk, S102JF
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Stoke-on-Trent, Verenigd Koninkrijk, ST47LN
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 60 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
Andere namen:
All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to Week 288
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Up to Week 288
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Annualized Relapse Rate (ARR)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
31 maart 2010
Primaire voltooiing (Werkelijk)
25 augustus 2016
Studie voltooiing (Werkelijk)
25 augustus 2016
Studieregistratiedata
Eerst ingediend
15 januari 2010
Eerst ingediend dat voldeed aan de QC-criteria
15 januari 2010
Eerst geplaatst (Schatting)
18 januari 2010
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 november 2018
Laatste update ingediend die voldeed aan QC-criteria
11 april 2018
Laatst geverifieerd
1 april 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Ziekten van het zenuwstelsel
- Ziekten van het immuunsysteem
- Demyeliniserende auto-immuunziekten, CZS
- Auto-immuunziekten van het zenuwstelsel
- Demyeliniserende ziekten
- Auto-immuunziekten
- Multiple sclerose
- Sclerose
- Multiple sclerose, relapsing-remitting
- Fysiologische effecten van medicijnen
- Immunosuppressieve middelen
- Immunologische factoren
- Daclizumab
Andere studie-ID-nummers
- 205-MS-203
- 2009-015318-23 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .