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
NCT ID: NCT01051349
Last Updated: 2018-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
410 participants
INTERVENTIONAL
2010-03-31
2016-08-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BIIB019
Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 288.
BIIB019 (Daclizumab)
Administered as specified in the treatment arm.
trivalent seasonal influenza vaccine
All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site
Interventions
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BIIB019 (Daclizumab)
Administered as specified in the treatment arm.
trivalent seasonal influenza vaccine
All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
60 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Brno, , Czechia
Research Site
Brno, , Czechia
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Hradec Králové, , Czechia
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Prague, , Czechia
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Teplice, , Czechia
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Bayreuth, , Germany
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Erlangen, , Germany
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Marburg, , Germany
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Rostock, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Esztergom, , Hungary
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Győr, , Hungary
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Kecskemét, , Hungary
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Miskolc, , Hungary
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Miskolc, , Hungary
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Nyíregyháza, , Hungary
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Siófok, , Hungary
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Bangalore, , India
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Hyderabad, , India
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Kolkata, , India
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Mumbai, , India
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Rajasthan, , India
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Bialystok, , Poland
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Bialystok, , Poland
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Gdansk, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Kazan', , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Omsk, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Smolensk, , Russia
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Ufa, , Russia
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Yaroskavi, , Russia
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Chernivtsi, , Ukraine
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Kharkiv, , Ukraine
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Kiev, , Ukraine
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Kiev, , Ukraine
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Kyiv, , Ukraine
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Poltava, , Ukraine
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Zaporizhia, , Ukraine
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Zaporizhia, , Ukraine
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London, , United Kingdom
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Nottingham, , United Kingdom
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Plymouth, , United Kingdom
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Sheffield, , United Kingdom
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Stoke-on-Trent, , United Kingdom
Countries
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References
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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.
Related Links
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The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS their families and healthcare providers
Other Identifiers
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2009-015318-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
205-MS-203
Identifier Type: -
Identifier Source: org_study_id
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