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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01797965




Registration number
NCT01797965
Ethics application status
Date submitted
15/02/2013
Date registered
25/02/2013
Date last updated
4/12/2019

Titles & IDs
Public title
Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019
Scientific title
A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301
Secondary ID [1] 0 0
2012-003176-39
Secondary ID [2] 0 0
205MS303
Universal Trial Number (UTN)
Trial acronym
EXTEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis 0 0
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BIIB019 (Daclizumab)

Experimental: BIIB019 - BIIB019 150 mg subcutaneous (SC) every 4 weeks


Treatment: Drugs: BIIB019 (Daclizumab)
Participants will receive open-label treatment with BIIB019 150 mg subcutaneous injection every 4 weeks for up to 5 years.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years)
Secondary outcome [1] 0 0
Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period
Timepoint [1] 0 0
Up to 4.6 years in the 303 study
Secondary outcome [2] 0 0
ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period
Timepoint [2] 0 0
Up to 5.6 years combining 303 with the initial Study 301; Up to 1 year in the 301 study
Secondary outcome [3] 0 0
Number of Participants With Relapse in the 205MS303 Treatment Period
Timepoint [3] 0 0
Up to 4.6 years in the 303 study
Secondary outcome [4] 0 0
Number of Participants With Relapse in the 205MS301-303 Combined Study Period
Timepoint [4] 0 0
Up to 5.6 years combining 303 with the initial Study 301
Secondary outcome [5] 0 0
Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period
Timepoint [5] 0 0
Up to 4.6 years in Study 303
Secondary outcome [6] 0 0
Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period
Timepoint [6] 0 0
Up to 5.6 years combining 303 with the initial Study 301
Secondary outcome [7] 0 0
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period
Timepoint [7] 0 0
Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303
Secondary outcome [8] 0 0
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period
Timepoint [8] 0 0
Baseline 301, Weeks 24, 96, 144 in Study 301
Secondary outcome [9] 0 0
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period
Timepoint [9] 0 0
301-303: Baseline 303, Weeks 48, 96, 144, 192, 240; 203-303 and 302-303: Week 96
Secondary outcome [10] 0 0
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period
Timepoint [10] 0 0
Baseline 301, Weeks 24, 96 and 144
Secondary outcome [11] 0 0
Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period
Timepoint [11] 0 0
Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303
Secondary outcome [12] 0 0
Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period
Timepoint [12] 0 0
Baseline 301, Weeks 24, 96, 144 in Study 301
Secondary outcome [13] 0 0
Percent Change in Brain Volume From the 205MS303 Baseline
Timepoint [13] 0 0
Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303
Secondary outcome [14] 0 0
Percent Change in Brain Volume From 205MS301 Baseline
Timepoint [14] 0 0
Baseline 301, Weeks 48, 96, 144, 192, 240 in Study 303
Secondary outcome [15] 0 0
Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period
Timepoint [15] 0 0
Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303; 203-303 and 302-303: Week 96
Secondary outcome [16] 0 0
Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period
Timepoint [16] 0 0
Baseline 303, Weeks 12, 24 and 48 in Study 303
Secondary outcome [17] 0 0
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period
Timepoint [17] 0 0
Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48 in the 303 study
Secondary outcome [18] 0 0
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period
Timepoint [18] 0 0
301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 260; 203-303 and 302-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 116 in Study 303
Secondary outcome [19] 0 0
Number of Participants Who Are Free From Disease Activity in the 205MS303 Treatment Period
Timepoint [19] 0 0
Up to 4.6 years in Study 303
Secondary outcome [20] 0 0
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period
Timepoint [20] 0 0
Baseline 303, Weeks 12, 24, 48, 96, 120 and 144
Secondary outcome [21] 0 0
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period
Timepoint [21] 0 0
301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303
Secondary outcome [22] 0 0
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period
Timepoint [22] 0 0
301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 44, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303
Secondary outcome [23] 0 0
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period
Timepoint [23] 0 0
301-303: Baseline 303, Weeks 24, 48, 96, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48, 96 in 303
Secondary outcome [24] 0 0
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period
Timepoint [24] 0 0
Baseline 301, Weeks 24, 48, 72, 96, 120 and 144 in 301
Secondary outcome [25] 0 0
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period
Timepoint [25] 0 0
Baseline 303, Weeks 12, 24, 48, 72, 96, 120 in Study 303
Secondary outcome [26] 0 0
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period
Timepoint [26] 0 0
301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Secondary outcome [27] 0 0
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period
Timepoint [27] 0 0
301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Secondary outcome [28] 0 0
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period
Timepoint [28] 0 0
301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Secondary outcome [29] 0 0
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period
Timepoint [29] 0 0
301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Secondary outcome [30] 0 0
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period
Timepoint [30] 0 0
301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Secondary outcome [31] 0 0
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period
Timepoint [31] 0 0
301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Secondary outcome [32] 0 0
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period
Timepoint [32] 0 0
301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Secondary outcome [33] 0 0
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period
Timepoint [33] 0 0
301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Secondary outcome [34] 0 0
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period
Timepoint [34] 0 0
Up to 4.6 years in 303
Secondary outcome [35] 0 0
Local Tolerability as Assessed by Participant-reported Injection Site Pain VAS
Timepoint [35] 0 0
After the first and fourth injections in 303, approximately Week 0 and Week 12
Secondary outcome [36] 0 0
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories
Timepoint [36] 0 0
After the first and fourth injections in 303, approximately Week 0 and Week 12
Secondary outcome [37] 0 0
Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period
Timepoint [37] 0 0
Up to 4.6 years in the 303 Treatment Period
Secondary outcome [38] 0 0
Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period
Timepoint [38] 0 0
Up to 4.6 years in the 303 Treatment Period
Secondary outcome [39] 0 0
Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period
Timepoint [39] 0 0
Baseline 303, Weeks 144, 168, 192, 240 in 303
Secondary outcome [40] 0 0
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period
Timepoint [40] 0 0
Baseline 301, Weeks 24, 48, 72, 96, 120, 144 in 301; Weeks 144, 168, 192, 216, 240 in 303
Secondary outcome [41] 0 0
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period
Timepoint [41] 0 0
Baseline 303, Weeks 12, 24, 48, 120, 144, 168, 192, 216, 240 in 303
Secondary outcome [42] 0 0
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period
Timepoint [42] 0 0
Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48, 120, 144,168, 192, 216, 240 in 303 study

Eligibility
Key inclusion criteria
Key

* Must be a subject currently participating in Study 205MS301 (NCT01064401), or subject currently participating in Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) who has completed End of Study Visit (Week 96 or later).
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any subject who permanently discontinued study treatment in Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) prior to the end of the study treatment period, or had an Early Termination visit in Study 205MS301, Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).
* Any significant change in the subject's medical history that would preclude administration of BIIB019, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).

The Investigator must re review the subject's medical fitness for participation and consider any factors that would preclude treatment in this Study 205MS303.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/09/2018
Sample size
Target
Accrual to date
Final
1501
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Research Site - Auchenflower
Recruitment hospital [2] 0 0
Research Site - Heidelberg
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
New Hampshire
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
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Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Mendoza
Country [26] 0 0
Argentina
State/province [26] 0 0
Santa Fe
Country [27] 0 0
Brazil
State/province [27] 0 0
Minas Gerais
Country [28] 0 0
Brazil
State/province [28] 0 0
Pernambuco
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio Grande Do Sul
Country [30] 0 0
Brazil
State/province [30] 0 0
São Paulo
Country [31] 0 0
Brazil
State/province [31] 0 0
Rio de Janeiro
Country [32] 0 0
Brazil
State/province [32] 0 0
Rio De Janeiro
Country [33] 0 0
Canada
State/province [33] 0 0
British Columbia
Country [34] 0 0
Canada
State/province [34] 0 0
Newfoundland and Labrador
Country [35] 0 0
Canada
State/province [35] 0 0
Ontario
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
Czechia
State/province [37] 0 0
Jihomoravský Kraj
Country [38] 0 0
Czechia
State/province [38] 0 0
Kray Vysocina
Country [39] 0 0
Czechia
State/province [39] 0 0
Moravskoslezský Kraj
Country [40] 0 0
Czechia
State/province [40] 0 0
Pardubický Kraj
Country [41] 0 0
Czechia
State/province [41] 0 0
Praha
Country [42] 0 0
Czechia
State/province [42] 0 0
Severomoravsky Kraj
Country [43] 0 0
Czechia
State/province [43] 0 0
Hradec Kralove
Country [44] 0 0
Czechia
State/province [44] 0 0
Praha 5
Country [45] 0 0
Czechia
State/province [45] 0 0
Ústecký Kraj
Country [46] 0 0
Denmark
State/province [46] 0 0
Copenhagen
Country [47] 0 0
Denmark
State/province [47] 0 0
Glostrup
Country [48] 0 0
Denmark
State/province [48] 0 0
Odense C
Country [49] 0 0
France
State/province [49] 0 0
Bas-Rhin
Country [50] 0 0
France
State/province [50] 0 0
Bouches-du-Rhône
Country [51] 0 0
France
State/province [51] 0 0
Calvados
Country [52] 0 0
France
State/province [52] 0 0
Gironde
Country [53] 0 0
France
State/province [53] 0 0
Haute-Garonne
Country [54] 0 0
France
State/province [54] 0 0
Ile-de-France
Country [55] 0 0
France
State/province [55] 0 0
Meurthe-et-Moselle
Country [56] 0 0
France
State/province [56] 0 0
Nord
Country [57] 0 0
France
State/province [57] 0 0
Amiens Cedex 1
Country [58] 0 0
France
State/province [58] 0 0
Paris
Country [59] 0 0
Georgia
State/province [59] 0 0
Tbilisi
Country [60] 0 0
Germany
State/province [60] 0 0
Baden-Württemberg
Country [61] 0 0
Germany
State/province [61] 0 0
Bayern
Country [62] 0 0
Germany
State/province [62] 0 0
Hessen
Country [63] 0 0
Germany
State/province [63] 0 0
Mecklenburg-Vorpommern
Country [64] 0 0
Germany
State/province [64] 0 0
Sachsen
Country [65] 0 0
Germany
State/province [65] 0 0
Bamberg
Country [66] 0 0
Greece
State/province [66] 0 0
Attiki
Country [67] 0 0
Greece
State/province [67] 0 0
Macedonia
Country [68] 0 0
Greece
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Athens
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Greece
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Thessaloniki
Country [70] 0 0
Hungary
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Borsod-Abaúj-Zemplén
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Hungary
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Bács-Kiskun
Country [72] 0 0
Hungary
State/province [72] 0 0
Fejer
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Hungary
State/province [73] 0 0
Balatonfüred
Country [74] 0 0
Hungary
State/province [74] 0 0
Budapest
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Hungary
State/province [75] 0 0
Debrecen
Country [76] 0 0
Hungary
State/province [76] 0 0
Esztergom
Country [77] 0 0
Hungary
State/province [77] 0 0
Gyor
Country [78] 0 0
Hungary
State/province [78] 0 0
Miskolc
Country [79] 0 0
Hungary
State/province [79] 0 0
Nyíregyháza
Country [80] 0 0
India
State/province [80] 0 0
Andhra Pradesh
Country [81] 0 0
India
State/province [81] 0 0
Karnataka
Country [82] 0 0
India
State/province [82] 0 0
Kerala
Country [83] 0 0
India
State/province [83] 0 0
Maharashtra
Country [84] 0 0
India
State/province [84] 0 0
Gurgaon
Country [85] 0 0
Ireland
State/province [85] 0 0
Dublin
Country [86] 0 0
Israel
State/province [86] 0 0
Ashkelon
Country [87] 0 0
Israel
State/province [87] 0 0
Haifa
Country [88] 0 0
Israel
State/province [88] 0 0
Petah Tikva
Country [89] 0 0
Israel
State/province [89] 0 0
Safed
Country [90] 0 0
Italy
State/province [90] 0 0
Liguria
Country [91] 0 0
Italy
State/province [91] 0 0
Lombardia
Country [92] 0 0
Italy
State/province [92] 0 0
Veneto
Country [93] 0 0
Italy
State/province [93] 0 0
Catania
Country [94] 0 0
Italy
State/province [94] 0 0
Cefalù
Country [95] 0 0
Italy
State/province [95] 0 0
Roma
Country [96] 0 0
Mexico
State/province [96] 0 0
Distrito Federal
Country [97] 0 0
Moldova, Republic of
State/province [97] 0 0
Chisinau
Country [98] 0 0
Poland
State/province [98] 0 0
Kujawsko-pomorskie
Country [99] 0 0
Poland
State/province [99] 0 0
Lubelskie
Country [100] 0 0
Poland
State/province [100] 0 0
Lódzkie
Country [101] 0 0
Poland
State/province [101] 0 0
Malopolskie
Country [102] 0 0
Poland
State/province [102] 0 0
Mazowieckie
Country [103] 0 0
Poland
State/province [103] 0 0
Podlaskie
Country [104] 0 0
Poland
State/province [104] 0 0
Pomorskie
Country [105] 0 0
Poland
State/province [105] 0 0
Slaskie
Country [106] 0 0
Poland
State/province [106] 0 0
Swietokrzyskie
Country [107] 0 0
Poland
State/province [107] 0 0
Warminsko-mazurskie
Country [108] 0 0
Poland
State/province [108] 0 0
Wielkopolskie
Country [109] 0 0
Poland
State/province [109] 0 0
Zachodniopomorskie
Country [110] 0 0
Poland
State/province [110] 0 0
Gdansk
Country [111] 0 0
Poland
State/province [111] 0 0
Grudziadz
Country [112] 0 0
Poland
State/province [112] 0 0
Katowice
Country [113] 0 0
Poland
State/province [113] 0 0
Olsztyn
Country [114] 0 0
Romania
State/province [114] 0 0
Cluj
Country [115] 0 0
Romania
State/province [115] 0 0
Mures
Country [116] 0 0
Romania
State/province [116] 0 0
Timis
Country [117] 0 0
Romania
State/province [117] 0 0
Bucharest
Country [118] 0 0
Romania
State/province [118] 0 0
Iasi
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Yaroslavlr
Country [120] 0 0
Russian Federation
State/province [120] 0 0
Kazan
Country [121] 0 0
Russian Federation
State/province [121] 0 0
Kemerovo
Country [122] 0 0
Russian Federation
State/province [122] 0 0
Krasnoyarsk
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Moscow
Country [124] 0 0
Russian Federation
State/province [124] 0 0
Nizhny Novgorod
Country [125] 0 0
Russian Federation
State/province [125] 0 0
Novosibirsk
Country [126] 0 0
Russian Federation
State/province [126] 0 0
Omsk
Country [127] 0 0
Russian Federation
State/province [127] 0 0
Perm
Country [128] 0 0
Russian Federation
State/province [128] 0 0
Samara
Country [129] 0 0
Russian Federation
State/province [129] 0 0
Smolensk
Country [130] 0 0
Russian Federation
State/province [130] 0 0
St. Petersburg
Country [131] 0 0
Russian Federation
State/province [131] 0 0
Tyumen
Country [132] 0 0
Russian Federation
State/province [132] 0 0
Ufa
Country [133] 0 0
Serbia
State/province [133] 0 0
Belgrade
Country [134] 0 0
Serbia
State/province [134] 0 0
Kragujevac
Country [135] 0 0
Serbia
State/province [135] 0 0
Nis
Country [136] 0 0
Serbia
State/province [136] 0 0
Novi Sad
Country [137] 0 0
Spain
State/province [137] 0 0
Barcelona
Country [138] 0 0
Spain
State/province [138] 0 0
Córdoba
Country [139] 0 0
Spain
State/province [139] 0 0
Madrid, Communidad Delaware
Country [140] 0 0
Spain
State/province [140] 0 0
Girona
Country [141] 0 0
Spain
State/province [141] 0 0
l'Hospitalet de Llobregat
Country [142] 0 0
Spain
State/province [142] 0 0
Sevilla
Country [143] 0 0
Sweden
State/province [143] 0 0
Skane
Country [144] 0 0
Sweden
State/province [144] 0 0
Sodermanlands Lan
Country [145] 0 0
Sweden
State/province [145] 0 0
Vastra Gotalands Lan
Country [146] 0 0
Sweden
State/province [146] 0 0
Stockholm
Country [147] 0 0
Switzerland
State/province [147] 0 0
Basel-Stadt (de)
Country [148] 0 0
Ukraine
State/province [148] 0 0
Chernivets'ka Oblast
Country [149] 0 0
Ukraine
State/province [149] 0 0
Dnipropetrovs'ka Oblast'
Country [150] 0 0
Ukraine
State/province [150] 0 0
Donets'ka Oblast'
Country [151] 0 0
Ukraine
State/province [151] 0 0
Kharkivs'ka Oblast'
Country [152] 0 0
Ukraine
State/province [152] 0 0
Kyïv
Country [153] 0 0
Ukraine
State/province [153] 0 0
Odes'ka Oblast
Country [154] 0 0
Ukraine
State/province [154] 0 0
Poltavs'ka Oblast
Country [155] 0 0
Ukraine
State/province [155] 0 0
Vinnyts'ka Oblast'
Country [156] 0 0
Ukraine
State/province [156] 0 0
Zaporiz'ka Oblast'
Country [157] 0 0
Ukraine
State/province [157] 0 0
Zaporizhia Oblast
Country [158] 0 0
Ukraine
State/province [158] 0 0
Kharkiv
Country [159] 0 0
United Kingdom
State/province [159] 0 0
Devon
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Edinburgh, City Of
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Brighton
Country [162] 0 0
United Kingdom
State/province [162] 0 0
London
Country [163] 0 0
United Kingdom
State/province [163] 0 0
Nottingham
Country [164] 0 0
United Kingdom
State/province [164] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).

Secondary objectives of this study in this study population are as follows:

To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon ß-1a (Avonex) in Study 205MS301(NCT01064401).
Trial website
https://clinicaltrials.gov/study/NCT01797965
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01797965