Clinical trial NCT01797965: Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2013-02-25
Enrollment: 1501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 β-1a (Avonex) in Study 205MS301(NCT01064401).

Detailed description: Enrollment will include up to 1600 Participants, this includes approximately 1200 Participants who completed Study 205MS301 (NCT01064401). Additionally, approximately 400 Participants from the other BIIB019 extension studies 205MS203 (NCT01051349) and 205MS302 (NCT01462318) will be eligible to enter Study 205MS303 at Week 144 of Study 205MS303 \[Study 205MS301 (NCT01064401), study 205MS203 (NCT01051349) and study 205MS302 (NCT01462318) have been referred to as parent studies in the protocol\]. All Participants will receive the same dose of DAC HYP as received in the parent studies; i.e., 150 mg by an SC injection every 4 weeks.

Eligibility criteria: Key Inclusion Criteria:

* 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 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years)
Secondary outcomes:
measure: Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period
timeFrame: Up to 4.6 years in the 303 study
measure: ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period
timeFrame: Up to 5.6 years combining 303 with the initial Study 301; Up to 1 year in the 301 study
measure: Number of Participants With Relapse in the 205MS303 Treatment Period
timeFrame: Up to 4.6 years in the 303 study
measure: Number of Participants With Relapse in the 205MS301-303 Combined Study Period
timeFrame: Up to 5.6 years combining 303 with the initial Study 301
measure: Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period
timeFrame: Up to 4.6 years in Study 303
measure: Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period
timeFrame: Up to 5.6 years combining 303 with the initial Study 301
measure: Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period
timeFrame: Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303
measure: Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period
timeFrame: Baseline 301, Weeks 24, 96, 144 in Study 301
measure: Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period
timeFrame: 301-303: Baseline 303, Weeks 48, 96, 144, 192, 240; 203-303 and 302-303: Week 96
measure: Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period
timeFrame: Baseline 301, Weeks 24, 96 and 144
measure: Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period
timeFrame: Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303
measure: Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period
timeFrame: Baseline 301, Weeks 24, 96, 144 in Study 301
measure: Percent Change in Brain Volume From the 205MS303 Baseline
timeFrame: Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303
measure: Percent Change in Brain Volume From 205MS301 Baseline
timeFrame: Baseline 301, Weeks 48, 96, 144, 192, 240 in Study 303
measure: Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period
timeFrame: Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303; 203-303 and 302-303: Week 96
measure: Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period
timeFrame: Baseline 303, Weeks 12, 24 and 48 in Study 303
measure: Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period
timeFrame: 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
measure: Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period
timeFrame: 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
measure: Number of Participants Who Are Free From Disease Activity in the 205MS303 Treatment Period
timeFrame: Up to 4.6 years in Study 303
measure: Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period
timeFrame: Baseline 303, Weeks 12, 24, 48, 96, 120 and 144
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period
timeFrame: 301-303: Baseline 303, Weeks 24, 48, 96, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48, 96 in 303
measure: Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period
timeFrame: Baseline 301, Weeks 24, 48, 72, 96, 120 and 144 in 301
measure: Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period
timeFrame: Baseline 303, Weeks 12, 24, 48, 72, 96, 120 in Study 303
measure: Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period
timeFrame: 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
measure: HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period
timeFrame: 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
measure: HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period
timeFrame: 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
measure: HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period
timeFrame: 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
measure: HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period
timeFrame: 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
measure: HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period
timeFrame: 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
measure: HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period
timeFrame: 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
measure: HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period
timeFrame: 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
measure: Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period
timeFrame: Up to 4.6 years in 303
measure: Local Tolerability as Assessed by Participant-reported Injection Site Pain VAS
timeFrame: After the first and fourth injections in 303, approximately Week 0 and Week 12
measure: Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories
timeFrame: After the first and fourth injections in 303, approximately Week 0 and Week 12
measure: Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period
timeFrame: Up to 4.6 years in the 303 Treatment Period
measure: Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period
timeFrame: Up to 4.6 years in the 303 Treatment Period
measure: Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period
timeFrame: Baseline 303, Weeks 144, 168, 192, 240 in 303
measure: Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period
timeFrame: Baseline 301, Weeks 24, 48, 72, 96, 120, 144 in 301; Weeks 144, 168, 192, 216, 240 in 303
measure: Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period
timeFrame: Baseline 303, Weeks 12, 24, 48, 120, 144, 168, 192, 216, 240 in 303
measure: Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period
timeFrame: 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
Other outcomes:
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country: Sweden
facility: Research Site
state: Skane
city: Stockholm
country: Sweden
facility: Research Site
state: Sodermanlands Lan
city: Stockholm
country: Sweden
facility: Research Site
state: Sodermanlands Lan
city: Göteborg
country: Sweden
facility: Research Site
state: Vastra Gotalands Lan
city: Stockholm
country: Sweden
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
state: Basel-Stadt (de)
city: Chernivtsi
country: Ukraine
facility: Research Site
state: Chernivets'ka Oblast
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
state: Dnipropetrovs'ka Oblast'
city: Donetsk
country: Ukraine
facility: Research Site
state: Donets'ka Oblast'
city: Kharkiv
country: Ukraine
facility: Research Site
state: Kharkivs'ka Oblast'
city: Kyiv
country: Ukraine
facility: Research Site
state: Kyïv
city: Kyiv
country: Ukraine
facility: Research Site
state: Kyïv
city: Kyiv
country: Ukraine
facility: Research Site
state: Kyïv
city: Odesa
country: Ukraine
facility: Research Site
state: Odes'ka Oblast
city: Poltava
country: Ukraine
facility: Research Site
state: Poltavs'ka Oblast
city: Vinnytsia
country: Ukraine
facility: Research Site
state: Vinnyts'ka Oblast'
city: Zaporizhzhia
country: Ukraine
facility: Research Site
state: Zaporiz'ka Oblast'
city: Zaporizhzhia
country: Ukraine
facility: Research Site
state: Zaporizhia Oblast
city: Kharkiv
country: Ukraine
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
state: Devon
city: Edinburgh
country: United Kingdom
facility: Research Site
state: Edinburgh, City Of
city: Brighton
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.