Trial record 1 of 1 for:    NCT01797965
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Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019 (EXTEND)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT01797965
First received: February 15, 2013
Last updated: June 18, 2015
Last verified: May 2015
  Purpose

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).


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis
Drug: BIIB019 (Daclizumab High Yield Process)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial Study 205MS301 (NCT01064401),Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Annualized Relapse Rate (ARR) [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or 205MS302 ] [ Designated as safety issue: No ]
    Relapses are defined as new or recurrent neurological 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

  • Number of participants who relapse [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or 205MS302 ] [ Designated as safety issue: No ]
  • Number of participants with sustained disability progression [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or 205MS302 ] [ Designated as safety issue: No ]
    Sustained disability progression is defined as at least a 1.0 point increase on the Expanded Disability Status Scale (EDSS) from baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5 point increase on the EDSS from 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. The range of main categories include (0) =normal neurologic exam; to(5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS.

  • Total number of new or newly enlarging T2 hyperintense lesions, gadolinium-enhancing (Gd+) lesions, T1 hypointense lesions, and brain volume change on brain MRI [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or study 205MS302 ] [ Designated as safety issue: No ]
    Assessed by magnetic resonance imaging (MRI)

  • Volume of new or newly enlarging T2 hyperintense lesions, gadolinium-enhancing (Gd+) lesions and T1 hypointense lesions [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or study 205MS302 ] [ Designated as safety issue: No ]
    Assessed by magnetic resonance imaging

  • Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or study 205MS302 ] [ Designated as safety issue: No ]
    MSFC is a three-part, standardized, quantitative, assessment instrument consisting of (Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT); and Paced Auditory Serial Addition Test (PASAT-3" version)

  • Change from baseline in Expanded Disability Status Scale (EDSS) score [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or study 205MS302 ] [ Designated as safety issue: No ]
  • Number of participants who are free from disease activity [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or study 205MS302 ] [ Designated as safety issue: No ]
  • Change from baseline in Multiple Sclerosis Impact Scale 29 (MSIS29) physical and psychological scores [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or study 205MS302 ] [ Designated as safety issue: No ]
    The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items

  • Change in quality of life as assessed by the European Quality of Life, 5 dimensions (EQ 5D and EQ VAS) [ Time Frame: Up to 5 years during the Open-Label Extension Study 205MS303 ] [ Designated as safety issue: No ]
    The EQ-5D is a self-administered questionnaire consisting of 5 sets of 3 questions pertaining to specific health states (i.e.: mobility, self-care, pain, usual activities, anxiety), and a visual analog scale that records the respondent's self-rated health from 0 (worst imaginable health state) to 100 (best imaginable health state).

  • Change from baseline in direct health resource utilization (HRU) [ Time Frame: Up to 5 years during the Open-Label Extension Study 205MS303 ] [ Designated as safety issue: No ]
    Heath resource utilization will be assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits.

  • Change from baseline in treatment satisfaction as assessed by the participants [ Time Frame: Up to 5 years during the Open-Label Extension Study 205MS303 ] [ Designated as safety issue: No ]
  • Change from baseline in participant productivity as assessed by the Health Related Productivity Questionnaire (HRPQ) [ Time Frame: Up to 5 years during the Open-Label Extension Study 205MS303 ] [ Designated as safety issue: No ]
  • Change from baseline in participants with clinically notable laboratory abnormalities [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or 205MS302 ] [ Designated as safety issue: No ]
  • Local tolerability as assessed by subject-reported injection site pain (visual analog scale [VAS]) and clinician injection site assessments [ Time Frame: Up to 5 years during the Open-Label Extension Study 205MS303 ] [ Designated as safety issue: No ]
  • Number of participants with anti-BIIB019 binding antibodies (ADAbs) over time [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or 205MS302 ] [ Designated as safety issue: No ]
  • Number of participants wtih anti-BIIB019 neutralizing antibodies (NAbs) over time [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301, study 205MS203 or 205MS302 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1600
Study Start Date: February 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIIB019
BIIB019 150 mg subcutaneous (SC) every 4 weeks
Drug: BIIB019 (Daclizumab High Yield Process)
Participants will receive open-label treatment with BIIB019 150 mg subcutaneous injection every 4 weeks for up to 5 years.
Other Names:
  • DAC HYP
  • ZINBRYTA

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. The duration of DAC HYP treatment is up to approximately 5 years, or until availability of commercial product (whichever is sooner).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797965

  Show 226 Study Locations
Sponsors and Collaborators
Biogen
AbbVie
Investigators
Study Director: Medical Director Biogen
  More Information

No publications provided

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01797965     History of Changes
Other Study ID Numbers: 205MS303, 2012-003176-39
Study First Received: February 15, 2013
Last Updated: June 18, 2015
Health Authority: Denmark: Danish Medicines Agency
Romania: National Medicines Agency
Brazil: National Health Surveillance Agency
Switzerland: Swissmedic
Ireland: Irish Medicines Board
Mexico: Federal Commission for Protection Against Health Risks
Australia: Department of Health and Ageing Therapeutic Goods Administration
Ukraine: State Expert Centre of the Ministry of Health of Ukraine
Serbia: Medicines and Medical Devices Agency of Serbia
Spain: Spanish Agency of Medicines
Czech Republic: State Institute for Drug Control
Greece: National Organization of Medicines
Sweden: Medical Products Agency
Moldova: Medicines Agency
Hungary: National Institute of Pharmacy
Georgia: Ministry of Health
Canada: Health Canada
France: Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM)
Israel: Ethics Commission
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration
India: Drugs Controller General of India
Finland: National Institute for Health and Welfare
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Germany: Paul-Ehrlich-Institut
Russia: Ministry of Health of the Russian Federation
Italy: The Italian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Daclizumab
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 03, 2015