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 Idec
ClinicalTrials.gov Identifier:
NCT01797965
First received: February 15, 2013
Last updated: February 28, 2014
Last verified: February 2014
  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).

The secondary objectives of this study in this study population are as follows:

  • To assess the long-term immunogenicity of BIIB019
  • To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with BIIB019
  • To assess the safety, tolerability, and efficacy of switching to BIIB019 in participants previously on long-term treatment with interferon β-1a in Study 205MS301 (NCT01064401)
  • To evaluate pharmacodynamic (PD) parameters that may be associated with treatment response

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 Idec:

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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with clinically notable laboratory abnormalities [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301 (NCT01064401) ] [ Designated as safety issue: No ]
  • Number of participants with depression [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301 (NCT01064401) ] [ Designated as safety issue: No ]
    Depression will be assessed by the Beck Depression Inventory, Second Edition (BDI-II ), a self-report rating inventory that measures characteristic attitudes and symptoms of depression

  • 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 (NCT01064401) ] [ 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 (NCT01064401) ] [ Designated as safety issue: No ]
  • Annualized Relapse Rate (ARR) [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301 (NCT01064401) ] [ 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 (NCT01064401) ] [ 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 (NCT01064401) ] [ 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 12 weeks, or at least a 1.5 point increase on the EDSS from 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. 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 (Gd)-enhancing lesions and T1 hypointense lesions [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301 (NCT01064401) ] [ Designated as safety issue: No ]
    Assessed by magnetic resonance imaging (MRI)

  • Volume of new or newly enlarging T2 hyperintense lesions, gadolinium (Gd)-enhancing lesions and T1 hypointense lesions [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301 (NCT01064401) ] [ 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 (NCT01064401) ] [ 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 (NCT01064401) ] [ 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 (NCT01064401) ] [ Designated as safety issue: No ]
  • Number of participants with sustained improvement in disability [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301 (NCT01064401) ] [ Designated as safety issue: No ]
    Sustained improvement in disability is defined as participants with baseline EDSS of at least 2.0 who experience a ≥1.0 decrease in EDSS that is sustained for 24 weeks

  • 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 (NCT01064401) ] [ 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 3 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 3 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 3 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 3 years during the Open-Label Extension Study 205MS303 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1841
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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)
BIIB019 150mg subcutaneous (SC) once every 4 weeks . Note: All participants will receive open-label treatment with BIIB019 for up to 3 years
Other Names:
  • Daclizumab High Yield Process
  • DAC HYP

Detailed Description:

Note: Enrollment will include up to 1841 participants, based on number of participants who completed Study 205MS301 (NCT01064401).

Participants previously treated with BIIB019, 150mg subcutaneous (SC) once every 4 weeks for up to 144 weeks in study 205MS301 (NCT01064401) will continue to receive treatment with BIIB019 in this open-label extension study 205MS303. Participants previously treated with Interferon β1a 30mcg intramuscular (IM) injection once weekly for up to 144 weeks in study 205MS301 (NCT01064401) will transition to receive treatment with BIIB019 150mg subcutaneous (SC) once every 4 weeks in this open-label extension study 205MS303.

  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) 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) prior to the end of the study treatment period, or had an Early Termination visit in Study 205MS301.
  • 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). 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01797965

  Show 215 Study Locations
Sponsors and Collaborators
Biogen Idec
AbbVie
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01797965     History of Changes
Other Study ID Numbers: 205MS303, 2012-003176-39
Study First Received: February 15, 2013
Last Updated: February 28, 2014
Health Authority: Denmark: Danish Medicines Agency
Romania: National Medicines Agency
Brazil: National Health Surveillance Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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
Israel: Ethics Commission
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration
Finland: Finnish Medicines Agency
India: Drugs Controller General of India
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
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Daclizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014