Long-Term Extension Study in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of DAC HYP - Full Text View

Purpose

The primary objective of the study is to assess the safety and tolerability of long-term treatment with DAC HYP monotherapy in subjects with 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 DAC HYP
To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and patient-reported impact of MS, following long-term treatment with DAC HYP
To assess the safety, tolerability, and efficacy of switching to DAC HYP in subjects 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
Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis	Drug: DAC HYP	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:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Daclizumab

U.S. FDA Resources

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 ]
Incidence of depression as assessed by the Beck Depression Inventory, Second Edition (BDI-II ) [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301 (NCT01064401) ] [ Designated as safety issue: No ]
Incidence of anti-DAC HYP 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 ]
Incidence of anti-DAC HYP 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 ]
Number of subjects 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 ]
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 ]
Magnetic resonance imaging (MRI) outcomes as measured by total number of new or newly enlarging T2 hyperintense lesions, gadolinium (Gd)-enhancing lesions, T1 hypointense lesions, and brain atrophy on brain MRI [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301 (NCT01064401) ] [ Designated as safety issue: No ]
Magnetic resonance imaging (MRI) outcomes as measured by volume of new or newly enlarging T2 hyperintense lesions, gadolinium (Gd)-enhancing lesions, T1 hypointense lesions, and brain atrophy on brain MRI [ Time Frame: Up to 6 years combining the Open-Label Extension Study 205MS303 with the initial study 205MS301 (NCT01064401) ] [ Designated as safety issue: No ]
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 ]
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 subjects 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 subjects 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 ]
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 ]
Change from baseline 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 ]
Change from baseline in direct health resource utilization (HRU; hospitalizations, emergency room visits, and unscheduled neurologist visits) [ Time Frame: Up to 3 years during the Open-Label Extension Study 205MS303 ] [ Designated as safety issue: No ]
Change from baseline in treatment satisfaction as assessed by the subject [ Time Frame: Up to 3 years during the Open-Label Extension Study 205MS303 ] [ Designated as safety issue: No ]
Change from baseline in subject 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: DAC HYP / DAC HYP Patients previously treated with DAC HYP 150mg subcutaneous (SC) once every 4 weeks for up to 144 weeks in study 205MS301 (NCT01064401). Patients will continue to receive treatment with DAC HYP in this open-label extension study 205MS303.	Drug: DAC HYP DAC HYP 150mg subcutaneous (SC) once every 4 weeks . Note: All subjects will receive open-label treatment with DAC HYP for up to 3 years Other Name: Daclizumab High Yield
Experimental: Interferonβ1a / DAC HYP Patients previously treated with Interferon β1a 30mcg intramuscular (IM) injection once weekly for up to 144 weeks in study 205MS301 (NCT01064401). Patients will transition to receive treatment with DAC HYP 150mg subcutaneous (SC) once every 4 weeks in this open-label extension study 205MS303.	Drug: DAC HYP DAC HYP 150mg subcutaneous (SC) once every 4 weeks . Note: All subjects will receive open-label treatment with DAC HYP for up to 3 years Other Name: Daclizumab High Yield

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

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 DAC HYP, 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.

Contacts and Locations

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

Locations

United States, Massachusetts
Research Site
Cambridge, Massachusetts, United States

Sponsors and Collaborators

Biogen Idec

AbbVie

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 21, 2013
Health Authority:	United States: Food and Drug Administration

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 May 19, 2013

Long-Term Extension Study in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of DAC HYP (EXTEND)