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Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis. (SELECTION)

This study has been completed.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00870740
First received: March 26, 2009
Last updated: October 13, 2014
Last verified: October 2014

March 26, 2009
October 13, 2014
February 2009
May 2012   (final data collection date for primary outcome measure)
  • Number of participants with Adverse Events and abnormal Laboratory Evaluations, Vital Signs and Physical Examinations [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with development of antibodies to DAC HYP [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: Yes ]
To assess the safety and immunogenicity of extended treatment with DAC HYP (adverse events, laboratory evaluations, vital signs, physical examinations, and immunogenicity as defined by the incidence of development of antibodies to DAC HYP). [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00870740 on ClinicalTrials.gov Archive Site
  • Annualized relapse rate [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Relapses are defined as new or recurrent neurologic 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. The annualized relapse rate will be calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.
  • The percentage of participants who are relapse free [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Relapses are defined as new or recurrent neurologic 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.
  • The number of new Gadolinium-enhancing lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.
  • The number of new or newly-enlarging T2 hyperintense lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.
  • The volume of new T1 hypointense lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.
  • The total lesion volume of T2 hyperintense lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.
  • The volume of non-Gadolinium-enhancing T1 hypointense lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.
  • Total brain volume [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    To assess brain atrophy, total brain volume will be measured by magnetic resonance imaging (MRI) and analyzed by a central reader.
  • The durability of DAC HYP measured by brain MRI (new Gd-enhancing lesions; new or newly-enlarging T2 hyperintense lesions; vol of new T1 hypointense lesions; total lesion vol of T2 hyperintense lesions; vol of non-Gd-enhancing T1 hypointense lesions [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • The durability of the effect of DAC HYP on MS disease activity as measured by clinical MS relapses (the number of relapses based on the annualized relapse rate; and the proportion of subjects who are relapse free). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis.
A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT)

The primary objectives of this study are to assess the safety and immunogenicity of extended treatment with Daclizumab High Yield Process (DAC HYP). The secondary objective is to assess the durability of the effect of DAC HYP on multiple sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.

This study is an extension to the Daclizumab High Yield Process (DAC HYP) therapy from Study 205MS201 (NCT00390221) to evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP in multiple sclerosis (MS). In Study 205MS201, study treatment was scheduled to stop at the Week 52 visit. This extension study will provide for the initiation of active therapy with DAC HYP among participants who received placebo during Weeks 0 through 52 in 205MS201. In addition, participants who received active therapy with DAC HYP during Weeks 0 through 52 in 205MS201, will continue DAC HYP therapy or resume DAC HYP therapy after a 6-month washout period in this study.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing-Remitting Multiple Sclerosis
  • Biological: BIIB019 (Daclizumab High Yield Process)
    Daclizumab High Yield Process (DAC HYP) subcutaneous (SC) injection
    Other Names:
    • BIIB019 (Daclizumab High Yield Process)
    • DAC HYP
  • Drug: Placebo
    Placebo SC injection
  • Experimental: Group 1: DAC HYP 150 mg
    Participants who received placebo in 205MS201 will receive DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
    Intervention: Biological: BIIB019 (Daclizumab High Yield Process)
  • Experimental: Group 1: DAC HYP 300 mg
    Participants who received placebo in 205MS201 will receive DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
    Intervention: Biological: BIIB019 (Daclizumab High Yield Process)
  • Experimental: Group 2: Washout then DAC HYP 150 mg
    Participants who received DAC HYP 150 mg SC injection in 205MS201 will undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and will then receive DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
    Interventions:
    • Biological: BIIB019 (Daclizumab High Yield Process)
    • Drug: Placebo
  • Experimental: Group 2: DAC HYP 150 mg
    Participants who received DAC HYP 150 mg SC injection in 205MS201 will receive DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
    Intervention: Biological: BIIB019 (Daclizumab High Yield Process)
  • Experimental: Group 3: Washout then DAC HYP 300 mg
    Participants who received DAC HYP 300 mg SC in 205MS201 will undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
    Interventions:
    • Biological: BIIB019 (Daclizumab High Yield Process)
    • Drug: Placebo
  • Experimental: Group 3: DAC HYP 300 mg
    Participants who received DAC HYP 300 mg SC in 205MS201 will receive DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
    Intervention: Biological: BIIB019 (Daclizumab High Yield Process)
Giovannoni G, Gold R, Selmaj K, Havrdova E, Montalban X, Radue EW, Stefoski D, McNeill M, Amaravadi L, Sweetser M, Elkins J, O'Neill G; SELECTION Study Investigators. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): a multicentre, randomised, double-blind extension trial. Lancet Neurol. 2014 May;13(5):472-81. doi: 10.1016/S1474-4422(14)70039-0. Epub 2014 Mar 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
520
October 2013
May 2012   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Must be a subject from Study 205MS201 (NCT00390221) for at least 52 weeks and must have been compliant with the 205MS201 protocol in the opinion of the Investigator.

Key Exclusion Criteria:

  • Subjects with any significant change in their medical status from 205MS201 (NCT00390221) that would preclude administration of Daclizumab High Yield Process (DAC HYP), as determined by the Investigator
  • Any subject who has permanently discontinued study treatment in Study 205MS201 (NCT00390221) except subjects who were unblinded during evaluation of an adverse event (AE)
  • Planned ongoing treatment with any approved or experimental treatment for multiple sclerosis (MS) except for the protocol-allowed use of concomitant interferon (IFN)-beta NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Both
18 Years to 56 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Hungary,   India,   Poland,   Russian Federation,   Ukraine,   United Kingdom
 
NCT00870740
205-MS-202, EUDRA CT No.: 2008-005559-46
Yes
Biogen Idec
Biogen Idec
AbbVie
Study Director: Medical Director Biogen Idec
Biogen Idec
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP