Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Subjects 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:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00870740
First received: March 26, 2009
Last updated: September 12, 2013
Last verified: July 2013

March 26, 2009
September 12, 2013
February 2009
October 2012   (final data collection date for primary outcome measure)
  • Safety as measured by the number of patients with Adverse Events and abnormal Laboratory Evaluations, Vital Signs and Physical Examinations [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: Yes ]
  • Immunogenicity as defined by the incidence of development of antibodies to DAC HYP (Daclizumab high yield process) [ 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 ]
  • The proportion of subjects who are relapse free [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
  • The number of new Gadolinium-enhancing lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
  • The number of new or newly-enlarging T2 hyperintense lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
  • The volume of new T1 hypointense lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
  • The total lesion volume of T2 hyperintense lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
  • The volume of non-Gadolinium-enhancing T1 hypointense lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
  • Total brain volume for assessment of brain atrophy [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
  • 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 Subjects 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 of this study is to assess the durability of the effect of DAC HYP on multiple sclerosis (MS) disease activity.

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 is scheduled to stop at the Week 52 visit. This extension study will provide for the initiation of active therapy with DAC HYP among subjects who received placebo during Weeks 0 through 52 in 205MS201. In addition, in subjects who received active therapy with DAC HYP during Weeks 0 through 52 in 205MS201, in this study will continue DAC HYP therapy or resume DAC HYP therapy after a 6-month washout period.

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
Multiple Sclerosis, Relapsing-Remitting
  • Biological: Daclizumab High Yield Process 150 mg
    Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous (SC) every 4 weeks
    Other Name: DAC HYP
  • Biological: Daclizumab High Yield Process 300 mg
    Daclizumab High Yield Process (DAC HYP) 300mg subcutaneous (SC) every 4 weeks
    Other Name: DAC HYP
  • Experimental: Group 1: DAC HYP 150 mg SC every 4 weeks
    Patients who received placebo in 205MS201(NCT00390221) will receive DAC HYP 150 mg subcutaneous injection every 4 weeks in 205MS202 (NCT00870740)
    Intervention: Biological: Daclizumab High Yield Process 150 mg
  • Experimental: Group 1: DAC HYP 300 mg SC every 4 weeks
    Patients who received placebo in 205MS201 (NCT00390221) will receive DAC HYP 300 mg subcutaneous injection in 205MS202 (NCT00870740)
    Intervention: Biological: Daclizumab High Yield Process 300 mg
  • Experimental: Group 2: Washout followed by DAC HYP 150 mg SC every 4 weeks
    Patients who received DAC HYP 150 mg subcutaneous injection (SC) in 205MS201 (NCT00390221) will undergo a washout period then receive DAC HYP 150 mg SC in 205MS202 (NCT00870740)
    Intervention: Biological: Daclizumab High Yield Process 150 mg
  • Experimental: Group 2: DAC HYP 150 mg SC every 4 weeks
    Patients who received DAC HYP 150 mg subcutaneous injection (SC) in 205MS201 (NCT00390221) will receive DAC HYP 150 mg SC in 205MS202 (NCT00870740)
    Intervention: Biological: Daclizumab High Yield Process 150 mg
  • Experimental: Group 3: Washout followed by DAC HYP 300 mg SC every 4 weeks
    Patients who received DAC HYP 300 mg subcutaneous injection (SC) in 205MS201 (NCT00390221) will undergo a washout period then receive DAC HYP 300 mg SC in 205MS202 (NCT00870740)
    Intervention: Biological: Daclizumab High Yield Process 300 mg
  • Experimental: Group 3: DAC HYP 300 mg SC every 4 weeks
    Patients who received DAC HYP 300 mg subcutaneous injection (SC) in 205MS201 (NCT00390221) will receive DAC HYP 300 mg SC in 205MS202 (NCT00870740)
    Intervention: Biological: Daclizumab High Yield Process 300 mg
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
517
October 2012
October 2012   (final data collection date for primary outcome measure)

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

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 IFN-beta
Both
18 Years to 55 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 MD, Biogen Idec, Inc
Biogen Idec
AbbVie
Not Provided
Biogen Idec
July 2013

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