Safety and Efficacy Extension Study of Daclizumab HYP to Treat Relapsing-Remitting Multiple Sclerosis

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Abbott Biotherapeutics Corp.

Information provided by:

Biogen Idec

ClinicalTrials.gov Identifier:

NCT00870740

First received: March 26, 2009

Last updated: August 9, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 26, 2009
Last Updated Date	August 9, 2012
Start Date ^ICMJE	February 2009
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 26, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00870740 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 26, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Extension Study of Daclizumab HYP to Treat Relapsing-Remitting Multiple Sclerosis
Official Title ^ICMJE	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)
Brief Summary	Extend DAC HYP therapy from Study 205MS201 in order to evaluate long term safety and efficacy of DAC HYP in subjects with relapsing-remitting MS.
Detailed Description	This study is an extension to the DAC HYP therapy from Study 205MS201 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, this study will continue DAC HYP therapy or resume DAC HYP therapy after a 6-month washout period.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Multiple Sclerosis, Relapsing-Remitting
Intervention ^ICMJE	Drug: Daclizumab HYP DAC HYP 150mg SQ every 4 weeks Drug: Daclizumab HYP DAC HYP 300mg SQ every 4 weeks
Study Arm (s)	Experimental: 1 Drug washout / DAC HYP 150 mg SQ every 4 weeks Intervention: Drug: Daclizumab HYP Experimental: 2 DAC HYP 150 mg SQ every 4 weeks Intervention: Drug: Daclizumab HYP Experimental: 3 Drug washout / DAC HYP 300 mg SQ every 4 weeks Intervention: Drug: Daclizumab HYP Experimental: 4 DAC HYP 300 mg SQ every 4 weeks Intervention: Drug: Daclizumab HYP
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	600
Estimated Completion Date	December 2012
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Must be a subject from Study 205MS201 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 the previous study that would preclude administration of DAC HYP, as determined by the Investigator
Gender	Both
Ages	18 Years to 56 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Czech Republic, Germany, Hungary, India, Poland, Russian Federation, Ukraine, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00870740
Other Study ID Numbers ^ICMJE	205-MS-202
Has Data Monitoring Committee	Yes
Responsible Party	Biogen Idec MD, Biogen Idec, Inc
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Abbott Biotherapeutics Corp.
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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