Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC 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:
NCT01051349
First received: January 15, 2010
Last updated: September 12, 2013
Last verified: August 2012

January 15, 2010
September 12, 2013
March 2010
May 2015   (final data collection date for primary outcome measure)
To assess the safety of extended treatment with DAC HYP monotherapy and the long term immunogenicity of DAC HYP, AEs, laboratory evaluations, vital signs, physical examinations, and immunogenicity (the incidence of development of antibodies to DAC HYP) [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01051349 on ClinicalTrials.gov Archive Site
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: 144 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing Remitting Multiple Sclerosis
A Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)

Extended DAC HYP monotherapy from study 205MS202 in order to evaluate long term safety and efficacy of DAC HYP in subjects with relapsing remitting multiple sclerosis (MS).

This study will provide subjects who complete Study 205MS202 with the option to receive continued open-label DAC HYP monotherapy and to evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP monotherapy in subjects with RRMS.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
Drug: Daclizumab HYP
DAC HYP 150mg SQ every 4 weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
September 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be a subject from Study 205MS202 for at least 52 weeks and must have been compliant with the 205MS202 protocol in the opinion of the Investigator

Exclusion Criteria:

  • Subjects with any significant change in their medical status from the previous study that would prelude administration of DAC HYP as determined by the Investigator
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Hungary,   India,   Poland,   Russian Federation,   Ukraine,   United Kingdom
 
NCT01051349
205-MS-203
Yes
Biogen Idec MD, Biogen Idec Inc
Biogen Idec
Abbott Biotherapeutics Corp.
Not Provided
Biogen Idec
August 2012

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