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
  Purpose

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).


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: Daclizumab HYP
Phase 2

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 Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: March 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Daclizumab HYP
    DAC HYP 150mg SQ every 4 weeks
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051349

  Show 67 Study Locations
Sponsors and Collaborators
Biogen Idec
Abbott Biotherapeutics Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec Inc
ClinicalTrials.gov Identifier: NCT01051349     History of Changes
Other Study ID Numbers: 205-MS-203
Study First Received: January 15, 2010
Last Updated: September 12, 2013
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Biogen Idec:
MS
Multiple Sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Daclizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014