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
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Biological: Daclizumab High Yield Process 150 mg
Biological: Daclizumab High Yield Process 300 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 517
Study Start Date: February 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Biological: Daclizumab High Yield Process 150 mg
Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous (SC) every 4 weeks
Other Name: DAC HYP
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)
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 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)
Biological: Daclizumab High Yield Process 150 mg
Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous (SC) every 4 weeks
Other Name: DAC HYP
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)
Biological: Daclizumab High Yield Process 150 mg
Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous (SC) every 4 weeks
Other Name: DAC HYP
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)
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 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)
Biological: Daclizumab High Yield Process 300 mg
Daclizumab High Yield Process (DAC HYP) 300mg subcutaneous (SC) every 4 weeks
Other Name: DAC HYP

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00870740

  Show 80 Study Locations
Sponsors and Collaborators
Biogen Idec
AbbVie
  More Information

Additional Information:
No publications provided by Biogen Idec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen Idec MD, Biogen Idec, Inc
ClinicalTrials.gov Identifier: NCT00870740     History of Changes
Other Study ID Numbers: 205-MS-202, EUDRA CT No.: 2008-005559-46
Study First Received: March 26, 2009
Last Updated: September 12, 2013
Health Authority: Ukraine: State Expert Centre of the Ministry of Health of Ukraine
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Russia: Ministry of Health of the Russian Federation
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
India: Drugs Controller General of India
Germany: Paul-Ehrlich-Institut

Keywords provided by Biogen Idec:
MS
Multiple Sclerosis

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

ClinicalTrials.gov processed this record on July 23, 2014