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Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants 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 (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00870740
First received: March 26, 2009
Last updated: October 13, 2014
Last verified: October 2014
  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 is to assess the durability of the effect of DAC HYP on multiple sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Biological: BIIB019 (Daclizumab High Yield Process)
Drug: Placebo
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:
  • Number of participants with Adverse Events and abnormal Laboratory Evaluations, Vital Signs and Physical Examinations [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with development of antibodies to DAC HYP [ 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 ]
    Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The annualized relapse rate will be calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.

  • The percentage of participants who are relapse free [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.

  • The number of new Gadolinium-enhancing lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.

  • The number of new or newly-enlarging T2 hyperintense lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.

  • The volume of new T1 hypointense lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.

  • The total lesion volume of T2 hyperintense lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.

  • The volume of non-Gadolinium-enhancing T1 hypointense lesions [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.

  • Total brain volume [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    To assess brain atrophy, total brain volume will be measured by magnetic resonance imaging (MRI) and analyzed by a central reader.


Enrollment: 520
Study Start Date: February 2009
Study Completion Date: October 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: DAC HYP 150 mg
Participants who received placebo in 205MS201 will receive DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Biological: BIIB019 (Daclizumab High Yield Process)
Daclizumab High Yield Process (DAC HYP) subcutaneous (SC) injection
Other Names:
  • BIIB019 (Daclizumab High Yield Process)
  • DAC HYP
Experimental: Group 1: DAC HYP 300 mg
Participants who received placebo in 205MS201 will receive DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
Biological: BIIB019 (Daclizumab High Yield Process)
Daclizumab High Yield Process (DAC HYP) subcutaneous (SC) injection
Other Names:
  • BIIB019 (Daclizumab High Yield Process)
  • DAC HYP
Experimental: Group 2: Washout then DAC HYP 150 mg
Participants who received DAC HYP 150 mg SC injection in 205MS201 will undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and will then receive DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
Biological: BIIB019 (Daclizumab High Yield Process)
Daclizumab High Yield Process (DAC HYP) subcutaneous (SC) injection
Other Names:
  • BIIB019 (Daclizumab High Yield Process)
  • DAC HYP
Drug: Placebo
Placebo SC injection
Experimental: Group 2: DAC HYP 150 mg
Participants who received DAC HYP 150 mg SC injection in 205MS201 will receive DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
Biological: BIIB019 (Daclizumab High Yield Process)
Daclizumab High Yield Process (DAC HYP) subcutaneous (SC) injection
Other Names:
  • BIIB019 (Daclizumab High Yield Process)
  • DAC HYP
Experimental: Group 3: Washout then DAC HYP 300 mg
Participants who received DAC HYP 300 mg SC in 205MS201 will undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
Biological: BIIB019 (Daclizumab High Yield Process)
Daclizumab High Yield Process (DAC HYP) subcutaneous (SC) injection
Other Names:
  • BIIB019 (Daclizumab High Yield Process)
  • DAC HYP
Drug: Placebo
Placebo SC injection
Experimental: Group 3: DAC HYP 300 mg
Participants who received DAC HYP 300 mg SC in 205MS201 will receive DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Biological: BIIB019 (Daclizumab High Yield Process)
Daclizumab High Yield Process (DAC HYP) subcutaneous (SC) injection
Other Names:
  • BIIB019 (Daclizumab High Yield Process)
  • 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 was scheduled to stop at the Week 52 visit. This extension study will provide for the initiation of active therapy with DAC HYP among participants who received placebo during Weeks 0 through 52 in 205MS201. In addition, participants who received active therapy with DAC HYP during Weeks 0 through 52 in 205MS201, will continue DAC HYP therapy or resume DAC HYP therapy after a 6-month washout period in this study.

  Eligibility

Ages Eligible for Study:   18 Years to 56 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key 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.

Key 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 interferon (IFN)-beta NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
  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

  Hide Study Locations
Locations
Czech Republic
Research Site
Brno, Czech Republic, 65691
Research Site
Brno, Czech Republic, 62500
Research Site
Hradec Kralove, Czech Republic, 50005
Research Site
Olomouc, Czech Republic, 77520
Research Site
Plzen, Czech Republic, 30460
Research Site
Prague, Czech Republic, 10034
Research Site
Teplice, Czech Republic, 41529
Germany
Research Site
Bayreuth,, Germany, 95445
Research Site
Berlin, Germany, 13347
Research Site
Erlangen, Germany, 91054
Research Site
Marburg, Germany, 35033
Research Site
Osnabrueck, Germany, 49076
Research Site
Regensburg, Germany, 93053
Research Site
Rostock, Germany, 18147
Hungary
Research Site
Budapest, Hungary, 1083
Research Site
Budapest, Hungary, 1134
Research Site
Budapest, Hungary, 1115
Research Site
Budapest, Hungary, 1125
Research Site
Budapest, Hungary, 1076
Research Site
Debrecen, Hungary, 4012
Research Site
Debrecen, Hungary, 4043
Research Site
Esztergom, Hungary, 2500
Research Site
Gyor, Hungary, 9024
Research Site
Kecskemet, Hungary, 6000
Research Site
Miskolc, Hungary, 3529
Research Site
Miskolc, Hungary, 3526
Research Site
Nyiregyhaza, Hungary, 4400
Research Site
Siofok, Hungary, 8600
Research Site
Zalaegerszeg, Hungary, 8900
India
Research Site
Andra-Pradeash, India, 500082
Research Site
Bangalore, India, 560034
Research Site
Chennai, India, 600026
Research Site
Kolkata, India, 700068
Research Site
Mumbai, India, 400012
Research Site
Pune, India, 411001
Research Site
Rajastan, India, 302017
Research Site
Vishakhapatnam, India, 530002
Poland
Research Site
Bialystok, Poland, 15276
Research Site
Bialystok, Poland, 15420
Research Site
Gdansk, Poland, 80803
Research Site
Katowice, Poland, 40753
Research Site
Katowice, Poland, 93121
Research Site
Katowice, Poland, 40752
Research Site
Krakow, Poland, 31530
Coordinating Research Site
Lodz, Poland, 90153
Research Site
Lodz, Poland, 93121
Research Site
Lublin, Poland, 20954
Research Site
Warsaw, Poland, 2957
Research Site
Warszawa, Poland, 2097
Russian Federation
Research Site
Kazan, Russian Federation, 420021
Research Site
Krasnoyarsk, Russian Federation, 660022
Research Site
Moscow, Russian Federation, 107150
Research Site
Moscow, Russian Federation, 115682
Research Site
Moscow, Russian Federation, 12708
Research Site
Nizhniy Novgorod, Russian Federation, 603076
Research Site
Novosibirsk, Russian Federation, 630007
Research Site
Omsk, Russian Federation, 644099
Research Site
Samara, Russian Federation, 443099
Research Site
Smolensk, Russian Federation, 214019
Research Site
St Petersburg, Russian Federation, 194291
Research Site
St Petersburg, Russian Federation, 194044
Research Site
Ufa, Russian Federation, 450000
Research Site
Yaroskavi, Russian Federation, 150030
Ukraine
Research Site
Chernivtsy, Ukraine, 58018
Research Site
Dnipropetrovsk, Ukraine, 49027
Research Site
Donetsk, Ukraine, 83003
Research Site
Kharkiv, Ukraine, 61068
Research Site
Kharkiv, Ukraine
Research Site
Kiev, Ukraine, 3110
Research Site
Kiev, Ukraine, 2125
Research Site
Kyiv, Ukraine, 3110
Research Site
Lviv, Ukraine, 79010
Research Site
Poltava, Ukraine, 360011
Research Site
Zaporozhye, Ukraine, 69600
Research Site
Zaporozhye, Ukraine, 69035
United Kingdom
Research Site
London, United Kingdom, SE59RF
Research Site
Nottingham, United Kingdom, NG72UH
Research Site
Plymouth, United Kingdom, PL68DH
Research Site
Sheffield, United Kingdom, S102JF
Research Site
Stoke-on-Trent, United Kingdom, ST47LN
Sponsors and Collaborators
Biogen Idec
AbbVie
Investigators
Study Director: Medical Director Biogen Idec
  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
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: October 13, 2014
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
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
Russia: Ministry of Health of the Russian Federation

Keywords provided by Biogen Idec:
MS
Multiple Sclerosis

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

ClinicalTrials.gov processed this record on November 25, 2014