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

  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, 1076
Research Site
Budapest, Hungary, 1083
Research Site
Budapest, Hungary, 1134
Research Site
Budapest, Hungary, 1115
Research Site
Budapest, Hungary, 1125
Research Site
Debrecen, Hungary, 4043
Research Site
Debrecen, Hungary, 4012
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, 40752
Research Site
Katowice, Poland, 93121
Research Site
Katowice, Poland, 40753
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, 2125
Research Site
Kiev, Ukraine, 3110
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
  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:
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
Immunoglobulin G
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014