Safety and Efficacy Study of Daclizumab High Yield Process to Treat Relapsing-Remitting Multiple Sclerosis (SELECT)

This study has been completed.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00390221
First received: October 17, 2006
Last updated: September 12, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine the effect of 2 different doses of daclizumab on reducing relapses in subjects with relapsing-remitting MS.

Primary Objective:

The primary objective of this study is to determine whether Daclizumab High Yield Process, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52.

Secondary Objectives:

The secondary objectives are to determine whether Daclizumab High Yield Process is effective in:

  • reducing the number of new Gd-enhancing lesions over 5 brain MRI scans at Weeks 8, 12, 16, 20, and 24 (calculated as the sum of these 5 MRIs) in a subset of subjects.
  • reducing the number of new or newly-enlarging T2 hyperintense lesions at Week 52,
  • reducing the proportion of relapsing subjects between baseline and Week 52,
  • improving quality of life as measured by the Multiple Sclerosis Impact Scale (MSIS)-29 physical score at Week 52 compared to baseline.

Condition Intervention Phase
Multiple Sclerosis, Relapsing-remitting
Biological: Daclizumab High Yield Process
Other: 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: Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Annualized Relapse Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brain MRI measures (number of gd-enhancing lesions) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of relapsing subjects [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Improving quality of life as measured by Multiple Sclerosis Impact Scale (MSIS)-29 physical score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Brain MRI measures (number of new or newly-enlarging T2 hyperintense lesions) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 621
Study Start Date: February 2008
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
subcutaneous (SC)
Other: placebo
Subcutaneous
Experimental: 2
Daclizumab High Yield Proces (Subcutaneous)
Biological: Daclizumab High Yield Process
150 mg (Subcutaneous) every 4 weeks for 48 weeks
Experimental: 3
Daclizumab High Yield Proces (Subcutaneous)
Biological: Daclizumab High Yield Process
300 mg (Subcutaneous) every 4 weeks for 48 weeks

Detailed Description:

Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. Daclizumab High Yield Process (DAC HYP) is being co-developed by Biogen Idec Inc. (Biogen Idec) and AbbVie for treatment of MS. Daclizumab (DAC) produced using the AbbVie high-yield process is being investigated as an alternative. This study will determine if DAC HYP is safe and efficacious in subjects with relapsing-remitting multiple sclerosis (MS). A dose exploration placebo controlled study will be performed. Proof of profile will be sought that targeting of the alpha chain of the interleukin-2 receptor (IL-2Ralpha) without concomitant interferon (IFN) is effective in subjects with relapsing-remitting MS.

  Eligibility

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

Inclusion Criteria:

  • MS subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline EDSS (Expanded Disability Status Scale) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria

    • Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial MRI demonstrating lesion(s) consistent with MS , OR
    • Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.

Exclusion Criteria:

  • Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
  • History of malignancy
  • History of severe allergic or anaphylactic reactions or known drug hypersensitivity
  • History of abnormal laboratory results
  • History of human immunodeficiency virus (HIV) or other immunodeficient conditions
  • History of drug or alcohol abuse ithin the 2 years prior to randomization
  • An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
  • Positive screening for active infection with Hepatitis B virus or Hepatitis C virus
  • Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening
  • Exposure to varicella zoster virus within 21 days before Screening.
  • Abnormal blood tests at Screening; Hemoglobin ≤9.0 g/dL, Platelets ≤100 × 109/L, Lymphocytes ≤1.0 × 109/L, Neutrophils ≤1.5 × 109/L, alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase >2 times the upper limit of normal (ULN) and serum creatinine >ULN.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390221

  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
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Olomouc, Czech Republic, 77520
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Plzen, Czech Republic, 30460
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Prague, Czech Republic, 10034
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Teplice, Czech Republic, 41529
Germany
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Bayreuth,, Germany, 95445
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Erlangen, Germany, 91054
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Marburg, Germany, 35033
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Osnabrueck, Germany, 49076
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Regensburg, Germany, 93053
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Rostock, Germany, 18147
Hungary
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Budapest, Hungary, 1076
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Budapest, Hungary, 1083
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Budapest, Hungary, 1134
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Budapest, Hungary, 1115
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Budapest, Hungary, 1125
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Debrecen, Hungary, 4043
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Debrecen, Hungary, 4012
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Esztergom, Hungary, 2500
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Gyor, Hungary, 9024
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Kecskemet, Hungary, 6000
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Miskolc, Hungary, 3529
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Miskolc, Hungary, 3526
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Nyiregyhaza, Hungary, 4400
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Siofok, Hungary, 8600
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Zalaegerszeg, Hungary, 8900
India
Research Site
Andra-Pradeash, India, 500082
Research Site
Bangalore, India, 560034
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Kolkata, India, 700068
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Mumbai, India, 400012
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Rajastan, India, 302017
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Vishakhapatnam, India, 530002
Poland
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Bialystok, Poland, 15276
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Bialystok, Poland, 15420
Research Site
Gdansk, Poland, 80803
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
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Lublin, Poland, 20954
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Warsaw, Poland, 2957
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Warszawa, Poland, 2097
Russian Federation
Research Site
Kazan, Russian Federation, 420021
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Krasnoyarsk, Russian Federation, 660022
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Moscow, Russian Federation, 107150
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Moscow, Russian Federation, 115682
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Moscow, Russian Federation, 12708
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Nizhniy Novgorod, Russian Federation, 603076
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Novosibirsk, Russian Federation, 630007
Research Site
Omsk, Russian Federation, 644099
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Samara, Russian Federation, 443099
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Smolensk, Russian Federation, 214019
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St Petersburg, Russian Federation, 194291
Research Site
St Petersburg, Russian Federation, 194044
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Ufa, Russian Federation, 450000
Research Site
Yaroskavi, Russian Federation, 150030
Ukraine
Research Site
Chernivtsy, Ukraine, 58018
Research Site
Dnipropetrovsk, Ukraine, 49027
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Donetsk, Ukraine, 83003
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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
ClinicalTrials.gov Identifier: NCT00390221     History of Changes
Other Study ID Numbers: 205-MS-201
Study First Received: October 17, 2006
Last Updated: September 12, 2013
Health Authority: Ukraine: State Pharmacological Center - Ministry of Health
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
Turkey: Ministry of Health
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
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 April 23, 2014