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Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) 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: October 13, 2014
Last verified: October 2014
  Purpose

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. The secondary objectives are to determine whether Daclizumab High Yield Process is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of relapses and improving quality of life.


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: 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 ]
    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 as the total number of relapses experienced in the group divided by the number of days up to Week 52, and the ratio multiplied by 365.


Secondary Outcome Measures:
  • Number of new Gd-enhancing lesions [ Time Frame: Weeks 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
  • Percentage of participants with relapses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change from Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 physical score [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items.

  • Number of new or newly-enlarging T2 hyperintense lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 626
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: Placebo
Participants will receive 3 subcutaneous (SC) injections of placebo every 4 weeks for up to 52 weeks.
Drug: Placebo
Placebo SC injection
Experimental: 150 mg DAC HYP
Participants will receive 3 SC injections every 4 weeks for up to 52 weeks.
Biological: BIIB019 (Daclizumab High Yield Process)
SC injection
Other Names:
  • DAC HYP
  • BIIB019
  • Daclizumab HYP
Experimental: 300 mg DAC HYP
Participants will receive 3 SC injections every 4 weeks for up to 52 weeks.
Biological: BIIB019 (Daclizumab High Yield Process)
SC injection
Other Names:
  • DAC HYP
  • BIIB019
  • Daclizumab HYP

  Eligibility

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

Key Inclusion Criteria:

  • Multiple Sclerosis (MS) subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline Expanded Disability Status Scale (EDSS) 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 Magnetic resonance imaging (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.

Key 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 within 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.

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: NCT00390221

  Hide Study Locations
Locations
Czech Republic
Research Site
Brno, Czech Republic, 65691
Research Site
Brno, Czech Republic, 62500
Research Site
Olomouc, Czech Republic, 77520
Research Site
Plzen, Czech Republic, 30460
Research Site
Teplice, Czech Republic, 41529
Germany
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, 1115
Research Site
Budapest, Hungary, 1134
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, 93121
Research Site
Katowice, Poland, 40752
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, 12708
Research Site
Moscow, Russian Federation, 115682
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: NCT00390221     History of Changes
Other Study ID Numbers: 205-MS-201
Study First Received: October 17, 2006
Last Updated: October 13, 2014
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
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