Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis
SELECT
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
1 other identifier
interventional
621
8 countries
56
Brief Summary
The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP 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 participants with relapses, and improving quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2008
Typical duration for phase_2
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2006
CompletedFirst Posted
Study publicly available on registry
October 19, 2006
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
July 11, 2016
CompletedJuly 11, 2016
May 1, 2016
3.2 years
October 17, 2006
May 31, 2016
May 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adjusted Annualized Relapse Rate Between Baseline and Week 52
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 was calculated as the total number of relapses that occurred during the study divided by the total number of subject-years followed in the study.
Baseline through Week 52
Secondary Outcomes (4)
Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24
Week 8 through Week 24
Adjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52
Week 52
Proportion of Participants Who Relapsed at Week 52
Week 52
Mean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52
Baseline and Week 52
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants will receive 3 subcutaneous (SC) injections of placebo every 4 weeks for up to 52 weeks.
150 mg DAC HYP
EXPERIMENTALParticipants will receive 3 SC injections every 4 weeks for up to 52 weeks.
300 mg DAC HYP
EXPERIMENTALParticipants will receive 3 SC injections every 4 weeks for up to 52 weeks.
Interventions
SC injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 based on investigator judgment
- 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 × 10\^9/L, Lymphocytes ≤1.0 × 10\^9/L, Neutrophils ≤1.5 × 10\^9/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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Research Site
Brno, Czechia
Research Site
Olomouc, Czechia
Research Site
Pilsen, Czechia
Research Site
Teplice, Czechia
Research Site
Erlangen, Germany
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Marburg, Germany
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Osnabrück, Germany
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Regensburg, Germany
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Rostock, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Esztergom, Hungary
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Győr, Hungary
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Kecskemét, Hungary
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Miskolc, Hungary
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Nyíregyháza, Hungary
Research Site
Siófok, Hungary
Research Site
Zalaegerszeg, Hungary
Research Site
Andra-Pradeash, India
Research Site
Bangalore, India
Research Site
Chennai, India
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Kolkata, India
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Mumbai, India
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Rajasthan, India
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Visakhapatnam, India
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Bialystok, Poland
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Gdansk, Poland
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Warsaw, Poland
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Kazan', Russia
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Krasnoyarsk, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Novosibirsk, Russia
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Omsk, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Smolensk, Russia
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Ufa, Russia
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Yaroslavl, Russia
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Chernivtsi, Ukraine
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Lviv, Ukraine
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Poltava, Ukraine
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Zaporizhzhya, Ukraine
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London, United Kingdom
Research Site
Nottingham, United Kingdom
Research Site
Plymouth, United Kingdom
Research Site
Sheffield, United Kingdom
Research Site
Stoke-on-Trent, United Kingdom
Related Publications (2)
Huss DJ, Mehta DS, Sharma A, You X, Riester KA, Sheridan JP, Amaravadi LS, Elkins JS, Fontenot JD. In vivo maintenance of human regulatory T cells during CD25 blockade. J Immunol. 2015 Jan 1;194(1):84-92. doi: 10.4049/jimmunol.1402140.
PMID: 25416807DERIVEDGold R, Giovannoni G, Selmaj K, Havrdova E, Montalban X, Radue EW, Stefoski D, Robinson R, Riester K, Rana J, Elkins J, O'Neill G; SELECT study investigators. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Jun 22;381(9884):2167-75. doi: 10.1016/S0140-6736(12)62190-4. Epub 2013 Apr 4.
PMID: 23562009DERIVED
Related Links
- (MSActiveSource.com is a resource for news, information, and disease management for all individuals touched by Multiple Sclerosis. This site is sponsored by Biogen Idec.)
- (The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families, and healthcare providers.)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Study Medical Director
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2006
First Posted
October 19, 2006
Study Start
February 1, 2008
Primary Completion
May 1, 2011
Study Completion
August 1, 2011
Last Updated
July 11, 2016
Results First Posted
July 11, 2016
Record last verified: 2016-05