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
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)
2 other identifiers
interventional
517
8 countries
58
Brief Summary
The primary objective of the study was to assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation included the following major components:
- An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in Study 201.
- An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.
- An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP after a 6-month washout period.
- An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during Study 201. 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.
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 2009
Typical duration for phase_2
58 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
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
August 30, 2016
CompletedAugust 30, 2016
July 1, 2016
3.2 years
March 26, 2009
May 31, 2016
July 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of Participants With Treatment-emergent Adverse Events (AEs)
Treatment-emergent AE: any untoward medical occurrence after the first dose of study treatment that did not necessarily have a causal relationship with this treatment. Serious AE (SAE): any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE could also have been a medically significant event that, in the opinion of the Investigator, jeopardized the subject or required intervention to prevent one of the other outcomes listed in the definition above.
Up to 72 weeks
Number of Participants With Abnormalities in Vital Signs
For participants who took DAC HYP during 205MS201 (NCT00390221) the baseline is defined as the baseline from 205MS201, and for participants who took placebo during 205MS201 the baseline is defined as the baseline from 205MS202 (NCT00870740). All post-baseline data are taken after first dose in 205MS202 only. SBP=systolic blood pressure; DBP=diastolic blood pressure; bpm=beats per minute; ↑ BL=increase from baseline; ↓ BL=decrease from baseline.
Up to Week 72
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
Hematology parameters evaluated include: white blood cells, lymphocytes, neutrophils, red blood cells (RBC), hemoglobin, and platelets.
Up to 72 Weeks
Number of Participants With Abnormalities in Blood Chemistry Laboratory Data
For each abnormality a subject can be counted once. If a subject has more than one occurrence of the same abnormality the highest toxicity grade is counted. ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; GGT=gamma-glutamyl transferase; TSH=thyroid stimulating hormone, ULN=upper limit of normal.
Up to 72 Weeks
Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline
Number of participants positive and negative for ADAb and NAb, based on all post-baseline immunogenicity assessments during treatment period and follow-up. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.
Up to 72 weeks
Secondary Outcomes (8)
Adjusted Annualized Relapse Rate
Up to 72 weeks
Estimated Proportion of Participants With a Relapse
Up to 72 weeks
Mean Number of New Gadolinium-enhancing Lesions
Week 20, Week 52
Mean Number of New or Newly-enlarging T2 Hyperintense Lesions
Baseline, Week 20, Week 52
Mean Volume of New T1 Hypointense Lesions
Baseline, Week 20, Week 52
- +3 more secondary outcomes
Study Arms (6)
Group 1: DAC HYP 150 mg
EXPERIMENTALParticipants who received placebo in 205MS201 receive DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
Group 1: DAC HYP 300 mg
EXPERIMENTALParticipants who received placebo in 205MS201 receive DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
Group 2: Washout then DAC HYP 150 mg
EXPERIMENTALParticipants who received DAC HYP 150 mg SC injection in 205MS201 undergo a washout period (placebo SC every 4 weeks for a total of 5 doses) and then receive DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
Group 2: DAC HYP 150 mg
EXPERIMENTALParticipants who received DAC HYP 150 mg SC injection in 205MS201 receive DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
Group 3: Washout then DAC HYP 300 mg
EXPERIMENTALParticipants who received DAC HYP 300 mg SC in 205MS201 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.
Group 3: DAC HYP 300 mg
EXPERIMENTALParticipants who received DAC HYP 300 mg SC in 205MS201 receive DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
Interventions
SC injection
Placebo SC injection
Eligibility Criteria
You may qualify if:
- Participated in Study 205MS201 (NCT00390221) for at least 52 weeks and was compliant with the 205MS201 protocol in the opinion of the Investigator.
You may not qualify if:
- Subjects with any significant change in their medical status from 205MS201 that would preclude administration of DAC HYP, as determined by the Investigator
- Any subject who has permanently discontinued study treatment in Study 205MS201 except subjects who were unblinded during evaluation of an adverse event (AE) and found to be on placebo
- Planned ongoing treatment with any approved or experimental treatment for MS except for the protocol-allowed use of concomitant interferon-beta
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Research Site
Brno, Czechia
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Hraddec Kralove, Czechia
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Olomouc, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Teplice, Czechia
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Bayreuth, Germany
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Erlangen, Germany
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Marburg, Germany
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OsnabrĂ¼ck, 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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NyĂregyhĂ¡za, Hungary
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SiĂ³fok, Hungary
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Zalaegerszeg, Hungary
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Andra-Pradeash, India
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Bangalore, India
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Jaipur, India
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Kolkata, India
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Mumbai, 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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Yaroskavl, 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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Devon, United Kingdom
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London, United Kingdom
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Nottingham, United Kingdom
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Sheffield, United Kingdom
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Stoke-on-Trent, United Kingdom
Related Publications (2)
Gold R, Stefoski D, Selmaj K, Havrdova E, Hurst C, Holman J, Tornesi B, Akella S, McCroskery P. Pregnancy Experience: Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program. Neurol Ther. 2016 Dec;5(2):169-182. doi: 10.1007/s40120-016-0048-2. Epub 2016 Jul 13.
PMID: 27411694DERIVEDGiovannoni G, Gold R, Selmaj K, Havrdova E, Montalban X, Radue EW, Stefoski D, McNeill M, Amaravadi L, Sweetser M, Elkins J, O'Neill G; SELECTION Study Investigators. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECTION): a multicentre, randomised, double-blind extension trial. Lancet Neurol. 2014 May;13(5):472-81. doi: 10.1016/S1474-4422(14)70039-0. Epub 2014 Mar 19.
PMID: 24656609DERIVED
Related Links
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
March 26, 2009
First Posted
March 27, 2009
Study Start
February 1, 2009
Primary Completion
May 1, 2012
Study Completion
October 1, 2012
Last Updated
August 30, 2016
Results First Posted
August 30, 2016
Record last verified: 2016-07