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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02881567 |
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Date of registration:
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24/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab
SUSTAIN |
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Scientific title:
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A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN) |
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Date of first enrolment:
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April 18, 2017 |
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Target sample size:
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41 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02881567 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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France
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Germany
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Italy
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Puerto Rico
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United Kingdom
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United States
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Biogen |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria
- Must have documented diagnosis of RRMS (McDonald 2010 Criteria) at screening [Polman
2011].
- Must have been treated with natalizumab for at least the 12 months prior to screening
and have not missed 2 or more consecutive scheduled doses.
- Must be naïve to daclizumab and other forms of daclizumab such as Zenapax® prior to
enrollment.
- Must have a confirmed Expanded Disability Status Scale (EDSS) score of 0 to 5.5,
inclusive, at screening.
- Female participants of childbearing potential must practice effective contraception
from Day -1 and be willing and able to continue contraception for duration of the
study.
Key Exclusion Criteria
- Current participation in another investigational study.
- Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
(as defined by Lublin and Reingold) [Lublin 2014].
- Females breastfeeding, pregnant, or planning to become pregnant; or women who have a
positive pregnancy test result during screening.
- History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior
to screening.
- History of severe hypersensitivity (e.g., anaphylaxis or anaphylactoid reactions) to
the active ingredient or any of the excipients.
- History of severe opportunistic infections (including progressive multifocal
leukoencephalopathy (PML)) or any clinically significant, cardiac, endocrinologic,
hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other
than MS), dermatologic, psychiatric, and renal, or other major disease, as determined
by the Investigator.
- Discontinued natalizumab due to suspicion of PML.
- Known active malignancies (participants with cutaneous basal cell carcinoma that has
been completely excised prior to study entry remain eligible).
- The participant is using another MS therapy concomitantly.
- Known history of human immunodeficiency virus (HIV).
- Positive test result for Hepatitis C virus (test for hepatitis C virus antibody [HCV
Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] and/or
hepatitis B core antibody [HBcAb]).
- The participant has been treated with immunosuppressive or immunomodulating treatments
including mitoxantrone, azathioprine, methotrexate, cyclophosphamide, or mycophenolate
mofetil.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Relapsing-Remitting Multiple Sclerosis (RRMS)
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Intervention(s)
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Drug: Daclizumab
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Primary Outcome(s)
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Percentage of Participants Relapse-free at Month 6
[Time Frame: Month 6]
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Secondary Outcome(s)
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Number of Participants With New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions at Months 6 and 12
[Time Frame: Months 6 and 12]
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
[Time Frame: First dose of study drug to within 30 days of last dose (up to 11 months)]
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Annualized Relapse Rate (ARR) at Month 12
[Time Frame: Month 12]
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Number of Participants With New and Newly Enlarged T2 Hypointense Lesions at Months 6 and 12
[Time Frame: Months 6 and 12]
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Percentage of Participants Experiencing Relapse Requiring Hospitalization and/or Steroid Treatment at Month 12
[Time Frame: Month 12]
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Permanent Discontinuation Rate of Daclizumab at Month 12
[Time Frame: Month 12]
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Percentage of Participants Relapse-free at Month 12
[Time Frame: Month 12]
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Number of Participants With Clinically Relevant Shifts in Laboratory Assessments
[Time Frame: First dose of study drug to within 30 days of last dose (up to 11 months)]
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Secondary ID(s)
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2016-002820-10
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205MS305
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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