Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab
NCT ID: NCT02881567
Last Updated: 2019-09-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
41 participants
INTERVENTIONAL
2017-04-18
2018-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Daclizumab
Daclizumab
High yield formulation
Interventions
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Daclizumab
High yield formulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Tampa, Florida, United States
Research Site
Des Moines, Iowa, United States
Research Site
Milwaukee, Wisconsin, United States
Research Site
Edmonton, Alberta, Canada
Research Site
Munich, Bavaria, Germany
Research Site
Potsdam, Brandenburg, Germany
Research Site
Dresden, Saxony, Germany
Research Site
Hamburg, , Germany
Research Site
Pozzilli, Isernia, Italy
Research Site
Napoli, , Italy
Research Site
Guaynabo, , Puerto Rico
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2016-002820-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
205MS305
Identifier Type: -
Identifier Source: org_study_id
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