A Phase 4, Randomized, Double-Blind Study with a Safety Extension Period to Evaluate the Effect of Aspirin on Flushing Events in Subjects with Relapsing-Remitting Multiple Sclerosis Treated with Tecfidera™ (dimethyl fumarate) delayed-release capsules (ASSURE) - ASSURE

Biogen Idec Research Limited0 个研究点目标入组 240 人开始时间: 2014年3月6日最近更新: 2016年1月18日

适应症

试验速览

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•To be eligible to participate in this study, candidates must meet the following eligibility criteria at the Screening/Baseline Visit or at the time point specified in the individual eligibility criterion listed:
•1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent in accordance with national and local subject privacy regulations.
•2. Age =18 years at the time of informed consent.
•3. Naïve to fumaric acid esters (e.g., DMF, Fumaderm®, compounded fumarates).
•4. Diagnosed with RRMS and satisfies the approved therapeutic indication for DMF.
•5. Subjects of childbearing potential must practice effective contraception and be willing and able to continue contraception during the study through at least the Week 12 Visit. For further details of contraceptive requirements for this study.
•6. Ability to complete the tolerability scales accurately using the eDiary and ability to complete the paper Flushing Diaries.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 220
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Candidates will be excluded from study entry if any of the following exclusion criteria exist at the Screening/Baseline Visit or at the time point specified in the individual criterion listed:
•1. Inability or unwillingness to comply with study requirements or, at the discretion of the Investigator, is deemed unsuitable for study participation.
•2. One or more major comorbidities that, in the opinion of the Investigator, may affect the outcome of the study or otherwise makes the subject an unsuitable candidate for study participation. The prevailing product labels for both DMF and ASA should be used as guides.
•3. Known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
•4. Chronic use (=7 consecutive days) of ASA- or NSAID-containing products within the month prior to enrolment in the study.
•5. A known intolerance to ASA.
•6. Active peptic ulceration or a history of peptic ulceration, hemophilia or other clotting disorders, or gout.
•7. Known hypersensitivity reactions (e.g., bronchospasm, rhinitis, urticaria) in response to ASA or NSAID administration.
•8. Impaired hepatic or renal function, in the opinion of the Investigator.
•9. Female subject is pregnant, lactating, or will be attempting to become pregnant during the Double-Blind Period of the study.
•10. Currently participating in another interventional clinical trial.

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