Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis
Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis
The primary objective of the study is to evaluate whether 150 mg enteric-coated aspirin
 (acetylsalicylic acid [ASA]) taken twice a day (BID) with dimethyl fumarate (DMF)
 administration or 75 mg enteric-coated ASA taken once daily in the morning (QAM) with DMF
 administration reduces the incidence and/or severity of flushing events in subjects with
 relapsing-remitting multiple sclerosis (RRMS) compared with ASA-placebo administered with DMF
 in the clinical practice setting.

 Secondary objectives of this study are: to evaluate the safety and tolerability of DMF
 administered with and without enteric-coated ASA in the clinical practice setting; to
 evaluate the impact of DMF administration on quality of life as measured by the Short Form 36
 (SF-36®) and European Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L) questionnaires.
Key Inclusion Criteria:

 -  Naïve to fumaric acid esters (e.g. DMF, Fumaderm, compounded fumarates)

 -  Diagnosed with RRMS and satisfies the approved therapeutic indication for DMF

 -  Participants of childbearing potential must practice effective contraception and be
 willing and able to continue contraception throughout the study

 -  Ability to complete the tolerability scales accurately using the electronic diary
 (eDiary) and ability to complete the paper Flushing Diaries

 Key Exclusion Criteria:

 -  Inability or unwillingness to comply with study requirements or, at the discretion of
 the Investigator, is deemed unsuitable for study participation

 -  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

 -  Known active malignancies (subjects with cutaneous basal cell carcinoma that has been
 completely excised prior to study entry remain eligible)

 -  Chronic use (≥7 consecutive days) of ASA- or nonsteroidal anti-inflammatory drugs
 (NSAID)-containing products within the month prior to enrollment in the study

 -  A known intolerance to ASA

 -  Active peptic ulceration or a history of peptic ulceration, hemophilia or other
 clotting disorders, or gout

 -  Known hypersensitivity reactions (e.g., bronchospasm, rhinitis, urticaria) in response
 to ASA or NSAID administration

 -  Impaired hepatic or renal function, in the opinion of the investigator

 -  Female subject is pregnant, lactating, or will be attempting to become pregnant during
 the Double-Blind Period (first 12 weeks) of the study

 -  Currently participating in another interventional clinical trial

 NOTE: Other protocol-defined inclusion/exclusion criteria may apply