Treatment Adherence When Using RebiSmart™ in Relapsing Multiple Sclerosis Subjects

Launched by MERCK KGAA, DARMSTADT, GERMANY · May 20, 2010

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males and females between 18 and 65 years of age.
• • Have RMS according to the revised McDonald Criteria.
• • Subject is eligible for Rebif® therapy according to indications and clinical use in the Rebif® Product Monograph.
• • Be willing and able to comply with the protocol requirements for the duration of the study.
• • Have given written informed consent prior to entering the screening period.
• • Must register with the Rebif® Multiple Support Program.
• • Subjects previously on disease modifying drugs (DMDs) must be stable and not be experiencing any side effects related to the previous DMDs at the time of enrollment into the study, in the opinion of the investigator. Rebif® will be prescribed as per Product Monograph and a washout period will be left at the discretion of the investigator.
• Exclusion Criteria:
• • Have any disease other than MS that could better explain his/her signs and symptoms.
• • Receive any other injectable medications on a regular basis during the week prior to the screening period or throughout the duration of the study. The administration of a single injection for treatment or prophylaxis of a condition unrelated to the subject's MS (e.g.,influenza or pneumococcus vaccination) will be acceptable.
• • Are contraindicated for the use of Rebif® according to the Rebif® Product Monograph.
• • Have a diagnosis of clinically isolated syndrome (CIS).
• • Participation in any other investigational trial prior to 30 days of Study Day 1.
• • Any visual or physical impairment that precludes the subject from self-injecting the treatment using RebiSmart™
• • Have received previous treatment with Rebif within 5 years prior to screening.
• • Subjects have any medical, psychiatric or other conditions that compromise his/her ability to understand the subject information, to give informed consent, to comply with the study protocol or to complete the study questionnaires.