Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
EMD Serono
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males and females between 18 and 65 years of age, inclusive
Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either:
* Post-menopausal or surgically sterile, or
* Using a highly effective method of contraception for the duration of the study. This is defined as a method that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s, sexual abstinence or vasectomised partner.
Have RMS according to the revised McDonald Criteria 2005
Have disease duration for at least 3 months
Are currently receiving RNF 44 mcg sc by Rebiject IITM (RII) tiw and have been consistently on therapy for a minimum of 6 weeks prior to Screening
You may not be if
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 patient's MS or the patient's RNF therapy (e.g., influenza or pneumococcus vaccination) will be acceptable
Receive any MS therapy other than Rebif / RNF (e.g., other disease-modifying drug \[DMD\]s: immunomodulatory , immunosuppressive agents or combination therapy) within 12 months prior to study enrolment or at any time during the study
Receive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days prior to SD1
Have inadequate liver function, defined by a alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN), or alkaline phosphatase \> 2 x ULN, or total bilirubin \> 2 x ULN if associated with any elevation of ALT or alkaline phosphatase
Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal
Have moderate to severe renal impairment
History of any chronic pain syndrome
Any visual or physical impairment that precludes the subject self-injecting the treatment using the RebiSmartä
