Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR)

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The rationale of this study is to assess the safety profile, efficacy and adherence to Rebif® New Formulation in real life settings with a multinational approach, as well as the impact of this improved formulation (with regards to adverse events [AEs]) to subjects' adherence.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborators: Merck A.B., Sweden; Merck A.E., Greece; Merck B.V., Netherlands; Merck OY, Finland; Merck, S.A., Portugal
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• Subjects with a diagnosis of RRMS according to the Mc Donald criteria(2005)

• 18 to 60 years of age

• Expanded Disability Status Scale (EDSS) < 6

• Naïve subjects or subjects treated with Rebif® New Formulation for no more than 6 weeks prior to enrollment

• Subjects who have given written informed consent to participate in the study

Exclusion Criteria:

• Primary progressive or secondary progressive MS

• Subjects previously administered IFN beta-1a (including Rebif®) or IFN beta-1b or glatiramer acetate or any other immunomodulatory or immunosuppressive agents or any other MS therapy in the past with the exception of Rebif® New Formulation for no more than 6 weeks prior to enrollment

• Subjects receiving oral or systemic corticosteroids or Adrenocorticotrophic hormone within 30 days of visit 1 (prior to enrolment)

• History of any chronic pain syndrome

• Known allergy to IFN or its excipients

• Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure

• 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

• Inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal

• Current or past (within the last 2 years) history of alcohol or drug abuse

• Contra-indications to IFN beta-1a