Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR)
NCT01080027 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 254
Last updated 2014-07-31
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.
Conditions
- Multiple Sclerosis, Relapsing Remitting
Interventions
- DRUG
-
Rebif® New Formulation
The recommended dose of Rebif® is 22 or 44 μg administered three times per week by subcutaneous injection.
Sponsors & Collaborators
-
Merck A.E., Greece
collaborator INDUSTRY -
Merck OY, Finland
collaborator INDUSTRY -
Merck B.V., Netherlands
collaborator INDUSTRY -
Merck A.B., Sweden
collaborator INDUSTRY -
Merck, S.A., Portugal
collaborator INDUSTRY -
Merck KGaA, Darmstadt, Germany
lead INDUSTRY
Principal Investigators
-
Michalis Arvanitis, MD, MSc · Merck A.E., Greece
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-10-31
- Primary Completion
- 2011-06-30
- Completion
- 2011-06-30
Countries
- Greece
Study Locations
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