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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01080027 on ClinicalTrials.gov