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Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting.

NCT01101776 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 49

Last updated 2014-08-13

No results posted yet for this study

Summary

This observational multicentric study is planned to assess the tolerability of Rebif New Formulation in an Australian clinical setting by the incidence of injection site reactions (ISRs). The study will allow the comparison of tolerability data with historical data for both Rebif New and classic formulations, and will do so by using the same pre- specified preferred terms of treatment emergent adverse events as done in historical studies. In addition, the study will analyse whether interaction(s) with a nurse impacts tolerability and the impact of Rebif New Formulation on the patient's Quality of Life.

Conditions

Interventions

DRUG

Interferon beta-1a (Rebif)

Interferon beta-1a 44 micrograms (12 MIU) given three times per week (tiw) by subcutaneous injection (SCI). Dose to be reduced to 22 micrograms (6 MIU) tiw by SCI for subjects who cannot tolerate the higher dose.

Sponsors & Collaborators

  • Merck Serono Australia Pty Ltd

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Lynn Sartori · Merck Serono Australia Pty Ltd

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT01101776 on ClinicalTrials.gov