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| Sponsor: | EMD Serono |
|---|---|
| Information provided by: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT00472797 |
Purpose
To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and injection site redness Rebif treated subjects with relapsing forms of MS who transition to a new formulation of Rebif (RNF).
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsing Multiple Sclerosis |
Drug: Rebif New Formulation Non Titrated Drug: Rebif New Formulation Titrated |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
| Official Title: | A Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF) |
| Enrollment: | 232 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | November 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Rebif New Formulation - Non Titrated
|
Drug: Rebif New Formulation Non Titrated
human interferon beta 1a - Rebif New Formulation
|
|
2: Active Comparator
Rebif New Formulation - Titrated
|
Drug: Rebif New Formulation Titrated
Human interferon beta 1a Rebif New Formulation
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | EMD Serono, Inc ( Ahmad Al-Sabbagh, Vice President Medical Affairs, US Neurology ) |
| Study ID Numbers: | 27955 |
| Study First Received: | May 10, 2007 |
| Results First Received: | February 18, 2009 |
| Last Updated: | September 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00472797 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Infective Agents Autoimmune Diseases Immunologic Factors Demyelinating Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Interferon-beta |
Sclerosis Antiviral Agents Pharmacologic Actions Multiple Sclerosis Pathologic Processes Therapeutic Uses Interferon beta 1a Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |