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| Sponsored by: |
EMD Serono |
|---|---|
| Information provided by: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT00472797 |
Purpose
To evaluate the impact on Quality of Life, tolerability, treatment satisfaction, and injection site redness Rebif treated subjects with relapsing forms of MS who transition to a new formulation of Rebif.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsing Multiple Sclerosis |
Drug: Rebif Human, Interferon beta 1-a Drug: Rebif Human Interferon beta-1a |
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 Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF) |
| Estimated Enrollment: | 222 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: Rebif Human, Interferon beta 1-a
Rebif 44 3x/week
|
| 2: Active Comparator |
Drug: Rebif Human Interferon beta-1a
Rebif Titration
|
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 |
| Last Updated: | January 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00472797 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Interferon Type I, Recombinant Autoimmune Diseases Demyelinating Diseases Immunologic Factors Interferons Adjuvants, Immunologic Interferon-beta Quality of Life |
Sclerosis Angiogenesis Inhibitors Antiviral Agents Multiple Sclerosis Interferon beta 1a Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
|
Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Pathologic Processes Multiple Sclerosis Therapeutic Uses Interferon beta 1a Angiogenesis Modulating Agents Growth Inhibitors Autoimmune Diseases of the Nervous System Autoimmune Diseases |
Immune System Diseases Demyelinating Diseases Growth Substances Interferons Nervous System Diseases Interferon-beta Adjuvants, Immunologic Sclerosis Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Demyelinating Autoimmune Diseases, CNS |