Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis (RNF)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00110396 |
Recruitment Status :
Completed
First Posted : May 9, 2005
Results First Posted : July 9, 2010
Last Update Posted : July 15, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Biological: Interferon-beta-1a FBS-free/HSA-free | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 260 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicentre, Single Arm, Open-Label, Phase IIIB Study to Evaluate the Safety and Antigenicity of Rebif® (Interferon-beta-1a) in Subjects With Relapsing Forms of Multiple Sclerosis |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | April 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Rebif New Formulation Cohort |
Biological: Interferon-beta-1a FBS-free/HSA-free
Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks. |
- Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit. [ Time Frame: 96 weeks ]The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.
- Number of Participants Who Were Neutralising Antibody (NAb) Positive at Anytime During the Study [ Time Frame: 96 weeks ]The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.
- Number of Participants With Binding Antibodies (BAb) at Week 96 [ Time Frame: 96 weeks ]Presence of BAbs. BAbs were measured by ELISA (Enzyme-linked immunosorbent assay).

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participant has a relapsing form of Multiple Sclerosis (MS); diagnosis of MS is in accordance with the McDonald criteria
- Participant is eligible for interferon therapy
- Participant is between 18 and 60 years old
- Participant has an Expanded Disability Status Scale (EDSS) < 6.0.
- Participant is willing to follow study procedures
- Participant has given written informed consent
- Female participants must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:
- Being post-menopausal or surgically sterile, or
- Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study.
- Confirmation that the participant is not pregnant must be established by a negative serum or urinary hCG test within 7 days prior to start of study treatment. A pregnancy test is not required if the participant is post-menopausal or surgically sterile.
Exclusion Criteria:
- Participant has a Clinically Isolated Syndrome (CIS), Primary Progressive MS, or Secondary Progressive MS without superimposed relapses.
- Participant had any prior interferon beta therapy (either beta-1b or beta-1a)
- Participant has an ongoing MS relapse.
- Participant received any other approved disease modifying therapy for MS (e.g. glatiramer acetate) or any cytokine or anti-cytokine therapy within the 3 months prior to Study Day 1(SD1).
- Participant had prior use of cladribine or has previously received total lymphoid irradiation.
- Participant received oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 30 days of SD1.
- Participant received intravenous immunoglobulins or underwent plasmapheresis within the 6 months prior to SD1.
- Participant received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone, teriflunomide, natalizumab, laquinimod, Campath) within the 12 months prior to SD1.
- Participant requires chronic or monthly pulse corticosteroids during the study.
- Participant received any investigational drug or experimental procedure within 12 weeks of SD1.
- Participant has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of the normal values.
- Participant has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
- Participant suffers from current autoimmune disease.
- Participant suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol.
- Participant has a known allergy to IFN or the excipients.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110396
United States, Massachusetts | |
Local US Medical Information | |
Rockland, Massachusetts, United States, 02370 |
Study Director: | Bettina Stubinski, MD | Merck Serono SA - Geneva |
Publications of Results:
Responsible Party: | Susan Fischer, EMD Serono Inc |
ClinicalTrials.gov Identifier: | NCT00110396 |
Other Study ID Numbers: |
25632 |
First Posted: | May 9, 2005 Key Record Dates |
Results First Posted: | July 9, 2010 |
Last Update Posted: | July 15, 2015 |
Last Verified: | June 2015 |
Multiple Sclerosis Relapsing forms of multiple sclerosis |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Interferons Interferon-beta Interferon beta-1a Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |