We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis (RNF)

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
Sponsor:
Collaborator:
Pfizer
Information provided by:
EMD Serono

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary objective of the study is to compare the immunogenicity of the new fetal bovine serum (FBS)-free/human serum albumin (HSA)-free Rebif® formulation (RNF) to historical data.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: Interferon-beta-1a FBS-free/HSA-free Phase 3

Detailed Description:
As has been seen with other recombinant protein molecules, the use of injectable recombinant proteins may result in the development of neutralising antibodies (NAbs). Antibodies are considered neutralising by their ability to inhibit the biological effect of interferon in a bioassay system. EMD Serono has actively pursued improvements in the formulation of interferon (IFN) beta-1a to reduce aggregate levels and to develop a formulation that is HSA-free. Reducing aggregates should reduce antigenicity of the product while removal of HSA may have an unpredictable effect on antigenicity. EMD Serono will conduct a study to assess the immunogenicity and safety of the new HSA-free formulation, manufactured using IFN-ß-1a drug substance produced by a new clone from the FBS-free process.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Massachusetts
Local US Medical Information
Rockland, Massachusetts, United States, 02370
Sponsors and Collaborators
EMD Serono
Pfizer
Investigators
Layout table for investigator information
Study Director: Bettina Stubinski, MD Merck Serono SA - Geneva
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Layout table for additonal information
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
Keywords provided by EMD Serono:
Multiple Sclerosis
Relapsing forms of multiple sclerosis
Additional relevant MeSH terms:
Layout table for MeSH terms
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