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

NCT00110396 | Completed Phase 3 Results

• 1 other identifier: 25632
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Relapsing forms of multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Were Neutralising Antibody (NAb) Positive at the Week 96 Visit.

  The NAb positive value was defined as NAb value greater or equal to 20 NU/mL. NAbs were detected using a viral cytopathic assay.

  96 weeks

Secondary Outcomes (2)

• Number of Participants Who Were Neutralising Antibody (NAb) Positive at Anytime During the Study

  96 weeks

• Number of Participants With Binding Antibodies (BAb) at Week 96

  96 weeks

Study Arms (1)

Rebif New Formulation Cohort

EXPERIMENTAL

Biological: Interferon-beta-1a FBS-free/HSA-free

Interventions

Interferon-beta-1a FBS-free/HSA-free BIOLOGICAL

Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks.

Rebif New Formulation Cohort

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMD Serono: lead
• Pfizer: collaborator

Study Sites (1)

Local US Medical Information

Rockland, Massachusetts, 02370, United States

Location

Related Publications (2)

• Giovannoni G, Barbarash O, Casset-Semanaz F, Jaber A, King J, Metz L, Pardo G, Simsarian J, Sorensen PS, Stubinski B; RNF Study Group. Immunogenicity and tolerability of an investigational formulation of interferon-beta1a: 24- and 48-week interim analyses of a 2-year, single-arm, historically controlled, phase IIIb study in adults with multiple sclerosis. Clin Ther. 2007 Jun;29(6):1128-45. doi: 10.1016/j.clinthera.2007.06.002.

  PMID: 17692727 RESULT

• Giovannoni G, Barbarash O, Casset-Semanaz F, King J, Metz L, Pardo G, Simsarian J, Sorensen PS, Stubinski B; Rebif New Formulation Study Group. Safety and immunogenicity of a new formulation of interferon beta-1a (Rebif New Formulation) in a Phase IIIb study in patients with relapsing multiple sclerosis: 96-week results. Mult Scler. 2009 Feb;15(2):219-28. doi: 10.1177/1352458508097299. Epub 2008 Aug 28.

  PMID: 18755819 RESULT

Related Links

• Full FDA approved prescribing information can be found here

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Bettina Stubinski/Medical Responsible
• Organization: Merck Serono SA

+41224143396

Study Officials

• Bettina Stubinski, MD

  Merck Serono SA - Geneva

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 6, 2005
• First Posted: May 9, 2005
• Study Start: January 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: July 15, 2015
• Results First Posted: July 9, 2010

Record last verified: 2015-06

Locations

US (1)