Rebif New Formulation in Relapsing Forms of Multiple Sclerosis - Full Text View

Sponsors and Collaborators:	EMD Serono Pfizer
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00110396

Purpose

The primary objective of the study is to compare the antigenicity of the new fetal bovine serum (FBS)-free/human serum albumin (HSA)-free Rebif® formulation (RNF) to historical data.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Interferon-beta-1a FBS-free/HSA-free	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicentre, Single Arm, Open-Label, Phase IIIB Study to Evaluate the Safety and Antigenicity of Rebif® (IFN-Beta-1a) in Subjects With Relapsing Forms of Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta Interferon-beta Interferon beta 1a Interferons

U.S. FDA Resources

Further study details as provided by EMD Serono:

Primary Outcome Measures:

Proportion of subjects who are NAb positive at the Week 96 visit. [ Time Frame: At week 96 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary endpoints include various antigenicity measurements. [ Time Frame: At various time points ] [ Designated as safety issue: No ]

Enrollment:	230
Study Start Date:	January 2005
Estimated Study Completion Date:	November 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks.

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. 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. 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. The design of this study assumes that the Phase I tolerability and pharmacokinetic (PK) data of the selected formulation is similar to the currently approved HSA-containing formulation.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has a relapsing form of Multiple Sclerosis (MS); diagnosis of MS is in accordance with the McDonald criteria
Subject is eligible for interferon therapy
Subject is between 18 and 60 years old
Subject has an Expanded Disability Status Scale (EDSS) < 6.0.
Subject is willing to follow study procedures
Subject has given written informed consent
Female subjects 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 subject 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 subject is post-menopausal or surgically sterile.

Exclusion Criteria:

Subject has a Clinically Isolated Syndrome (CIS), Primary Progressive MS, or Secondary Progressive MS without superimposed relapses.
Subject had any prior interferon beta therapy (either beta-1b or beta-1a)
Subject has an ongoing MS relapse.
Subject 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 SD1.
Subject had prior use of cladribine or has previously received total lymphoid irradiation.
Subject received oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 30 days of SD1.
Subject received intravenous immunoglobulins or underwent plasmapheresis within the 6 months prior to SD1.
Subject 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.
Subject requires chronic or monthly pulse corticosteroids during the study.
Subject received any investigational drug or experimental procedure within 12 weeks of SD1.
Subject 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.
Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
Subject suffers from current autoimmune disease.
Subject 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.
Subject has a known allergy to IFN or the excipients.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110396

Locations

United States, Massachusetts
Local US Medical Information
Rockland, Massachusetts, United States, 02370

Sponsors and Collaborators

EMD Serono

Pfizer

Investigators

Study Director:

Bettina Stubinski, MD

Merck Serono International SA

More Information

Additional Information:

Full FDA approved prescribing information can be found here This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	EMD Serono Inc ( Susan Fischer )
Study ID Numbers:	25632
Study First Received:	May 6, 2005
Last Updated:	March 21, 2009
ClinicalTrials.gov Identifier:	NCT00110396 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by EMD Serono:

Multiple Sclerosis
Relapsing forms of multiple sclerosis

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Immunologic Factors
Demyelinating Diseases
Interferons
Adjuvants, Immunologic

Interferon beta 1a
Interferon-beta
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Antiviral Agents
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on July 06, 2009