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

Completed · Phase 3

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00110396

Run by

EMD Serono

People needed

260

Starts

2005-01-01

Expected to finish

2007-04-01

Last updated by the study team

2015-07-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Local US Medical Information — Rockland, Massachusetts, United States

Full record on ClinicalTrials.gov

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