Status:
COMPLETED
Rebif New Formulation (RNF) Quality of Life (QOL) Study
Lead Sponsor:
EMD Serono
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and injection site redness Rebif treated subjects with relapsing forms of MS who transition to a new formulation ...
Eligibility Criteria
Inclusion
- Subject with a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria
- Subject currently taking Rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment
- Subject currently using Rebiject II and 29 gauge needle
- Subject is between 18 and 60 years old inclusive
- Subject is able to read and understand English
- Subject is willing to follow study procedures
- Subject has given written informed consent and signed HIPAA
- Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either: i) Being post-menopausal or surgically sterile, or ii) Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study. (Confirmation required within 30 days prior to start of the study)
Exclusion
- Use of any other injectable medications on a regular basis during the week prior to the screening period or during the screening or treatment periods. Receiving a single injection for treatment or prophylaxis of a condition unrelated to the subject's multiple sclerosis or the subject's Rebif® therapy (e.g., receiving a influenza or pneumococcus vaccination) is acceptable
- Subject receiving MS therapy in addition (i.e., combination therapy) to Rebif® within 3 months prior to study enrollment or at any time during study protocol.
- Subjects who have previously been on Rebif New Formulation (RNF).
- Subject with progressive forms of Multiple Sclerosis (MS).
- Subject with history of any chronic pain syndrome.
- Subject has any other disease apart from MS that could better explain the subjects signs and symptoms.
- Subject has complete transverse myelitis or bilateral optic neuritis.
- Subjects that use any investigational drug or experimental procedure within 12 weeks of visit 1.
- Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1 (prior to enrollment).
- 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 other 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 is pregnant or attempting to conceive
- Visual or physical impairment that precludes completion of diaries and questionnaires.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00472797
Start Date
April 1 2007
End Date
November 1 2009
Last Update
August 7 2013
Active Locations (1)
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1
EMD Serono, Inc.
Rockland, Massachusetts, United States, 02370