Status:
COMPLETED
A Phase IV Study of Rebif ® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After Mitoxantrone
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Gesellschaft für Therapieforschung mbH
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
In the course of therapy escalation, the multiple sclerosis (MS) subjects with high activity of disease receive mainly mitoxantrone. The duration of therapy is limited because of a cumulative dose for...
Detailed Description
Multiple sclerosis is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. It is characte...
Eligibility Criteria
Inclusion
- Subject who had given written informed consent.
- Subjects with definite RRMS or SPMS with relapses
- Subjects with EDSS 1-6
- Subjects aged between 18-60 years
- Subjects who were escalated to mitoxantrone due to high relapse activity or MRI activity (not due to EDSS progression exclusively)
- Subjects who may not have a confirmed 1 point EDSS progression (0.5 points for EDSS \>5.5) within the last 9 months
- Subjects free of relapses over the last 6 months
- Subjects with last mitoxantrone treatment between 1 and 6 months prior to screening
- Subjects treated with mitoxantrone for minimum 9 months and maximum 36 months, total cumulative dose being 40-120 mg/m\^2
- Female subjects who 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 human chorionic gonadotropin (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
- Subject who has received any cytokine or anti-cytokine therapy within the 3 months prior to study Day 1
- Subject who has been escalated to mitoxantrone due to EDSS progression
- Subject with an ongoing MS relapse
- Subject with PPMS
- Subject with SPMS without superimposed relapses
- Subject who has received immunomodulatory treatment other than IFN-beta or glatiramer acetate before mitoxantrone
- Subject who has previously received total lymphoid irradiation
- Subject who has received oral or systemic corticosteroids or adrenocorticotrophic hormone ACTH within 30 days of study Day 1
- Subject who has received intravenous immunoglobulins or underwent plasmapheresis within the 6 months prior to study day 1
- Subject who has received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, teriflunomide, natalizumab, laquinimod, Campath) within the 12 months prior to study Day 1
- Subject who requires chronic or monthly pulse corticosteroids during the study
- Subject who has received any investigational drug or experimental procedure within 12 month of study Day 1
- Subject who has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase greater than 2.5 times the upper limit of the normal values.
- Subject who has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 times the lower limit of normal
- Subject who suffers from current autoimmune disease
- Subject with known allergy to IFN or the excipient(s)
- Subject who 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 treated with drugs other than IFN-beta or glatiramer acetate within 2 years before mitoxantrone
- Subject with known cardiac or other systemic diseases
- Subjects who are pregnant.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01142466
Start Date
December 1 2005
End Date
January 1 2010
Last Update
February 27 2014
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