Status:
COMPLETED
REbif FLEXible Dosing in Early Multiple Sclerosis (MS)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical trial with an optional 12 months open label extension. The primary objective of the study is to evaluate t...
Eligibility Criteria
Inclusion
- Single, first clinical event suggestive of MS within 60 days prior to study Day 1, which is the day of randomization (clock starts 24 hours after onset). The event must be a new neurological abnormality present for at least 24 hours, either mono- or polysymptomatic, other than a paresthesia, vegetative or cerebral dysfunction
- At least two clinically silent lesions on the T2-weighted MRI scan, with a size of at least 3 millimeter (mm), at least one of which is ovoid or periventricular or infratentorial
- EDSS 0 - 5.0 at least one time point during the screening period before start of treatment
- 18 and 50 years old, inclusive
- Willing to follow study procedures
- Written informed consent
- If female, subject must:
- be neither pregnant nor breast-feeding nor attempting to conceive
- use a highly effective method of contraception. A highly effective method of contraception is defined as those which result in a low failure rate (that is \[i.e.\] less than 1 percent \[%\] per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner
Exclusion
- Diagnosis of MS (per McDonald criteria 2005)
- Any other disease that could better explain the subject's signs and symptoms
- Complete transverse myelitis or bilateral optic neuritis
- Subject uses or has used any other approved MS disease-modifying drug (DMD)
- Any investigational drug or undergone an experimental procedure within 12 weeks prior to study Day 1
- Oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 30 days prior to study Day 1
- Total bilirubin greater than 2.5 times upper limit of normal (ULN)
- Subject has total aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase (ALP) greater than 2.5 times the ULN
- Inadequate bone marrow reserve, defined as a total white blood cell count less than 3.0 x 109 per liter (/L), platelet count less than 75 x 109/L, hemoglobin less than 100 gram per liter (g/L)
- Current autoimmune disease
- Major medical or psychiatric illness (including history of or current severe depressive disorders and/or suicidal ideation) that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
- History of seizures not adequately controlled by treatment
- Cardiac disease, such as angina, congestive heart failure or arrhythmia
- Known allergy to IFN-beta or the excipient(s) of the study medication
- Any condition that could interfere with the MRI evaluation;
- Known allergy to gadolinium-diethylene triamine pentaacetic acid (DTPA)
- Previously participated in this study
- Participated in any clinical trial within the past 6 months
- Any immunomodulatory or immunosuppressive therapy at any time prior to enrollment, including, but not limited to, the following products: any IFN, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod, cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment (e.g. natalizumab, alemtuzumab/Campath, anti-cluster of differentiation 4 \[CD4\]), intravenous, immunoglobulins (Igs), cytokines or anti-cytokine therapy
- Any experimental MS treatment prior to trial entry, including, but not limited to, any statins (if given to prevent MS) and pentoxyfylline
- History of alcohol or drug abuse
- Intolerance or any contraindication to both paracetamol (acetaminophen) and ibuprofen
- Inability to administer subcutaneous injections either by self or by caregiver
- Moderate to severe renal impairment
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
517 Patients enrolled
Trial Details
Trial ID
NCT00404352
Start Date
November 1 2006
End Date
July 1 2011
Last Update
January 24 2014
Active Locations (67)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Mendoza, Argentina
2
Research Site
Sydney, Australia
3
Research Site
Graz, Austria
4
Research Site
Innsbruck, Austria