Status:
COMPLETED
Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects
Lead Sponsor:
EMD Serono
Collaborating Sponsors:
Merck Serono International SA
Conditions:
Multiple Sclerosis, Relapsing-remitting
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, multicenter, parallel-group, open-label study comparing the tolerability of Rebif® injections (44 microgram \[mcg\] administered subcutaneously three times a week) with and witho...
Eligibility Criteria
Inclusion
- Greater than or equal to 18 years of age
- Has relapsing-remitting MS
- Are willing and able to comply with the protocol for the duration of the study
Exclusion
- Has significant leukopenia/lymphopenia (white blood cell count less than (\<) 0.5 times the lower limit of normal)
- Has elevated liver function tests (aspartate aminotransferase \[AST\], Alanine transaminase \[ALT\], or alkaline phosphatase greater than (\>) 2 times the upper limit of normal or total bilirubin \> 1.5 times the upper limit of normal)
- Has an allergy to human serum albumin or mannitol
- Had treatment with an investigational product or procedure within 3 months
- Has the presence of systemic disease or abnormal laboratory findings that might interfere with subject safety, compliance or evaluation of the condition under study
- Has concomitant use of Avonex®, Betaseron®, Copaxone®, or Novantrone®
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
1883 Patients enrolled
Trial Details
Trial ID
NCT00292253
Start Date
January 1 2001
End Date
December 1 2002
Last Update
August 6 2013
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