Tolerability of Rebif® Injection With and Without the Use of Rebiject™
A Randomized, Multicenter, Parallel Group, Open-label Study Comparing the Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing Remitting MS Patients
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Rebif® via Rebiject™Mini
Compared with
- Rebif® via manual injections
What it measured
Main measures
Percentage of subjects with moderate to severe (Grade 3-5) injection site reactions based on physician assessment
Month 3
Safety
Other measures (3)
Number of subjects with any injection site reactions based on physician assessment
Month 3
SafetyPercentage of moderate to severe (Grade 3-5) injection site reactions reported per subject based on subject reports
Baseline up to Month 3
SafetyPercentage of injection site reactions reported per subject based on subject reports
Baseline up to Month 3
Safety
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
* 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 criteria
* 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®
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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 without Rebiject™Mini, an auto-injection device in relapsing-remitting multiple sclerosis (MS) subjects. Subjects will be randomly assigned to either one of the two Rebif® groups in a 1:1 ratio on Study Day 1 stratified by center. Subjects will receive a minimum of 3 months of treatment with Rebif® 44 mcg three times a week and will be asked to assess their injection site reactions on a weekly basis. Clinic visit will occur at 1 and 3 months after the initiation of treatment.
Papers
Loading reviews and guidelines…
History
Started
Jan 2001
Main results due
Dec 2002
Finished
Dec 2002