Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
232 subjects were recruited from 25 Multiple Sclerosis (MS) Clinics in the US from April 2007 through November 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Run-in period (up to 30 days) on Rebif® 44 mcg tiw: The run-in period included a Screening Visit; assessments consisted of informed consent, medical/disease history, physical exam and laboratory assessments which were performed in the two-week period prior to Study Day 1, (prior to the first dose of Rebif New Formulation (RNF).

Reporting Groups

	Description
Rebif New Formulation (RNF) Non-Titrated	Rebif New Formulation Non-Titrated
Rebif New Formulation (RNF) - Titrated	Rebif New Formulation - Titrated

Participant Flow:   Overall Study

	Rebif New Formulation (RNF) Non-Titrated	Rebif New Formulation (RNF) - Titrated
STARTED	119	113
COMPLETED	115	112
NOT COMPLETED	4	1

Reporting Groups

	Description
Rebif New Formulation (RNF) - Non-Titrated	No text entered.
Rebif New Formulation (RNF) - Titrated	No text entered.

Baseline Measures

	Rebif New Formulation (RNF) - Non-Titrated	Rebif New Formulation (RNF) - Titrated	Total
Number of Participants   [units: participants]	119	113	232
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	119	113	232
>=65 years	0	0	0
Age   [units: years] Mean ± Standard Deviation	44.6 ± 9.0	42.8 ± 9.4	43.7 ± 9.2
Gender   [units: participants]
Female	91	89	180
Male	28	24	52
Region of Enrollment   [units: participants]
United States	119	113	232

1.  Primary:

Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)   [ % change from Baseline to Week 12 ]

2.  Secondary:

Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)   [ Baseline and Week 12 ]

3.  Secondary:

Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)   [ Baseline to Week 12 ]

4.  Secondary:

Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12   [ Baseline to Week 12 ]

5.  Secondary:

Tolerability in Pain Using Visual Analog Scale (VAS)   [ Baseline to Week 12 ]

6.  Secondary:

Tolerability - Redness at Injection Site   [ Baseline to Week 12 (LOCF) ]