Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Date of first subject first visit: 15 Dec 2006. Date of last subject last visit: 28 Nov 2008. Twenty five trial centers enrolled subjects in the following countries: Bulgaria (7), Canada(2), Estonia (2), Germany (1), Italy(2), Lithuania (1), Romania (1), Russian Federation (4), Serbia (2), and Spain (3).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects meeting the eligibility criteria during a screening period of up to 14 days were randomly assigned in a 2:1 ratio to receive either RNF 44 mcg s.c. tiw or matching placebo for 16 weeks. There were 33 screening failures: subjects who did not meet all eligibility criteria (n=29), subject withdrawal of consent (n=3), and “lost of view” (n=1)

Reporting Groups

	Description
Rebif New Formulation	RNF 44 mcg s.c. tiw for 40 weeks
Placebo Followed by Rebif New Formulation	Matching placebo for 16 weeks, then RNF 44 mcg s.c. tiw for remaining 24 weeks

Participant Flow:   Overall Study

	Rebif New Formulation	Placebo Followed by Rebif New Formulation
STARTED	120 [1]	60 [1]
COMPLETED	109	56
NOT COMPLETED	11	4
Adverse Event	2	1
Death	1	0
Disease Progression	2	0
Lost to Follow-up	1	0
Protocol Violation	1	0
Patient unable to use Rebiject II	1	0
Patient refused MRI	1	0
Inclusion criteria absent	1	0
Non-compliant	0	1
Patient decided to withdraw	1	0
Patient's reason	0	1
Patient decided to stop	0	1

Reporting Groups

	Description
Rebif New Formulation	RNF 44 mcg s.c. tiw for 40 weeks
Placebo Followed by Rebif New Formulation	Matching placebo for 16 weeks, then RNF 44 mcg s.c. tiw for remaining 24 weeks

Baseline Measures

	Rebif New Formulation	Placebo Followed by Rebif New Formulation	Total
Number of Participants   [units: participants]	120	60	180
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	120	60	180
>=65 years	0	0	0
Age   [units: years] Mean ± Standard Deviation	34.0  ± 7.8	35.2  ± 10.5	34.4  ± 8.8
Gender   [units: participants]
Female	88	42	130
Male	32	18	50
Region of Enrollment   [units: participants]
Bulgaria	40	12	52
Canada	3	3	6
Estonia	8	5	13
Germany	1	0	1
Italy	7	4	11
Lithuania	5	3	8
Romania	11	8	19
Russian Federation	20	12	32
Serbia	20	9	29
Spain	5	4	9

1.  Primary:

Number of Combined Unique (CU) Active MRI Lesions at Week 16   [ Time Frame: 16 Weeks ]

2.  Secondary:

To Evaluate the Efficacy of RNF by Comparing the Mean Number of Combined Unique (CU) Lesions Per Scan Per Subject Between the Initial 16 Weeks of Placebo Treatment and 24 Weeks of RNF Treatment in the Same Subjects, Originally Randomized to Placebo.   [ Time Frame: Various timepoints ]

3.  Primary:

Efficacy - MRI, Neurological Examination, Safety - Incidence, Severity, and Relationship to the Study Drug of Treatment Emergent Adverse Events, Serious Adverse Events, Laboratory Abnormalities, and Binding and Neutralizing Antibodies to IFN-Beta-1a   [ Time Frame: Various Timepoints ]

4.  Secondary:

Difference in Mean Number of CU Active Lesions Per Subject Per Scan in Originally Randomized Placebo Subjects, Over the Following Treatment Periods: Trial Day 1 Through Week 16, and Weeks 17 Through 40   [ Time Frame: 40 Weeks ]