Rebif New Formulation (RNF) Quality of Life (QOL) Study - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Uncontrolled, Parallel Assignment
Condition:	Relapsing Multiple Sclerosis
Interventions:	Drug: Rebif New Formulation Non Titrated Drug: Rebif New Formulation Titrated

Participant Flow

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

Baseline Characteristics

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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

Outcome Measures

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1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

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 ]

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Measure Type	Secondary
Measure Title	Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
Measure Description	The MSTCQ in all domains assesses quality of life. The score for all domains other than the Global Side Effect ranges from 17 (most favorable) to 85 (least favorable). Change calculated as (score at week 12 – score at baseline.
Time Frame	Baseline to Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Rebif New Formulation (RNF) Non-Titrated	Rebif New Formulation Non-Titrated
Rebif New Formulation (RNF) - Titrated	Rebif New Formulation - Titrated
All Rebif New Formulation (RNF) Subjects	All subjects combined in Intent to Treat (ITT) Population

Measured Values

	Rebif New Formulation (RNF) Non-Titrated	Rebif New Formulation (RNF) - Titrated	All Rebif New Formulation (RNF) Subjects
Number of Participants Analyzed [units: participants]	117	113	230
Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) [units: score on scale] Mean ± Standard Deviation
Injection System Satisfaction Domain	-3.2 ± 4.0	-2.9 ± 4.1	-3.1 ± 4.1
Side Effects Domain	-3.3 ± 6.4	-2.3 ± 5.7	-2.8 ± 6.1
Flu-Like Systems Domain	-0.9 ± 3.6	-0.7 ± 3.6	-0.8 ± 3.6
Injection Site Reactions Domain	-1.8 ± 3.2	-1.2 ± 3.0	-1.5 ± 3.1
Total Scores in all above Domains	-6.5 ± 8.8	-5.3 ± 7.6	-5.9 ± 8.2

Statistical Analysis 1 for Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)

Groups ^[1]	All Rebif New Formulation (RNF) Subjects
Method ^[2]	t-test, 1 sided
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Change in total score from baseline to week 12 for all subjects combined. Lower scores indicate a more favorable response
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Paired t-test for change from baseline to week 12
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value refers to change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ for all subjects combined.

Statistical Analysis 2 for Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)

Groups ^[1]	Rebif New Formulation (RNF) Non-Titrated vs. Rebif New Formulation (RNF) - Titrated
Method ^[2]	ANOVA
P Value ^[3]	0.178

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Analysis evaluated differences between treatment groups in change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ. Lower scores indicate a more favorable response.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value refers to differences between treatment groups in change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ.

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

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6. Secondary:

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

Show Outcome Measure 6

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Neither Institution nor any Principal Investigators shall publish or present any results from such Study to any third parties until: (i) EMD Serono publishes the results from all sites participating in such Study; (ii) Institution receives notification from EMD Serono that publication of the multi-site results is no longer planned; or (iii) twenty-four (24) months following the completion of the multi-site study at all sites, whichever occurs first.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Fernando Dangond, MD
Organization: EMD Serono, INc.
phone: 781 681 2348
e-mail: fernando.dangond@emdserono.com

No publications provided

Responsible Party:	EMD Serono, Inc ( Ahmad Al-Sabbagh, Vice President Medical Affairs, US Neurology )
Study ID Numbers:	27955
Study First Received:	May 10, 2007
Results First Received:	February 18, 2009
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00472797 History of Changes
Health Authority:	United States: Food and Drug Administration