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 ]

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Measure Type	Primary
Measure Title	Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)
Measure Description	The MSTCQ Global Side Effect domain assesses the degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied). Percent change calculated as 100% * (score at week 12 – score at baseline) / score at baseline.
Time Frame	% change from 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.
Safety: This population includes all subjects who received at least one dose of study drug. To explain difference in number, 1 subject lost to follow-up, 1 subject withdrew consent

Reporting Groups

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

Measured Values

	All Rebif New Formulation (RNF) Subjects
Number of Participants Analyzed [units: participants]	230
Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ) [units: percent change] Mean ± Standard Deviation	5.0 ± 17.7

Statistical Analysis 1 for Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)

Groups ^[1]	All Rebif New Formulation (RNF) Subjects
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	t-test, 1 sided
P Value ^[4]	<0.001
mean ^[5]	2.73
97.5% Confidence Interval	( 2.73 to 2.73 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	A one-sided paired t-test across all subjects by combining the titrated and non-titrated RNF groups was performed.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	The 97.5% one-sided lower confidence bound was 2.73%. -10% is the margin of inferiority.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	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 denotes percent change from baseline to week 12 for all combined subjects.
[5]	Other relevant estimation information:
	No text entered.

2. Secondary:

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

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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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4. Secondary:

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

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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) ]

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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