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Rebif New Formulation (RNF) Quality of Life (QOL) Study (RebiQoL)
This study is ongoing, but not recruiting participants.
Study NCT00472797   Information provided by EMD Serono
First Received: May 10, 2007   Last Updated: September 9, 2009   History of Changes
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
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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 ]

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 ]

Measure Type Secondary
Measure Title Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
Measure Description The MSTCQ Global Side Effect domain assesses the subjects degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied).
Time Frame Baseline and 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.
Intent to Treat (ITT) and Last Observation Carried Forward (LOCF) Higher scores indicate a more favorable response

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
Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
[units: score on scale]
Mean ± Standard Deviation 		     
Mean GSE at Baseline 13.4 ± 1.7 13.4 ± 1.8 13.4 ± 1.7
Mean GSE at Week 12 (LOCF) 14.0 ± 1.6 13.8 ± 1.6 13.9 ± 1.6
Percent Change - Baseline to Week 12 (LOCF) 5.5 ± 16.5 4.5 ± 18.8 5.0 ± 17.7


Statistical Analysis 1 for Total Score for 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] 0.465
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[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 denotes difference between treatment groups

Statistical Analysis 2 for Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
Groups [1] Rebif New Formulation (RNF) Non-Titrated
Method [2] t-test, 1 sided
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[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 denotes the mean percent change from baseline to week 12.

Statistical Analysis 3 for Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
Groups [1] Rebif New Formulation (RNF) - Titrated
Method [2] t-test, 1 sided
P Value [3] 0.003
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[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 denotes the mean percent change from baseline to 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 ]

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 ]

Measure Type Secondary
Measure Title Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12
Measure Description The SF-MPQ assesses Tolerability of Pain with 15 questions to evaluate the type and severity of pain experienced 60 minutes after an injection of study drug. Scores range from 0 (no pain) to 45 (severe pain).
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.
ITT and LOCF

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] 		116 113 229
Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12
[units: score on scale]
Mean ± Standard Deviation 		1.0 ± 3.9 0.8 ± 4.0 0.9 ± 4.0


Statistical Analysis 1 for Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12
Groups [1] Rebif New Formulation (RNF) Non-Titrated vs. Rebif New Formulation (RNF) - Titrated
Method [2] ANOVA
P Value [3] 0.403
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Analysis evaluates total score from baseline to week 12 for differences between each treatment group.
[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 differneces in total score from baseline to week 12 between treatment groups.



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

Measure Type Secondary
Measure Title Tolerability in Pain Using Visual Analog Scale (VAS)
Measure Description The SF-MPQ included a visual analog scale, ranging from 0 to 100 mm, on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm). A rating of <5 mm was considered pain-free.
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.
ITT

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] 		119 113 232
Tolerability in Pain Using Visual Analog Scale (VAS)
[units: Participants]
 		     
Baseline - No. of Subjects Pain Free 52 48 100
Week 12 - No. of Subjects Pain Free 53 48 101

No statistical analysis provided for Tolerability in Pain Using Visual Analog Scale (VAS)



6.  Secondary:   Tolerability - Redness at Injection Site   [ Baseline to Week 12 (LOCF) ]

Measure Type Secondary
Measure Title Tolerability - Redness at Injection Site
Measure Description Change in Baseline to Week 12 Last Observation Carried Forward(LOCF)- A blinded assessment of injection site redness was conducted by a health care professional (1-72 hours) after the most recent injection measuring redness at its widest diameter in mm. Diameter of Redness, lower is better.
Time Frame Baseline to Week 12 (LOCF)  
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.
ITT and LOCF

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] 		114 110 224
Tolerability - Redness at Injection Site
[units: mm]
Mean ± Standard Deviation 		-2.3 ± 27.7 -3.1 ± 28.3 -2.7 ± 27.9


Statistical Analysis 1 for Tolerability - Redness at Injection Site
Groups [1] Rebif New Formulation (RNF) Non-Titrated vs. Rebif New Formulation (RNF) - Titrated
Method [2] ANOVA
P Value [3] 0.899
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Analysis evaluates differences between treatment groups in change in diameter of injection site redness from baseline to week 12.
[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 denotes differences between treatment groups in change in diameter of injection site redness from baseline to week 12.




  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:
unchecked 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.
unchecked 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.


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





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