Relapsing Multiple Sclerosis
Conditions
Brief summary
To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and injection site redness Rebif treated subjects with relapsing forms of MS who transition to a new formulation of Rebif (RNF).
Interventions
DRUGRebif New Formulation Non Titrated
human interferon beta 1a - Rebif New Formulation
DRUGRebif New Formulation Titrated
Human interferon beta 1a Rebif New Formulation
Sponsors
EMD Serono
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Subject with a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria 2. Subject currently taking Rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment 3. Subject currently using Rebiject II and 29 gauge needle 4. Subject is between 18 and 60 years old inclusive 5. Subject is able to read and understand English 6. Subject is willing to follow study procedures 7. Subject has given written informed consent and signed HIPAA 8. Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either: i) Being post-menopausal or surgically sterile, or ii) Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study. (Confirmation required within 30 days prior to start of the study)
Exclusion criteria
1. Use of any other injectable medications on a regular basis during the week prior to the screening period or during the screening or treatment periods. Receiving a single injection for treatment or prophylaxis of a condition unrelated to the subject's multiple sclerosis or the subject's Rebif® therapy (e.g., receiving a influenza or pneumococcus vaccination) is acceptable 2. Subject receiving MS therapy in addition (i.e., combination therapy) to Rebif® within 3 months prior to study enrollment or at any time during study protocol. 3. Subjects who have previously been on Rebif New Formulation (RNF). 4. Subject with progressive forms of Multiple Sclerosis (MS). 5. Subject with history of any chronic pain syndrome. 6. Subject has any other disease apart from MS that could better explain the subjects signs and symptoms. 7. Subject has complete transverse myelitis or bilateral optic neuritis. 8. Subjects that use any investigational drug or experimental procedure within 12 weeks of visit 1. 9. Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1 (prior to enrollment). 10. Subject has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase \> 2.5 times the upper limit of the normal values. 11. Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal. 12. Subject suffers from other current autoimmune disease. 13. Subject suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol 14. Subject is pregnant or attempting to conceive 15. Visual or physical impairment that precludes completion of diaries and questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ) | % change from Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Baseline and Week 12 | 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). |
| 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 | 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. |
| Tolerability in Pain Using Visual Analog Scale (VAS) | Baseline to Week 12 | 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. |
| Tolerability - Redness at Injection Site | Baseline to Week 12 (LOCF) | 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. |
| Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12 | Baseline to Week 12 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| SF-36 Physical and Mental Component Scores | Change from Baseline to Each Visit | Change from Baseline to each visit for Physical and Mental Component scores for SF-36. Score is norm-based with a mean of 50 and a standard deviation of 10. |
Countries
United States
Participant flow
Recruitment details
232 subjects were recruited from 25 Multiple Sclerosis (MS) Clinics in the US from April 2007 through November 2007.
Pre-assignment details
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 a new formulation of rebif)
Participants by arm
| Arm | Count |
|---|---|
| New Formulation of Rebif - Non-Titrated | 119 |
| New Formulation of Rebif - Titrated | 113 |
| Total | 232 |
Baseline characteristics
| Characteristic | New Formulation of Rebif - Titrated | New Formulation of Rebif - Non-Titrated | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical Between 18 and 65 years | 113 Participants | 119 Participants | 232.0 Participants |
| Age Continuous | 42.8 years STANDARD_DEVIATION 9.4 | 44.6 years STANDARD_DEVIATION 9 | 43.7 years STANDARD_DEVIATION 9.2 |
| Region of Enrollment United States | 113 participants | 119 participants | 232.0 participants |
| Sex: Female, Male Female | 89 Participants | 91 Participants | 180.0 Participants |
| Sex: Female, Male Male | 24 Participants | 28 Participants | 52.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 90 / 118 | 78 / 113 | 168 / 231 |
| serious Total, serious adverse events | 10 / 118 | 6 / 113 | 16 / 231 |
Outcome results
Primary
Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)
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
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All New Formulation of Rebif Subjects | Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ) | 5.0 percent change | Standard Deviation 17.7 |
Comparison: A one-sided paired t-test across all subjects by combining the titrated and non-titrated new formulation groups was performed.p-value: <0.00197.5% CI: [2.73, 2.73]t-test, 1 sided
Secondary
Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All New Formulation of Rebif Subjects | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Injection Site Reactions Domain | -1.9 score on scale | Standard Deviation 3.2 |
| All New Formulation of Rebif Subjects | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Flu-Like Systems Domain | -0.9 score on scale | Standard Deviation 3.6 |
| All New Formulation of Rebif Subjects | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Injection System Satisfaction Domain | -3.2 score on scale | Standard Deviation 4 |
| All New Formulation of Rebif Subjects | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Side Effects Domain | -3.3 score on scale | Standard Deviation 6.4 |
| All New Formulation of Rebif Subjects | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Total Scores in all above Domains | -6.7 score on scale | Standard Deviation 8.8 |
| Titrated | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Flu-Like Systems Domain | -0.8 score on scale | Standard Deviation 3.6 |
| Titrated | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Injection System Satisfaction Domain | -2.9 score on scale | Standard Deviation 4.1 |
| Titrated | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Side Effects Domain | -2.3 score on scale | Standard Deviation 5.7 |
| Titrated | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Injection Site Reactions Domain | -1.3 score on scale | Standard Deviation 2.9 |
| Titrated | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Total Scores in all above Domains | -5.3 score on scale | Standard Deviation 7.6 |
| All New Formulation of Rebif Subjects | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Total Scores in all above Domains | -6.0 score on scale | Standard Deviation 8.3 |
| All New Formulation of Rebif Subjects | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Injection Site Reactions Domain | -1.6 score on scale | Standard Deviation 3.1 |
| All New Formulation of Rebif Subjects | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Injection System Satisfaction Domain | -3.1 score on scale | Standard Deviation 4.1 |
| All New Formulation of Rebif Subjects | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Flu-Like Systems Domain | -0.8 score on scale | Standard Deviation 3.6 |
| All New Formulation of Rebif Subjects | Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Side Effects Domain | -2.8 score on scale | Standard Deviation 6.1 |
Comparison: Change in total score from baseline to week 12 for all subjects combined. Lower scores indicate a more favorable responsep-value: <0.001t-test, 1 sided
Comparison: 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.p-value: 0.11ANOVA
Secondary
Tolerability in Pain Using Visual Analog Scale (VAS)
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
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All New Formulation of Rebif Subjects | Tolerability in Pain Using Visual Analog Scale (VAS) | Baseline - No. of Subjects Pain Free | 51 Participants |
| All New Formulation of Rebif Subjects | Tolerability in Pain Using Visual Analog Scale (VAS) | Week 12 - No. of Subjects Pain Free | 53 Participants |
| Titrated | Tolerability in Pain Using Visual Analog Scale (VAS) | Baseline - No. of Subjects Pain Free | 48 Participants |
| Titrated | Tolerability in Pain Using Visual Analog Scale (VAS) | Week 12 - No. of Subjects Pain Free | 48 Participants |
| All New Formulation of Rebif Subjects | Tolerability in Pain Using Visual Analog Scale (VAS) | Baseline - No. of Subjects Pain Free | 101 Participants |
| All New Formulation of Rebif Subjects | Tolerability in Pain Using Visual Analog Scale (VAS) | Week 12 - No. of Subjects Pain Free | 101 Participants |
Secondary
Tolerability - Redness at Injection Site
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)
Population: ITT and LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All New Formulation of Rebif Subjects | Tolerability - Redness at Injection Site | -2.3 mm | Standard Deviation 27.7 |
| Titrated | Tolerability - Redness at Injection Site | -3.1 mm | Standard Deviation 28.2 |
| All New Formulation of Rebif Subjects | Tolerability - Redness at Injection Site | -2.7 mm | Standard Deviation 27.9 |
Comparison: Analysis evaluates differences between treatment groups in change in diameter of injection site redness from baseline to week 12.p-value: 0.899ANOVA
Secondary
Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
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
Population: Intent to Treat (ITT) and Last Observation Carried Forward (LOCF) Higher scores indicate a more favorable response
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All New Formulation of Rebif Subjects | Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Mean GSE at Week 12 (LOCF) | 14.0 score on scale | Standard Deviation 1.6 |
| All New Formulation of Rebif Subjects | Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Mean GSE at Baseline | 13.4 score on scale | Standard Deviation 1.7 |
| All New Formulation of Rebif Subjects | Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Percent Change - Baseline to Week 12 (LOCF) | 5.5 score on scale | Standard Deviation 16.5 |
| Titrated | Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Mean GSE at Week 12 (LOCF) | 13.8 score on scale | Standard Deviation 1.6 |
| Titrated | Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Mean GSE at Baseline | 13.4 score on scale | Standard Deviation 1.8 |
| Titrated | Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Percent Change - Baseline to Week 12 (LOCF) | 4.5 score on scale | Standard Deviation 18.8 |
| All New Formulation of Rebif Subjects | Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Mean GSE at Baseline | 13.4 score on scale | Standard Deviation 1.7 |
| All New Formulation of Rebif Subjects | Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Percent Change - Baseline to Week 12 (LOCF) | 5.0 score on scale | Standard Deviation 17.7 |
| All New Formulation of Rebif Subjects | Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) | Mean GSE at Week 12 (LOCF) | 13.9 score on scale | Standard Deviation 1.6 |
p-value: 0.466ANOVA
p-value: <0.001t-test, 1 sided
p-value: 0.003t-test, 1 sided
Secondary
Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12
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
Population: ITT and LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All New Formulation of Rebif Subjects | Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12 | 0.7 score on scale | Standard Deviation 3.4 |
| Titrated | Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12 | 1.1 score on scale | Standard Deviation 3.9 |
| All New Formulation of Rebif Subjects | Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12 | 0.9 score on scale | Standard Deviation 3.7 |
Comparison: Analysis evaluates total score from baseline to week 12 for differences between each treatment group.p-value: 0.302ANOVA
Other Pre-specified
SF-36 Physical and Mental Component Scores
Change from Baseline to each visit for Physical and Mental Component scores for SF-36. Score is norm-based with a mean of 50 and a standard deviation of 10.
Time frame: Change from Baseline to Each Visit
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Physical Component Score - Baseline | 43.4 Score | Standard Deviation 9.4 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Physical Component -Change from Baseline to Wk 12 | 1.8 Score | Standard Deviation 5.7 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Physical Component -Change from Baseline to Wk 36 | -0.2 Score | Standard Deviation 7.7 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Physical Component -Baseline to Ext. Visit 1 | 2.0 Score | Standard Deviation 6.5 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Physical Component -Baseline to Ext Visit 3 | 1.0 Score | Standard Deviation 6.5 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Physical Component -Baseline to Exit Visit/LOCF | 0.4 Score | Standard Deviation 6.4 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Mental Component - Baseline | 46.1 Score | Standard Deviation 10.9 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Mental Component - Change from Baseline to Week 12 | 2.5 Score | Standard Deviation 8.7 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Mental Component - Change from Baseline to Week 36 | 1.8 Score | Standard Deviation 10.6 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Mental Component - Baseline to Ext Visit 1 | 0.3 Score | Standard Deviation 10.7 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Mental Component - Baseline to Ext Visit 3 | 1.3 Score | Standard Deviation 11.2 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Mental Component - Baseline to Exit/LOCF | -0.1 Score | Standard Deviation 11.2 |
| Titrated | SF-36 Physical and Mental Component Scores | Mental Component - Baseline to Exit/LOCF | 0.1 Score | Standard Deviation 9.7 |
| Titrated | SF-36 Physical and Mental Component Scores | Physical Component Score - Baseline | 43.6 Score | Standard Deviation 9.3 |
| Titrated | SF-36 Physical and Mental Component Scores | Mental Component - Baseline | 46.1 Score | Standard Deviation 10.9 |
| Titrated | SF-36 Physical and Mental Component Scores | Mental Component - Change from Baseline to Week 36 | -0.8 Score | Standard Deviation 10 |
| Titrated | SF-36 Physical and Mental Component Scores | Physical Component -Change from Baseline to Wk 12 | 2.0 Score | Standard Deviation 4.3 |
| Titrated | SF-36 Physical and Mental Component Scores | Physical Component -Baseline to Exit Visit/LOCF | 1.4 Score | Standard Deviation 6.4 |
| Titrated | SF-36 Physical and Mental Component Scores | Mental Component - Baseline to Ext Visit 3 | 0.1 Score | Standard Deviation 10.4 |
| Titrated | SF-36 Physical and Mental Component Scores | Physical Component -Change from Baseline to Wk 36 | 1.5 Score | Standard Deviation 6 |
| Titrated | SF-36 Physical and Mental Component Scores | Mental Component - Change from Baseline to Week 12 | 1.3 Score | Standard Deviation 9.1 |
| Titrated | SF-36 Physical and Mental Component Scores | Physical Component -Baseline to Ext Visit 3 | 2.0 Score | Standard Deviation 6.4 |
| Titrated | SF-36 Physical and Mental Component Scores | Physical Component -Baseline to Ext. Visit 1 | 1.7 Score | Standard Deviation 6.6 |
| Titrated | SF-36 Physical and Mental Component Scores | Mental Component - Baseline to Ext Visit 1 | -1.2 Score | Standard Deviation 8.9 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Physical Component -Baseline to Ext. Visit 1 | 1.9 Score | Standard Deviation 6.5 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Physical Component -Baseline to Ext Visit 3 | 1.5 Score | Standard Deviation 6.4 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Mental Component - Baseline to Ext Visit 1 | -0.4 Score | Standard Deviation 9.8 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Physical Component -Baseline to Exit Visit/LOCF | 0.9 Score | Standard Deviation 6.4 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Mental Component - Baseline | 46.1 Score | Standard Deviation 10.9 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Mental Component - Change from Baseline to Week 12 | 1.9 Score | Standard Deviation 8.9 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Mental Component - Baseline to Ext Visit 3 | 0.7 Score | Standard Deviation 10.8 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Physical Component Score - Baseline | 43.5 Score | Standard Deviation 9.3 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Physical Component -Change from Baseline to Wk 12 | 1.9 Score | Standard Deviation 5 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Mental Component - Change from Baseline to Week 36 | 0.5 Score | Standard Deviation 10.4 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Physical Component -Change from Baseline to Wk 36 | 0.6 Score | Standard Deviation 7 |
| All New Formulation of Rebif Subjects | SF-36 Physical and Mental Component Scores | Mental Component - Baseline to Exit/LOCF | 0.0 Score | Standard Deviation 10.5 |
Comparison: Physical Component - Change from Baseline to Week 12p-value: <0.001t-test, 2 sided
Comparison: Physical Component - Change from Baseline to Week 36p-value: 0.234t-test, 2 sided
Comparison: Physical Component - Change from Baseline to Extension Visit 1p-value: 0.001t-test, 2 sided
Comparison: Physical Component - Change from Baseline to Extension Visit 3p-value: 0.004t-test, 2 sided
Comparison: Physical Component - Change from Baseline to Exisit Visit LOCFp-value: 0.036t-test, 2 sided
Comparison: Mental Component - Baseline to Week 12p-value: 0.002t-test, 2 sided
Comparison: Mental Component - Baseline to Week 36p-value: 0.468t-test, 2 sided
Comparison: Mental Component - Change from Baseline to Extension Visit 1p-value: 0.602t-test, 2 sided
Comparison: Change from Baseline to Extension Visit 3p-value: 0.414t-test, 2 sided
Comparison: Change from Baseline to Exit Visit LOCFp-value: 0.991t-test, 2 sided