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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Rebif New Formulation - Non Titrated |
|
| 2 | Active Comparator | Rebif New Formulation - Titrated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebif New Formulation Non Titrated | Drug | human interferon beta 1a - Rebif New Formulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | % change from Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline to Each Visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Dangond, MD | EMD Serono | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EMD Serono, Inc. | Rockland | Massachusetts | 02370 | United States |
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| Label | URL |
|---|---|
| Full FDA approved prescribing information can be found here | View source |
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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)
232 subjects were recruited from 25 Multiple Sclerosis (MS) Clinics in the US from April 2007 through November 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | New Formulation of Rebif - Non-Titrated | The new formulation of rebif is not approved and under investigation in the US |
| FG001 | New Formulation of Rebif - Titrated | The new frmulation of rebif is not approved and under investigation in the US |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | New Formulation of Rebif - Non-Titrated | |
| BG001 | New Formulation of Rebif - Titrated | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | May 2010 | Mean | Standard Deviation | percent change | % change from Baseline to Week 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-Titrated | New formulation of rebif |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Artrial fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fernando Dangond, MD | EMD Serono, INc. | 781 681 2348 | fernando.dangond@emdserono.com |
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| Rebif New Formulation Titrated |
| Drug |
Human interferon beta 1a Rebif New Formulation |
|
| 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. |
| Baseline to Week 12 |
| 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). | Baseline to Week 12 |
| 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. | Baseline to Week 12 |
| 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. | Baseline to Week 12 (LOCF) |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
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| 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). | Intent to Treat (ITT) and Last Observation Carried Forward (LOCF) Higher scores indicate a more favorable response | Posted | Feb 2009 | Mean | Standard Deviation | score on scale | Baseline and Week 12 |
|
|
|
|
| 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. | Posted | May 2010 | Mean | Standard Deviation | score on scale | Baseline to Week 12 |
|
|
|
|
| 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). | ITT and LOCF | Posted | May 2010 | Mean | Standard Deviation | score on scale | Baseline to Week 12 |
|
|
|
|
| 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. | ITT | Posted | May 2010 | Number | Participants | Baseline to Week 12 |
|
|
|
| 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. | ITT and LOCF | Posted | Feb 2009 | Mean | Standard Deviation | mm | Baseline to Week 12 (LOCF) |
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|
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| 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. | ITT | Posted | May 2010 | Mean | Standard Deviation | Score | Change from Baseline to Each Visit |
|
|
|
|
| 10 |
| 118 |
| 90 |
| 118 |
| EG001 | Titrated | New formulation of rebif | 6 | 113 | 78 | 113 |
| EG002 | All New Formulation of Rebif Subjects | All subjects combined in Intent to Treat (ITT) Population | 16 | 231 | 168 | 231 |
| Cardiomiopathy | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Haemangiopericytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Renal Artery Fibromuscular Dysplasia | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Secondary Hypertension | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Suicidal ideation | Social circumstances | MedDRA 10.0 | Non-systematic Assessment |
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| Thyrotoxic crisis | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Influenza-like Illness | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
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.
|
| Percent Change - Baseline to Week 12 (LOCF) |
|
P-value denotes the mean percent change from baseline to week 12. |
| 95 |
| No |
| Superiority or Other |
| t-test, 1 sided | 0.003 | P-value denotes the mean percent change from baseline to week 12. | 95 | No | Superiority or Other |
|
| Flu-Like Systems Domain |
|
| Injection Site Reactions Domain |
|
| Total Scores in all above Domains |
|
|
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. |
| ANOVA |
| 0.110 |
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. |
| 95 |
| No |
| Superiority or Other |
|
|
| Physical Component -Change from Baseline to Wk 36 |
|
| Physical Component -Baseline to Ext. Visit 1 |
|
| Physical Component -Baseline to Ext Visit 3 |
|
| Physical Component -Baseline to Exit Visit/LOCF |
|
| Mental Component - Baseline |
|
| Mental Component - Change from Baseline to Week 12 |
|
| Mental Component - Change from Baseline to Week 36 |
|
| Mental Component - Baseline to Ext Visit 1 |
|
| Mental Component - Baseline to Ext Visit 3 |
|
| Mental Component - Baseline to Exit/LOCF |
|
Paired |
| 0.234 |
| 95 |
| No |
| Superiority or Other |
| Physical Component - Change from Baseline to Extension Visit 1 | t-test, 2 sided | Paired | 0.001 | 95 | No | Superiority or Other |
| Physical Component - Change from Baseline to Extension Visit 3 | t-test, 2 sided | Paired | 0.004 | 95 | No | Superiority or Other |
| Physical Component - Change from Baseline to Exisit Visit LOCF | t-test, 2 sided | Paired | 0.036 | 95 | No | Superiority or Other |
| Mental Component - Baseline to Week 12 | t-test, 2 sided | Paired | 0.002 | 95 | No | Superiority or Other |
| Mental Component - Baseline to Week 36 | t-test, 2 sided | Paired | 0.468 | 95 | No | Superiority or Other |
| Mental Component - Change from Baseline to Extension Visit 1 | t-test, 2 sided | Paired | 0.602 | 95 | No | Superiority or Other |
| Change from Baseline to Extension Visit 3 | t-test, 2 sided | Paired | 0.414 | 95 | No | Superiority or Other |
| Change from Baseline to Exit Visit LOCF | t-test, 2 sided | Paired | 0.991 | 95 | No | Superiority or Other |