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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with relapsing-remitting multiple sclerosis (RRMS) by comparing the mean change in injection site pain scores from pre-injection to 30 minutes post therapy administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | interferon beta-1a |
|
| 2 | Active Comparator | interferon beta-1b |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Formulation of rebif - human interferon beta-1a | Drug | New Formulation of rebif- 44 mcg, SC (sub-cutaneous) thrice weekly (tiw) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) of Patient Reported Pain: Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 30 Minutes Post-injection Timepoints | Subject reported perception of pain on the VAS where the slash drawn by the patient represents pain of increasing intensity from 0 (no pain) to 100 (worse possible pain), measured in millimeters. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 30 minutes post-injection | From pre-injection to 30 minutes post injection of the VAS pain scores across the first 21 injections of full dose therapy of a new formulation of rebif and Betaseron |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and Immediately After Injection Timepoints | A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection. | Pre-Injection to Immediately after Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome - Extension Phase: Change in Mean (mm) VAS for Pre-injection and Immediately After Injection Timepoints | A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection. |
Inclusion Criteria:
Subject with diagnosis of RRMS according to McDonald criteria or Poser
Subject is between 18 and 60 years old inclusive
Subject is willing to follow study procedures
Subject has given written informed consent
Female subjects must be neither pregnant nor breast-feeding and must lack childbearing potential, as defined by either:
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 Med Info | Rockland | Massachusetts | 02370 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23216674 | Derived | Singer B, Bandari D, Cascione M, LaGanke C, Huddlestone J, Bennett R, Dangond F; REFORMS Study Group. Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferonbeta-1a versus subcutaneous interferonbeta-1b: results of the randomized, multicenter, Phase IIIb REFORMS study. BMC Neurol. 2012 Dec 6;12:154. doi: 10.1186/1471-2377-12-154. |
| Label | URL |
|---|---|
| Full FDA approved prescribing information can be found here | View source |
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Subjects had a pre-study evaluation period (screening) within 14 days of Study Day 1 which consisted of informed consent, medical/disease history, physical exam and laboratory assessments.
129 subjects were recruited from 27 Multiple Sclerosis (MS) Clinics in the US from December 2006 through August 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | New Formulation of Rebif | The new formulation of rebif is not approved and under investigation in the US |
| FG001 | Betaseron |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Comparative Phase |
| |||||||||||||
| Extension Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | New Formulation of Rebif | Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week |
| BG001 | Betaseron | Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Visual Analog Scale (VAS) of Patient Reported Pain: Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 30 Minutes Post-injection Timepoints | Subject reported perception of pain on the VAS where the slash drawn by the patient represents pain of increasing intensity from 0 (no pain) to 100 (worse possible pain), measured in millimeters. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 30 minutes post-injection | One subject from the new formulation of rebif group discontinued due to pregnancy therefore, data for the Full Dose Calculation 30min Mean Change was not calculated | Posted | Nov 2008 | Mean | Full Range | mm | From pre-injection to 30 minutes post injection of the VAS pain scores across the first 21 injections of full dose therapy of a new formulation of rebif and Betaseron |
|
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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 | New Formulation of Rebif | Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fernando Dangond, MD | EMD Serono, Inc. | 781-681-2348 | fernando.dangond@emdserono.com |
Not provided
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068576 | Interferon beta-1b |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| Interferon beta -1b | Drug | Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection. |
|
| Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 10 Minutes Post-injection Timepoints | A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 10 minutes post injection. | Pre-injection to 10 minutes post-injection |
| Number of Pain Free Patients at 30 Minutes Post-injection | A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Pain-free was defined as a VAS score of 0 for all 21 full-dose injections for the Intent-to-Treat (ITT) population. | 30 minutes post injection |
| Diameter of Injection Site Redness | Blinded assessment of mean change in diameter of redness (in mm) at an injection site following an injection | 1-72 hours post injection over the first 12 weeks including the titration period |
| Pre-injection and immediately after injection |
| Secondary Outcome - Extension Phase: Change in Mean VAS at Pre-injection and 10 Minutes Post Injection | Pre-injection and 10 minutes post injection |
| Secondary Outcome - Extension Phase: Number of Pain Free Patients at 30 Minutes Post Injection | Pain free patients at 30 minutes post injection |
| Secondary Outcome - Extension Phase: Diameter in Injection Site Redness | 1 to 72 hours post injection |
| Primary Outcome - Extension Phase: Visual Analog Scale (VAS) of Patients Reported Pain; Change in Mean VAS at Pre-injection and 30 Minutes Post Injection | Pre-injection and 30 minutes post injection |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
| OG001 | Betaseron | Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day |
|
|
|
| Secondary | Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and Immediately After Injection Timepoints | A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection. | One subject from the new formulation of rebif group discontinued due to pregnancy | Posted | Feb 2009 | Mean | Full Range | millimeters | Pre-Injection to Immediately after Injection |
|
|
|
|
| Secondary | Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 10 Minutes Post-injection Timepoints | A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 10 minutes post injection. | One subject from the new formulation of Rebif group discontinued due to pregnancy | Posted | Feb 2009 | Mean | Full Range | Millimeters | Pre-injection to 10 minutes post-injection |
|
|
|
|
| Secondary | Number of Pain Free Patients at 30 Minutes Post-injection | A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Pain-free was defined as a VAS score of 0 for all 21 full-dose injections for the Intent-to-Treat (ITT) population. | One subject from the new formulation of rebif group discontinued due to pregnancy | Posted | Feb 2009 | Number | Participants | 30 minutes post injection |
|
|
|
|
| Secondary | Diameter of Injection Site Redness | Blinded assessment of mean change in diameter of redness (in mm) at an injection site following an injection | One subject from the new formulation of rebif group discontinued due to pregnancy | Posted | Nov 2008 | Mean | Standard Deviation | mm | 1-72 hours post injection over the first 12 weeks including the titration period |
|
|
|
|
| Other Pre-specified | Secondary Outcome - Extension Phase: Change in Mean (mm) VAS for Pre-injection and Immediately After Injection Timepoints | A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection. | 3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase | Posted | Jun 2010 | Mean | Full Range | millimeters | Pre-injection and immediately after injection |
|
|
|
| Other Pre-specified | Secondary Outcome - Extension Phase: Change in Mean VAS at Pre-injection and 10 Minutes Post Injection | 3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase | Posted | Jun 2010 | Mean | Full Range | Millimeters | Pre-injection and 10 minutes post injection |
|
|
|
| Other Pre-specified | Secondary Outcome - Extension Phase: Number of Pain Free Patients at 30 Minutes Post Injection | 3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase | Posted | Jun 2010 | Number | Participants | Pain free patients at 30 minutes post injection |
|
|
|
| Other Pre-specified | Secondary Outcome - Extension Phase: Diameter in Injection Site Redness | 3 subjects discontinued and withdrew consent from the Betaseron to Rebif New Formulation Group in the Extension Phase | Posted | Jun 2010 | Mean | Standard Deviation | Millimeters | 1 to 72 hours post injection |
|
|
|
| Other Pre-specified | Primary Outcome - Extension Phase: Visual Analog Scale (VAS) of Patients Reported Pain; Change in Mean VAS at Pre-injection and 30 Minutes Post Injection | 3 subjects discontinued and withdrew consent from the Betaseron to the new formulation of rebif group in the Extension Phase | Posted | Jun 2010 | Mean | Full Range | Millimeters | Pre-injection and 30 minutes post injection |
|
|
|
| 4 |
| 65 |
| 62 |
| 65 |
| EG001 | Betaseron | Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day | 5 | 64 | 57 | 64 |
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cholelithiasis / gallstones | Hepatobiliary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Chronic Hepatits | Hepatobiliary disorders | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal PainUpper | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Anaphylactic Reaction | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Blindness | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chronic Hepatitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dental Caries | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dental Discomfort | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Eustachian Tube Obstruction | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Eye Pain | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| General Disorders and Administration site condition | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gingival Pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Halo Vision | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
|
| Infections and Infestations | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Investigations | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Iritis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Iron Defficiency Anamia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Lip Dry | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Middle Ear Effusion | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Mouth Ulceration | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Phychiatric | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Platelet Disorder | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment |
|
| Renal Disorder | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Reproductive system and breast disorder | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Skin disorders | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Stomach Discomfort | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tongue Ulceration | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tooth Disorder | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Visual Disturbance | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal 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.
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |