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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-005583-91 | EudraCT Number | ||
| 308084 | Other Identifier | company internal | |
| Avantage | Other Identifier | company internal |
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The purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different autoinjectors.
Original French title of the study: Etude de phase IV, multicentrique, randomisée, ouverte, comparant les réactions et la douleur aux sites d'injection après administration sous-cutanée d'interféron β-1b (Betaferon®) ou interféron β-1a (Rebif®) pendant la période de trois mois d'initiation de la thérapie chez des patients atteints d'une forme récurrente/rémittente de sclérose en plaques.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFNB-1b 250 mcg (Betaseron) via Betaject | Experimental | Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject |
|
| IFNB-1b 250 mcg (Betaseron) via Betaject light | Experimental | Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light |
|
| IFNB-1a 44 mcg (Rebif) via Rebiject II | Active Comparator | Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betaferon/Betaseron | Drug | 250ug administrated with Betaject |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection | An injection site is seen as developing a reaction if the patient's score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed | Up to 3 months assessed every 24 hours after each injection |
| Percentage of Sites Developing a Injection Site Reaction (ISR) Reported by Participants 48 Hours After Each Injection | An injection site is seen as developing a reaction if the patient's score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed | Up to 3 months assessed every 48 hours after each injection |
| Mean Scores of Reaction After Injection Reported by Participants | Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis | Up to 3 months assessed every 24 and 48 hours after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Injection Sites With Pain Reported by Physicians | Up to 3 months | |
| Percentage of Injection Sites Per Participant With Reaction Reported by Physicians | Up to 3 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Scores of Reaction After Injection Reported by Patients Between Different Auto Injectors | Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis | Up to 3 months |
Inclusion Criteria:
Exclusion Criteria:
Any contraindication to the prescription of Betaferon or Rebif, as described in the SmPC of products:
Patient previously included in this study.
Patient previously treated by sub-cutaneous route with either Betaferon or Rebif.
Participation in any clinical trial within the past 30 days involving the investigational drug intake.
Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aix-en-Provence | 13616 | France | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: IFNB-1b 250 Mcg (Betaseron) Via Betaject | Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject |
| FG001 | Group B: IFNB-1b 250 Mcg (Betaseron) Via Betaject Light |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Rebif |
| Drug |
44ug administered with Rebiject II |
|
| Betaferon/Betaseron | Drug | 250ug administrated with Betaject light |
|
| Percentage of Participants Without ISR Reported by Participants |
| Up to 3 months assessed every 24 hours after each injection |
| Percentage of Sites Developing a Severe Reaction 24 Hours After Injection | An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis | Up to 3 months assessed every 24 hours after each injection |
| Percentage of Sites Developing a Severe Reaction 48 Hours After Injection | An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis | Up to 3 months assessed every 48 hours after each injection |
| Percentage of Participants Without Pain Reported by Participants | Up to 3 months assessed 24 hours after each injection |
| Percentage of Injection Sites Without Pain Reported by Physicians | Up to 3 months |
| Percentage of Injection Sites Without Pain Reported by Participants | Up to 3 months assessed 24 hours after each injection |
| Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection | Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain). | Immediately after injection |
| Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection | Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain). | 30 min after injection |
| Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection | Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain). | 1h after injection |
| Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection | Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain). | 24h after injection |
| Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants | Up to 3 months assessed every 24 hours after each injection |
| Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants | if the patient score is missing, at the injection site, then the patient is not considered without or with developping reaction. An injection site is seen as developing no reaction if the patient's score for this site is of a reaction intensity = 0. | Up to 3 months assessed every 48 hours after each injection |
| Alkirch |
| France |
| Annecy | 74011 | France |
| Aurillac | 15000 | France |
| Belfort | France |
| Blaye | France |
| Bordeaux | 33000 | France |
| Boulogne-sur-Mer | 62321 | France |
| Brest | France |
| Brive-la-Gaillarde | 19100 | France |
| Carcassonne | France |
| Castelnau-le-Lez | 34170 | France |
| Chamaliÿres | France |
| Champigny-sur-Marne | France |
| Colmar | France |
| Corbeil Essones Cedex | France |
| Créteil | 94000 | France |
| Dijon | France |
| Dreux | France |
| Dunkirk | 59140 | France |
| Elbeuf | France |
| Évreux | 27023 | France |
| Évry | France |
| La Seyne-sur-Mer | 83500 | France |
| Le Mans | 72000 | France |
| Le Mans | France |
| Libourne | 33505 | France |
| Lille | France |
| Lomme | France |
| Lyon | France |
| Marseille | 13006 | France |
| Montpellier | France |
| Nancy | 54000 | France |
| Nancy | France |
| Nantes | 44000 | France |
| Nice | France |
| Nîmes | 30900 | France |
| Paris | France |
| Pau | France |
| Perpignan | 66000 | France |
| Poissy | France |
| Quimper | 29000 | France |
| Quimper | France |
| Reims | France |
| Rennes | France |
| Rouen | France |
| Rueil-Malmaison | France |
| Saint Lÿ | 50000 | France |
| Saint-Etienne | France |
| Saint-Herblain | 44800 | France |
| Saint-Omer | 62505 | France |
| Saint-Quentin | France |
| Strasbourg | France |
| Toulouse | 31400 | France |
| Tourcoing | France |
| Trélazé | France |
| Vendôme | France |
| Vesoul | 70000 | France |
| Vichy | France |
Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light |
| FG002 | Group C: IFNB-1a 44 Mcg (Rebif) Via Rebiject II | Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II |
| Participants Received Treatment |
|
| Fulfilled Requirement Safety Population |
|
| Fulfilled Requirements PP Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IFNB-1b 250 Mcg (Betaseron) | Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light |
| BG001 | IFNB-1a 44 Mcg (Rebif) Via Rebiject II | Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Number of relapses | Mean | Standard Deviation | Relapses |
| |||||||||||||||
| Expanded disability status scale at screening (EDSS) | The EDSS scores range from 0.0 (normal) to 10.0 (dead). A score of 2 to 3 indicates minimal to moderate disability. | Mean | Standard Deviation | Scores on a scale |
| ||||||||||||||
| Time since diagnosis | Mean | Standard Deviation | Years |
|
| 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 | Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection | An injection site is seen as developing a reaction if the patient's score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed | Posted | Number | Percentage of sites | Up to 3 months assessed every 24 hours after each injection | injection sites per month per patient | Participants |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Sites Developing a Injection Site Reaction (ISR) Reported by Participants 48 Hours After Each Injection | An injection site is seen as developing a reaction if the patient's score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed | Posted | Number | Percentage of sites | Up to 3 months assessed every 48 hours after each injection | Injection sites per month per patient | Participants |
|
| |||||||||||||||||||||||||||||||
| Primary | Mean Scores of Reaction After Injection Reported by Participants | Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis | Posted | Mean | Standard Deviation | Scores on a scale | Up to 3 months assessed every 24 and 48 hours after injection | Injection sites per month per patient | Participants |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Scores of Reaction After Injection Reported by Patients Between Different Auto Injectors | Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis | Posted | Mean | Standard Deviation | Scores on a scale | Up to 3 months | Injection sites per month per patient | Participants |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Injection Sites With Pain Reported by Physicians | Posted | Number | Percentage of sites | Up to 3 months | Injection sites per month per patient | Participants |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Injection Sites Per Participant With Reaction Reported by Physicians | Posted | Number | Percentage of ISR | Up to 3 months | Injection sites per month per patient | Participants |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Without ISR Reported by Participants | Posted | Number | Percentage of participants | Up to 3 months assessed every 24 hours after each injection |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Sites Developing a Severe Reaction 24 Hours After Injection | An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis | Posted | Number | Percentage of sites | Up to 3 months assessed every 24 hours after each injection | Injection sites per month per patient | Participants |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Sites Developing a Severe Reaction 48 Hours After Injection | An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis | Posted | Number | Percentage of sites | Up to 3 months assessed every 48 hours after each injection | Injection sites per month per patient | Participants |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Without Pain Reported by Participants | Posted | Number | Percentage of participants | Up to 3 months assessed 24 hours after each injection |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Injection Sites Without Pain Reported by Physicians | Posted | Number | Percentage of injection sites | Up to 3 months | Injection sites per month per patient | Participants |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Injection Sites Without Pain Reported by Participants | Posted | Number | Percentage of injection sites | Up to 3 months assessed 24 hours after each injection | Injection sites per month per patient | Participants |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection | Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain). | Posted | Mean | Full Range | Scores on a scale | Immediately after injection |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection | Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain). | Posted | Mean | Full Range | Scores on a scale | 30 min after injection |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection | Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain). | Posted | Mean | Full Range | Scores on a scale | 1h after injection |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection | Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain). | Posted | Mean | Full Range | Scores on a scale | 24h after injection |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants | Posted | Number | Percentage of sites | Up to 3 months assessed every 24 hours after each injection | Injection sites per month per patient | Participants |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants | if the patient score is missing, at the injection site, then the patient is not considered without or with developping reaction. An injection site is seen as developing no reaction if the patient's score for this site is of a reaction intensity = 0. | Posted | Number | Percentage of sites | Up to 3 months assessed every 48 hours after each injection | Injection sites per month per patient | Participants |
|
|
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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 | IFNB-1b 250 Mcg (Betaseron) | Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light. Participants at risk from Group A and Group B in Participant flow. | 2 | 150 | 83 | 150 | ||
| EG001 | IFNB-1a 44 Mcg (Rebif) Via Rebiject II | Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II. Participants at risk from Group C in Participant flow. | 1 | 65 | 42 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lumbago | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Cytolitic hepatitis | Hepatobiliary disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (15.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Ophtalmoplegia | Eye disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Hot flush | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA (15.1) | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (15.1) | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (15.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increase | Investigations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increase | Investigations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Transaminase increase | Investigations | MedDRA (15.1) | Non-systematic Assessment |
| |
| Decrease appetite | Metabolism and nutrition disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Hypokalaemie | Metabolism and nutrition disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Lumbago | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Chills | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Insomnia | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (15.1) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Parasomnia | Psychiatric disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Urinary track infection | Renal and urinary disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Ejaculation disorder | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Hospitalization | Surgical and medical procedures | MedDRA (15.1) | Non-systematic Assessment |
| |
| Dizziness | Vascular disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Hematoma | Vascular disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Venous insufficiency | Vascular disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Optic neuritis | Eye disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Initial insomnia | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Muscular weakness | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Motor dysfunction | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (15.1) | Non-systematic Assessment |
|
According the contract he signed, If results should have been edited, the Principal Investigators (PI) should have been obtained the agreement from the sponsor 90 days before the publication. The PI was not allowed to communicate within a public way the information on the study without having obtained the sponsor's agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068576 | Interferon beta-1b |
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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