BAY86-5046 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎43

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
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PhaseCountries
1EUCTR2017-001176-31-CZ
(EUCTR)
07/12/201703/08/2017A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Bayer AG,NULLNot RecruitingFemale: yes
Male: yes
300Phase 4Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
2EUCTR2017-001176-31-GB
(EUCTR)
06/11/201721/07/2017 A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Bayer AG,NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesPortugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
3EUCTR2017-001176-31-DK
(EUCTR)
25/10/201714/08/2017A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Bayer AG,NULLNot RecruitingFemale: yes
Male: yes
300Phase 4Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
4NCT03134573
(ClinicalTrials.gov)
September 15, 201726/4/2017Medication Usage and Patient Reported Outcomes Evaluation Via myBETAapp in Patients With Multiple Sclerosis Treated With Betaferon: a Pilot StudyPROmyBETAapp: Ascertaining Medication Usage & Documentation of Patient Reported Outcomes Utilizing the myBETAapp® in Patients With Multiple Sclerosis Treated With Betaferon®: a Pilot StudyMultiple SclerosisDrug: Interferon beta-1b (Betaferon, BAY86-5046);Device: Betaconnect auto-injector;Device: myBETAappBayerNULLCompleted18 YearsN/AAll96Germany
5EUCTR2017-001176-31-FI
(EUCTR)
14/09/201710/08/2017A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Bayer AG,NULLNot RecruitingFemale: yes
Male: yes
300Phase 4Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
6EUCTR2017-001176-31-AT
(EUCTR)
07/09/201726/07/2017A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Bayer AG,NULLNot RecruitingFemale: yes
Male: yes
300Phase 4Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
7NCT02749396
(ClinicalTrials.gov)
May 2, 201620/4/2016EPID Multiple Sclerosis Pregnancy StudyPregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon ß - a Register-based Study in the Nordic CountriesMultiple SclerosisDrug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG;Drug: Extavia (interferon beta-1b), Novartis Pharma AG;Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd;Drug: Plegridy (peginterferon beta-1a), Biogen Idec Ltd;Drug: Avonex (interferon beta-1a), Biogen Idec Ltd;Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046);Other: No MSDMDs therapy (control)BayerEPID Research;Biogen;Merck Serono Europe Ltd;Novartis PharmaceuticalsCompletedN/AN/AFemale2089Finland
8NCT02652091
(ClinicalTrials.gov)
February 5, 20165/1/2016Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient SatisfactionImpact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient SatisfactionMultiple Sclerosis, Relapsing-RemittingDrug: Interferon beta-1b (Betaseron, BAY86-5046);Device: BETACONNECT deviceBayerNULLCompleted18 YearsN/AAll146United States
9NCT02486640
(ClinicalTrials.gov)
September 8, 201515/6/2015Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With BetaferonBETAPREDICT - MS Patients Treated With BETAferon®: PREDICTors of Treatment AdherenceMultiple SclerosisDrug: Interferon beta-1b (Betaferon, BAY86-5046);Device: Betaconnect AutoinjectorBayerNULLCompleted18 YearsN/AAll162Germany
10NCT02121444
(ClinicalTrials.gov)
June 23, 201422/4/2014BAY86-5046 (Betaseron), Non Interventional StudiesBETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®Multiple SclerosisDrug: Interferon beta-1b (Betaferon, BAY 86-5046);Device: BETACONNECT auto-injector.BayerNULLCompleted18 YearsN/AAll151N/AGermany
11EUCTR2012-005262-35-GB
(EUCTR)
14/08/201311/06/2013A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 Clinically isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: Recombinant interferon beta-1b
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
468 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesPortugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
12EUCTR2012-005262-35-IT
(EUCTR)
14/08/201325/06/2013A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 Clinically isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: Recombinant interferon beta-1b
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
468Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
13NCT01706055
(ClinicalTrials.gov)
September 20127/9/2012Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE)Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon®Multiple SclerosisBiological: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 YearsN/AAll629N/APoland
14NCT01491100
(ClinicalTrials.gov)
April 30, 201212/12/2011Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple SclerosisStudy Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®Multiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted12 Years70 YearsAll1085Albania;Algeria;Argentina;Belgium;Czechia;Egypt;France;Germany;Greece;Hungary;Israel;Kazakhstan;Netherlands;Portugal;Saudi Arabia;Tunisia;Turkey;Bosnia and Herzegovina;Czech Republic;Jordan;Lebanon;Mexico;Poland;Syrian Arab Republic
15NCT01436838
(ClinicalTrials.gov)
March 201219/9/2011China Betaferon Adherence, Coping and Nurse Support StudyProspective Study of Betaferon in Adherence, Coping and Nurse Support in Patients of Chinese Origin With Multiple SclerosisMultiple Sclerosis, Chronic ProgressiveDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 Years75 YearsBoth110N/AChina
16NCT01071694
(ClinicalTrials.gov)
January 201118/2/2010QOLBET Quality Of Life in Patients With Early Relapsing-remitting Multiple Sclerosis Treated With BETaferon® in KoreaQOLBET Quality Of Life in Patients With Early Relapsing-remitting Multiple Sclerosis Treated With BETaferon® in KoreaMultiple Sclerosis, Relapsing-RemittingDrug: Interferon beta 1-b (Betaferon/Betaseron, BAY86-5046)BayerNULLWithdrawn18 YearsN/ABoth0N/AKorea, Republic of
17NCT01354665
(ClinicalTrials.gov)
May 201016/5/2011Depression and Fatigue in MS Patients Treated With Betaferon.The Short-term Effect of Immunomodulatory Treatment With Interferon Beta-1b (Betaferon) on Fatigue and Depression in First-time Treated Patients With Relapsing-remitting Multiple Sclerosis.Multiple SclerosisBiological: Interferon beta-1b (Betaferon, BAY86-5046)BayerNULLCompleted18 YearsN/ABoth567N/APoland
18NCT01076595
(ClinicalTrials.gov)
May 201025/2/2010Prospective, Multicenter Non Interventional Study to Evaluate Adherence to Betaferon Over a 2 Years PeriodProspective Multicenter, Non Interventional Study to Evaluate the Patient's Characteristics Associated With Adherence to Treatment Regimen by Betaferon in the BetaPlus ProgramMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 YearsN/ABoth73N/AFrance
19NCT01031459
(ClinicalTrials.gov)
January 20108/12/2009Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial.An Observational 20-year, Cross-sectional, Long-term Follow up of the Patient Cohort Enrolled in the Pivotal Study of Betaseron® (Interferon Beta-1b) in Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: Betaseron (Interferon beta-1b, BAY86-5046)BayerNULLCompleted18 YearsN/ABoth176N/AUnited States;Canada
20NCT00963833
(ClinicalTrials.gov)
December 17, 200921/8/2009Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple SclerosisStudy Evaluating Betaferons® Safety and Tolerability In Pediatric Patients With Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted12 Years16 YearsAll68N/AAustria;Belgium;Finland;Germany;Israel;United Kingdom;Italy;Portugal
21NCT00902135
(ClinicalTrials.gov)
May 200913/5/2009Injection Management With Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH)Betaferon® Injection Management: Non-interventional Study on Personal Digital Assistant (PDA)Supported Effects on Adherence to a Long-term Injection Therapy (BETAPATH)Relapsing-Remitting Multiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 YearsN/ABoth702N/AGermany
22NCT03408093
(ClinicalTrials.gov)
February 3, 20098/1/2018Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1bCross-sectional Retrospective Study of Therapeutic Compliance in Patients With Multiple Sclerosis Treated With Interferon Beta-1bMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 Years100 YearsAll120NULL
23NCT01184833
(ClinicalTrials.gov)
September 200818/8/2010Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple SclerosisEvaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 YearsN/ABoth852N/APoland
24NCT03577977
(ClinicalTrials.gov)
June 1, 200825/6/2018Betaferon Use in Children and Adolescents With Multiple SclerosisRetrospective Data Collection on Betaferon Use in Children and Adolescents With Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, Betaferon, BAY86-5046)BayerNULLCompletedN/A18 YearsAll70Russian Federation
25NCT00787657
(ClinicalTrials.gov)
June 20086/11/2008Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon TreatmentBetaferon Prospective Study on Adherence, Coping and Nursing SupportRelapsing Remitting Multiple Sclerosis (RRMS)Drug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted12 YearsN/ABoth1723N/AArgentina;Bahrain;Belgium;Bosnia and Herzegovina;Canada;China;Colombia;Czech Republic;Egypt;Estonia;France;Germany;Iran, Islamic Republic of;Israel;Italy;Jordan;Korea, Republic of;Kuwait;Lebanon;Libyan Arab Jamahiriya;Mexico;Netherlands;New Zealand;Norway;Pakistan;Portugal;Saudi Arabia;Singapore;Slovakia;Slovenia;Sweden;Syrian Arab Republic;Taiwan;United Arab Emirates;United Kingdom;Venezuela
26NCT01414816
(ClinicalTrials.gov)
April 200813/7/2011Betaferon® Regulatory Post-Marketing SurveillanceBetaferon® Regulatory Post-Marketing SurveillanceMultiple Sclerosis;Clinically Isolated SystemDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted12 YearsN/ABoth355N/AKorea, Republic of
27NCT00873340
(ClinicalTrials.gov)
October 200731/3/2009Physical Disability in Patients Treated With BetaferonPhysical Disability Observational Study in Patients Treated With Betaferon in Daily PracticeMultiple SclerosisDrug: Interferon-1beta (Betaseron, BAY86-5046)BayerNULLCompleted18 YearsN/ABoth83N/AColombia
28NCT00544037
(ClinicalTrials.gov)
September 200715/10/2007BENEFIT Extension StudyExtension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted23 Years50 YearsBoth283N/AAustria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Slovenia;Spain;Sweden;Switzerland;Portugal;United Kingdom
29NCT01235455
(ClinicalTrials.gov)
August 20074/11/2010Portuguese Observational Survey to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon by Using Elements of the BetaPlus Program - Nurse Support, Auto-injectorsPortuguese BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis (MS) After Conversion to Betaferon by Using Elements of the BetaPlus ProgramRelapsing Remitting Multiple Sclerosis (RRMS);Secondary Progressive Multiple Sclerosis (SPMS)Drug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 YearsN/ABoth10N/APortugal
30NCT01158183
(ClinicalTrials.gov)
July 20077/7/2010Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple SclerosisReal-World Betaseron® Outcomes Study (ROBUST): A Twelve-month, US Prospective, Observational, Open-label, Single-arm, Multi-center Outcomes Study of Interferon ß-1b (Betaseron®) Given Every Other Day for Relapsing Forms of Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: BAY86-5046_Interferon-beta-1bBayerNULLCompleted18 Years65 YearsBoth226N/AUnited States
31NCT00459667
(ClinicalTrials.gov)
May 200711/4/2007BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New DoseInternational, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µgMultiple Sclerosis, Relapsing-RemittingDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 Years55 YearsAll1420Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Slovenia;Spain;Sweden;Switzerland;Ukraine
32NCT00928967
(ClinicalTrials.gov)
May 200723/6/2009Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis PatientsProspective Multicenter, Non-interventional Study to Evaluate the Impact of the Introduction of Interferon Beta-1 b Treatment on Daily Life Activities in Patients at High Risk of Developing Multiple Sclerosis After a First Clinical Demyelinating Event or Having Received a Confirmed Diagnosis of RRMSMultiple SclerosisDrug: Interferon beta-1b, (Betaseron BAY86-5046)BayerNULLCompleted18 YearsN/ABoth67N/AFrance
33NCT00461396
(ClinicalTrials.gov)
May 200717/4/2007Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early Multiple Sclerosis (MS) Treatment With BetaseronOpen-Label, Multicenter, Observational, Phase IV Study to Evaluate the Adherence to Treatment With 250mcg (8MIU) IFNB-1b (Betaseron®) Given Subcutaneous Every Other Day Over a Period of up to 12 Months in Patients With a First Clinical Demyelinating Event Suggestive of Multiple Sclerosis and Patients With Onset of Relapsing-Remitting Multiple Sclerosis (RRMS) Within the Past 12 MonthsMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Interferon-1beta (Betaseron, BAY86-5046)BayerNULLCompleted18 Years50 YearsBoth104Phase 4United States
34NCT00370071
(ClinicalTrials.gov)
November 200629/8/2006Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple SclerosisOpen Label Study to Evaluate the Effect, Safety and Tolerability of 250µg (8 MIU) Interferon Beta 1b (Betaferon) Given Subcutaneously Every Other Day (for 24 Weeks) in Patients of Chinese Origin With Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted16 Years55 YearsAll39Phase 3China
35NCT00882453
(ClinicalTrials.gov)
August 200615/4/2009Physical Activity and Fatigue in Early Multiple Sclerosis (MS)Betaferon Treatment and Exercise Data Gathering IN Early MSMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 YearsN/ABoth1739N/AAustralia;Austria;Bahrain;Belgium;Canada;Colombia;Czech Republic;Denmark;Egypt;France;Germany;Greece;Indonesia;Israel;Italy;Jordan;Kazakhstan;Korea, Republic of;Kuwait;Lebanon;Mexico;Netherlands;Norway;Oman;Portugal;Slovenia;Spain;Sweden;Switzerland;Taiwan;Thailand;United Arab Emirates;United Kingdom
36NCT00313976
(ClinicalTrials.gov)
November 200511/4/2006Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)BayerNULLWithdrawn18 YearsN/ABoth0Phase 3Denmark;Sweden
37NCT00206635
(ClinicalTrials.gov)
January 20059/9/2005Betaseron 16-Year Long-Term Follow-Up (LTF) in Patients With Relapsing-Remitting Multiple SclerosisA Long-term Follow up of Patients Enrolled in the Pivotal Study of Betaseron® (Interferon Beta 1b) in Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted33 YearsN/ABoth432N/AUnited States;Canada;United Kingdom
38NCT01233245
(ClinicalTrials.gov)
April 200414/10/2010BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus ProgramBetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus ProgramRelapsing Remitting MS (RRMS);Secondary Progressive MS (SPMS)Drug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 YearsN/ABoth1077N/ACzech Republic;France;Germany;Iran, Islamic Republic of;Israel;Italy;Jordan;Korea, Republic of;Lebanon;Netherlands;Portugal;Saudi Arabia;Spain;Taiwan;Turkey
39NCT00099502
(ClinicalTrials.gov)
November 200315/12/2004BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) PatientsInternational, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily.Multiple Sclerosis, Relapsing-RemittingDrug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046);Drug: CopaxoneBayerNULLCompleted18 Years55 YearsBoth2244Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Slovenia;Spain;Sweden;Switzerland;Ukraine
40NCT00235989
(ClinicalTrials.gov)
June 200310/10/2005Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple SclerosisAn Open-label Extension Study of the Double-blind, Randomized, Parallel Group, Multicenter Phase 2 Study 307000A to Further Evaluate the Safety and Tolerability of Betaseron® 500 mcg Subcutaneously Every Other Day and Betaseron® 250 mcg Subcutaneously Every Other Day in Patients With Relapsing-remitting Multiple Sclerosis (RRMS)Multiple Sclerosis, Relapsing-RemittingDrug: Interferon beta 1b (Betaseron, BAY86-5046)BayerNULLCompleted18 Years55 YearsAll63Phase 2United States
41NCT00893217
(ClinicalTrials.gov)
November 20024/5/2009BEYOND Pilot StudyDouble-blind, Randomized, Parallel Group, Multicenter Study of the Safety and Tolerability of Betaseron 500 Mcg Subcutaneously Every Other Day and Betaseron 250 Mcg Subcutaneously Every Other Day for at Least 12 Weeks in Patients With RRMSMultiple Sclerosis;Relapsing-RemittingDrug: Betaseron (Interferon beta-1b, BAY86-5046)BayerNULLCompleted18 Years55 YearsBoth71Phase 2United States
42NCT00185211
(ClinicalTrials.gov)
August 20029/9/2005BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up StudyOpen-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months.Multiple SclerosisDrug: Interferon beta-1b (Betaseron, BAY86-5046)BayerNULLCompleted18 Years48 YearsAll468Phase 3Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom
43EUCTR2014-004613-93-Outside-EU/EEA
(EUCTR)
12/01/2015Open label study to evaluate effect, safety and tolerability of Betaferon standard dose of 250µg in patients of Chinese origin with multiple sclerosisOpen label study to evaluate the effect, safety and tolerability of 250µg (8 MIU) interferon beta 1b (Betaferon) given subcutaneously every other day (for 24 weeks) in patients of Chinese origin with multiple sclerosis Multiple sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaseron
Product Code: BAY86-5046
INN or Proposed INN: INTERFERON BETA-1B
Bayer HealthCare AGNULLNAFemale: yes
Male: yes
35China