13. 多発性硬化症/視神経脊髄炎
[臨床試験数:3,050,薬物数:2,147(DrugBank:348),標的遺伝子数:244,標的パスウェイ数:228

Searched query = "Multiple sclerosis/Neuromyelitis optica", "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
53 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04356339
(ClinicalTrials.gov)
November 15, 202019/4/2020US PROmyBETAapp2.0: A Study to Learn More About the Medication Usage and Patient Reported Outcomes Via the myBETAapp in Medical Care of Patients With Multiple Sclerosis Treated With BETASERON Using BETACONNECT AutoinjectorUS PROmyBETAapp2.0: Ascertaining Medication Usage and Patient-reported Outcomes (PROs) Via the myBETAapp™ in Patients With Multiple Sclerosis Treated With BETASERON® Using BETACONNECT™ AutoinjectorMultiple SclerosisDrug: Interferon-beta-1b (BETASERON, BAY 86-5046)BayerNULLNot yet recruiting18 YearsN/AAll200United States
2NCT02749396
(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
3NCT02652091
(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
4NCT02121444
(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
5NCT01706055
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT01491100
(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
7NCT01436838
(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
8NCT01076595
(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
9NCT01031459
(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
10NCT00963833
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT01049451
(ClinicalTrials.gov)
November 200913/1/2010Pulse ACTH vs. MP for MSComparison of Monthly Pulse ACTH (Acthar Gel) Therapy With Methylprednisolone (MP, Solumedrol) for Long-Term Treatment of Multiple Sclerosis (MS) as an Add on Therapy to Beta-interferons (Avonex, Betaseron or Rebif)Multiple SclerosisDrug: ACTH;Drug: MethylprednisoloneUniversity of Southern CaliforniaNULLCompleted18 Years65 YearsAll23Phase 1United States
12NCT00902135
(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
13NCT03408093
(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
14NCT01184833
(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
15NCT03577977
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT00787657
(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
17NCT01414816
(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
18NCT00873340
(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
19NCT00544037
(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
20NCT01235455
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2006-005270-47-GR
(EUCTR)
03/07/200718/06/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
22NCT01158183
(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
23EUCTR2006-005270-47-IT
(EUCTR)
28/06/200719/07/2007International, multicenter, Phase IIIb study of subcutaneous every-other- day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind betaseron/Betaferon 250 ?g or 500 ?g or open-label Betaseron/Betaferon 250 ?g and (Phase B) open-label Betaseron/Betaferon 500 ?g - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other- day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind betaseron/Betaferon 250 ?g or 500 ?g or open-label Betaseron/Betaferon 250 ?g and (Phase B) open-label Betaseron/Betaferon 500 ?g - Beyond Follow-up Relapsing multiple sclerosis
MedDRA version: 6.1;Level: PT;Classification code 10028245
Trade Name: BETAFERON 250 mcg
INN or Proposed INN: interferon beta-1b
Product Name: BETAFERON 500 mcg
Product Code: ZK 157046
INN or Proposed INN: interferon beta-1b
SCHERINGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
24EUCTR2006-005270-47-FR
(EUCTR)
22/05/200723/01/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Schering AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
25EUCTR2006-005270-47-SI
(EUCTR)
16/05/200704/04/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering PharmaNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2006-005270-47-LV
(EUCTR)
02/05/200703/04/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
27NCT00461396
(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
28NCT00459667
(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
29NCT00928967
(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
30EUCTR2006-005270-47-FI
(EUCTR)
23/04/200719/12/2006 International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Schering AGNULLNot Recruiting Female: yes
Male: yes
1880Phase 3Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2006-005270-47-HU
(EUCTR)
16/04/200709/03/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering PharmaNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
32EUCTR2006-005270-47-BE
(EUCTR)
12/04/200722/12/2006International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bSlovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
33EUCTR2006-005270-47-ES
(EUCTR)
08/04/200705/02/2007 Estudio internacional, multicéntrico, de fase IIIb, sobre el tratamiento en días alternos de pacientes con Esclerosis Múltiple Recidivante con: (Fase A) Betaseron/Betaferon 250 µg ó 500 µg de forma doble ciego o Betaferon 250 µg en régimen abierto (Fase B) Betaseron/Betaferon 500 µg en régimen abierto International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A)double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - BEYOND Follow up Estudio internacional, multicéntrico, de fase IIIb, sobre el tratamiento en días alternos de pacientes con Esclerosis Múltiple Recidivante con: (Fase A) Betaseron/Betaferon 250 µg ó 500 µg de forma doble ciego o Betaferon 250 µg en régimen abierto (Fase B) Betaseron/Betaferon 500 µg en régimen abierto International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A)double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - BEYOND Follow up Esclerosis Múltiple RecidivanteSchering AGNULLNot Recruiting Female: yes
Male: yes
1880Phase 3Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
34EUCTR2006-005270-47-NL
(EUCTR)
02/04/200718/04/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Schering AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
35NCT00468182
(ClinicalTrials.gov)
April 200730/4/2007Modulation of Plasmacytoid Dendritic Cell Function in Multiple SclerosisModulation of Plasmacytoid Dendritic Cell Function in Multiple SclerosisMultiple SclerosisDrug: Interferon-beta 1b (Betaseron)Rutgers, The State University of New JerseyBayerCompleted18 Years60 YearsBoth24United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2006-005270-47-SE
(EUCTR)
28/02/200702/02/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer AB, Bayer Health Care, Bayer Schering PharmaNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
37EUCTR2006-005270-47-AT
(EUCTR)
22/02/200731/01/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Schering AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bSlovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Germany;Latvia;Netherlands;Sweden
38EUCTR2006-005270-47-IE
(EUCTR)
16/02/200710/01/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - Beyond Follow-up Relapsing Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Betaferon 250mcg
Product Name: Betaferon 500mcg
Product Code: ZK 157046
Schering AGNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3bSlovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
39NCT00428584
(ClinicalTrials.gov)
December 200629/1/2007RNF and Betaseron® Tolerability StudyA Randomized, Multicenter, Two Arm, Open Label, Twelve Week Phase IIIb Study to Evaluate the Tolerability of Rebif (New Formulation) (IFN Beta-1a) and Betaseron (IFN Beta-1b) in IFN-naive Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Followed by a Single Arm, Eighty-two Week Minimum, Rebif (New Formulation) Only Safety ExtensionRelapsing Remitting Multiple Sclerosis (RRMS)Drug: New Formulation of rebif - human interferon beta-1a;Drug: Interferon beta -1bEMD SeronoPfizerCompleted18 Years60 YearsAll129Phase 3United States
40NCT00370071
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT00882453
(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
42NCT00206635
(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
43NCT00202995
(ClinicalTrials.gov)
July 200413/9/2005Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMSA Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis PatientsRelapsing Remitting Multiple SclerosisDrug: Glatiramer Acetate;Drug: Betaseron;Drug: RebifTeva Pharmaceutical IndustriesNULLTerminated18 Years50 YearsBoth91Phase 4United States;Canada
44NCT01233245
(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
45NCT00099502
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT00235989
(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
47NCT00206648
(ClinicalTrials.gov)
March 200313/9/2005An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MSA Randomized, Rater-blinded, Multicenter, Parallel-group Study Comparing the Efficacy and Safety of Betaseron 250 µg Subcutaneously Every Other Day With Avonex 30 µg Intramuscularly Once Per Week in Relapsing-remitting Multiple Sclerosis Patients Previously Treated With AvonexMultiple Sclerosis, Relapsing-RemittingDrug: Betaferon/BetaseronBayerNULLCompleted18 Years60 YearsBoth271Phase 4United States;Canada
48NCT00298662
(ClinicalTrials.gov)
February 20032/3/2006Combination Therapy of Betaseron-Prograf in Multiple SclerosisA Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying AgentsMultiple SclerosisDrug: Interferon beta-1b and TacrolimusClinique de sclérose en plaques et neuromusculaire de l'OutaouaisNULLActive, not recruiting18 Years55 YearsBoth30Phase 2Canada
49NCT00176592
(ClinicalTrials.gov)
January 200313/9/2005Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRIPhase IV, Rater-blinded, Randomized Study, Comparing 250 mg of Betaseron With 20 mg of Copaxone in Patients With the Relapsing-remitting(RR) or CIS Forms of ms Using 3 Tesla(3T) Magnetic Resonance Imaging (MRI) With Triple-dose GadoliniumMultiple SclerosisDrug: Betaseron;Drug: CopaxoneStuart D Cook MDNULLActive, not recruiting18 Years55 YearsBoth93Phase 4United States
50NCT00893217
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT00185211
(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
52EUCTR2006-005270-47-DE
(EUCTR)
09/02/2007International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-upInternational, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up relapsing multiple sclerosisTrade Name: Betaferon 250µg
INN or Proposed INN: Interferon beta-1b
Product Name: Betaferon 500µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta-1b
Bayer Schering PharmaNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3bHungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
53EUCTR2014-004613-93-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