BETAFERON ( 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90

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 266 - 標的パスウェイ数 : 240
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03808142
(ClinicalTrials.gov)
February 20, 201910/1/2019PROmyBETAappGame: a Study to Learn More About the Medication Usage & Patient Reported Outcomes Via the myBETAapp and to Find Out More About the Usage of Game Principles and Game Design Elements (Gamification) in Medical Care of Patients With Multiple Sclerosis Treated With BetaferonPROmyBETAappGame: Ascertaining Medication Usage & Patient Reported Outcomes Via the myBETAapp and Exploring Gamification in Patients With Multiple Sclerosis Treated With BetaferonMultiple SclerosisOther: myBETAapp;Other: PEAK;Drug: Betaferon, BAY86-5046;Device: BETACONNECTBayerNULLCompleted18 YearsN/AAll79Germany
2EUCTR2018-001292-21-FR
(EUCTR)
27/07/201805/06/2018Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 yearsDisease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years Secondary Progressive Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AVONEX
Product Name: BETAFERON
Product Code: L03 AB 08
Product Name: EXTAVIA
Product Name: REBIF
Product Name: PLEDIGRY
Product Name: COPAXONE
Product Name: AUBAGIO
Product Name: TECFIDERA
Product Name: GILENYA
Product Name: TYSABRI
Product Name: IMUREL
Product Name: NOVATREX
Product Name: CELLCEPT
Product Name: ENDOXAN
CHU de RennesNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
3EUCTR2017-001176-31-PT
(EUCTR)
12/03/201801/03/2018A 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: 20.1;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
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;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Norway;Sweden
4EUCTR2016-004819-12-IT
(EUCTR)
10/01/201820/01/2022Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patientsDiscontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients: a multicentre randomized clinical trial. - Full Responders Relapsing-Remitting multiple sclerosis (RR-MS),
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: BETAFERON - 15 FLACONCINI 0.25 MG + 15 FLACONCINI 2 ML
Product Name: Interferone Beta-1B
Product Code: [032166011]
INN or Proposed INN: INTERFERONE BETA 1B
Other descriptive name: Interferon Beta-1B
Trade Name: AVONEX - 30 MCG (6 MILIONI UI) POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 4 FLACONI CON DISPOSITIVO BIOSET + 4 SIRINGHE PRERIEMPITE USO INTRAMUSCOLARE
Product Name: Inteferone Beta-1A
Product Code: [033283045]
INN or Proposed INN: INTERFERON BETA - 1A
Other descriptive name: Interferon Beta 1-A
Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO
Product Name: Glatiramer acetato
Product Code: [035418060]
INN or Proposed INN: GLATIRAMER ACETATO
Other descriptive name: Glatiramer acetate
Trade Name: REBIF - 44 MCG(12 MILIONI UI) -SOLUZ INIETTABILE- USO SOTTOCUTANEO-PENNA PRERIEMPITA 0.5 ML (24 MILIONI UI/ML)12 PENNE PRERIEMPITE
Product Name: Interferon Beta-1a
Product Code: [034091165]
INN or Proposed INN: INTERFERON BETA - 1A
Other descriptive name: Interferon Beta-1a
OSPEDALE SAN RAFFAELENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 4Italy
5EUCTR2017-001176-31-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
6EUCTR2017-001176-31-FR
(EUCTR)
07/12/201716/01/2018 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: 20.1;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
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;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
7EUCTR2017-001176-31-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
8EUCTR2017-001176-31-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
9EUCTR2017-002634-24-SE
(EUCTR)
29/09/201706/07/2017MultipleMS – a study with the aim to accelerate personalised medicine in multiple sclerosis.MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMS Newly diagnosed patients with Clinically Isolated Syndrome (CIS) and multiple sclerosis (MS) -both relapsing remitting and primary progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Gilenya
INN or Proposed INN: FINGOLIMOD
Other descriptive name: FINGOLIMOD
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Extavia
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name:
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Sweden
10EUCTR2017-001176-31-ES
(EUCTR)
20/09/201712/07/2017A 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
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 4Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden;Portugal;Slovenia
11NCT03134573
(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
12EUCTR2017-001176-31-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
13EUCTR2017-001176-31-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
14EUCTR2016-003587-39-SE
(EUCTR)
22/05/201723/03/2017This is a long-term study of the safety, efficacy and patient satisfaction of the drug rituximab in comparison with other immunomodulatory treatments for multiple sclerosis. The study will use a national registry for both retrospective and prospective data retrieval.COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)A prospective long-term cohort study of safety, efficacy and patient’s satisfaction of MS disease modulatory treatments in relapsing-remitting multiple sclerosis - COMparison Between All immunoTherapies for Multiple Sclerosis (COMBAT-MS) Relapsing-remitting multiple sclerosis (RRMS) that has started on their first or second immunomodulatory drug at the earliest 2011-01-01 and at the latest 2018-06-30. The clinical course and response to treatment is thereafter followed until 2021-06-30;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Gilenya
INN or Proposed INN: FINGOLIMOD
Other descriptive name: FINGOLIMOD
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Extavia
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
3700Phase 4Sweden
15EUCTR2016-000434-21-PT
(EUCTR)
14/11/201614/09/2016PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™) Relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Plegridy 125 micrograms
INN or Proposed INN: Peginterferon beta-1a
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Rebif 22 micrograms
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 44 micrograms
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Betaferon 250 microgram/ml
INN or Proposed INN: Recombinant Interferon Beta-1b
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Trade Name: Extavia 250 micrograms/ml
INN or Proposed INN: Recombinant Interferon Beta-1b
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Trade Name: Plegridy 63 micrograms
INN or Proposed INN: Peginterferon beta-1a
Other descriptive name: PEGINTERFERON BETA-1A
Biogen PortugalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 4Portugal
16NCT02486640
(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
17NCT02474134
(ClinicalTrials.gov)
March 201517/3/2015Comparison Study of PF530 and Betaferon in Healthy SubjectsA Phase 1 Double-Blind, Randomised, Two-Treatment Cross-over Study Comparing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF530 and Betaferon Administered by Subcutaneous Injection in Healthy Adult VolunteersMultiple SclerosisDrug: Interferon beta-1b (PF530, Betaferon)Pfenex, IncNULLCompleted18 Years50 YearsBoth12Phase 1Australia
18EUCTR2012-005086-12-PL
(EUCTR)
07/01/201516/09/2014Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
234Phase 3Serbia;Hungary;Poland;Ukraine;Austria;Russian Federation;Bulgaria;Germany
19NCT02247310
(ClinicalTrials.gov)
October 20, 201419/9/2014BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With BetaferonBETAEVAL_Global- The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®Multiple Sclerosis, Relapsing RemittingDrug: Interferon beta-1b (Betaferon®, BAY 86-5046);Device: BETACONNECTBayerNULLCompletedN/AN/AAll498N/AAustria;Belgium;Bosnia and Herzegovina;Croatia;Czechia;France;Greece;Hungary;Italy;Spain;Switzerland;Czech Republic;Netherlands
20NCT02121444
(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
21EUCTR2012-005450-30-SE
(EUCTR)
27/01/201410/12/2013Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk of immunization in multiple sclerosis patients on interferon-beta treatmentAnti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk of immunization in multiple sclerosis patients on interferon-beta treatment - ABIRISK Development of neutralising antibodies against Interferon-beta in the treatment of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Avonex
Trade Name: Rebif
Trade Name: Betaferon
Trade Name: Extavia
Medizinische Universität InnsbruckNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Austria;Sweden
22EUCTR2012-005450-30-AT
(EUCTR)
08/01/201411/11/2013Investigation of neutralising antibodies against interferon-beta in patients with multiple sclerosis, in order to find markers to predict the development of these antibodies and minimize the risk of ineffective therapyAnti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk of immunization in multiple sclerosis patients on interferon-beta treatment - ABIRISK Development of neutralising antibodies against Interferon-beta in the treatment of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Avonex
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Betaferon
INN or Proposed INN: Interferon-beta 1b
Other descriptive name: INTERFERON BETA-1B
Trade Name: Extavia
INN or Proposed INN: Interferon-beta 1b
Other descriptive name: INTERFERON BETA-1B
Trade Name: Rebif
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: INTERFERON BETA-1A
Medizinische Universität InnsbruckNULLNot RecruitingFemale: yes
Male: yes
100Phase 4Austria;Sweden
23EUCTR2013-004626-28-FI
(EUCTR)
20/12/201320/11/2013Does targeting of S1P receptors reduce microglial activation in multiple sclerosis?Does targeting of S1P receptors reduce microglial activation in multiple sclerosis? Multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Trade Name: REBIF
Product Name: beetainterferoni -1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Gilenya
Product Name: Fingolimodi
Other descriptive name: FINGOLIMOD
Trade Name: Avonex
Trade Name: Betaferon
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Lemtrada
Other descriptive name: ALEMTUZUMAB
Turku University HospitalNULLNot RecruitingFemale: yes
Male: yes
60Phase 4Finland
24EUCTR2012-005086-12-BG
(EUCTR)
14/11/201319/08/2013Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing multiple sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
Product Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Trade Name: Extavia 250 microgram/ml
Product Name: Extavia 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1a
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
234Phase 3Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
25EUCTR2012-005086-12-DE
(EUCTR)
12/11/201301/07/2013Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
Product Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Trade Name: Extavia 250 microgram/ml
Product Name: Extavia 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1a
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
216Phase 3Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
26EUCTR2012-005262-35-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
27EUCTR2012-005262-35-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
28EUCTR2012-005086-12-HU
(EUCTR)
31/07/201318/06/2013Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
Product Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Trade Name: Extavia 250 microgram/ml
Product Name: Extavia 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1a
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
216Phase 3Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
29EUCTR2012-005262-35-AT
(EUCTR)
19/07/201302/04/2013A 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
INN or Proposed INN: Recombinant interferon beta-1b
Bayer HealthCare AGNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
30EUCTR2012-005262-35-SI
(EUCTR)
10/07/201310/07/2013A 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
INN or Proposed INN: Recombinant interferon beta-1b
Bayer HealthCare AGNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
31EUCTR2012-005086-12-AT
(EUCTR)
05/07/201308/05/2013Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing multiple sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
Product Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Trade Name: Extavia 250 microgram/ml
Product Name: Extavia 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1a
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
216Phase 3Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
32EUCTR2012-005262-35-ES
(EUCTR)
28/06/201313/06/2013A 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
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;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
33EUCTR2012-005262-35-FI
(EUCTR)
18/06/201325/04/2013A 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: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0;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
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;Norway;Netherlands;Germany;Sweden
34EUCTR2012-005262-35-CZ
(EUCTR)
13/06/201326/03/2013A 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: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0;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
INN or Proposed INN: Recombinant interferon beta-1b
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
468Phase 4Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
35EUCTR2012-004040-30-AT
(EUCTR)
24/05/201312/03/2013Natalizumab de-escalation to interferon-beta-1b in patients withrelapsing-remitting multiple sclerosis: A multicenter studyNatalizumab de-escalation to interferon-beta-1b in patients withrelapsing-remitting multiple sclerosis: A multicenter study relapse-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: BETAFERON® (interferon beta-1b)
Product Name: Betaferon
INN or Proposed INN: Betaferon
Other descriptive name: INTERFERON BETA-1B
Ospedale Regionale di LuganoNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Austria;Switzerland
36NCT01766063
(ClinicalTrials.gov)
December 6, 20127/12/2012Investigating the Relationship Between Sleep, Quality of Life,Other Disorders and Therapies in MS Patients on BetaferonBETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS PatientsMultiple SclerosisDrug: Interferon beta-1b (Betaferon, BAY 86-5046)BayerNULLCompleted18 YearsN/AAll138Germany
37NCT01706055
(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
38NCT01491100
(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
39EUCTR2011-002683-24-BG
(EUCTR)
17/04/201210/01/2012A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosisA phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis relapsing forms of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: NU100
INN or Proposed INN: n/a
Other descriptive name: n/a
Trade Name: Betaferon
Product Name: Betaferon
INN or Proposed INN: n/a
Other descriptive name: INTERFERON BETA-1B
Nuron Biotech, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Phase 3Belarus;Hungary;Spain;Poland;Ukraine;Lebanon;Croatia;Georgia;Russian Federation;Bulgaria;Italy
40EUCTR2011-002683-24-HU
(EUCTR)
02/03/201215/12/2011A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosisA phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis relapsing forms of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: NU100
INN or Proposed INN: n/a
Other descriptive name: n/a
Trade Name: Betaferon
Product Name: Betaferon
INN or Proposed INN: n/a
Other descriptive name: INTERFERON BETA-1B
Nuron Biotech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3Belarus;Hungary;Spain;Poland;Ukraine;Lebanon;Croatia;Bulgaria;Georgia;Russian Federation;Italy
41NCT01436838
(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
42EUCTR2011-002683-24-IT
(EUCTR)
14/02/201223/12/2011A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosisA phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis relapsing forms of multiple sclerosis
MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: NU100
Trade Name: Betaferon
Other descriptive name: INTERFERON BETA-1B
NURON BIOTECH INC.NULLNot RecruitingFemale: yes
Male: yes
500Phase 3Belarus;Hungary;Spain;Bulgaria;Russian Federation;Italy
43EUCTR2011-002683-24-ES
(EUCTR)
30/01/201214/11/2011A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosisA phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU100 in patients with relapsing forms of multiple sclerosis Relapsing forms of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: NU100
Trade Name: Betaferon
Product Name: Betaferon
Other descriptive name: INTERFERON BETA-1B
Nuron Biotech, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3Hungary;Russian Federation;Ukraine;Belarus;Georgia;Bulgaria;Spain;Italy;Croatia;Poland
44EUCTR2011-001956-12-CZ
(EUCTR)
25/05/201104/05/2011Biological Efficacy of Interferon ß Therapy in Patients with Multiple SclerosisMonitoring of MxA mRNA Expression as a Marker of Rresponse to Interferon ß Therapy in Patients with Multiple Sclerosis. To correlate bioactivity of IFNß reflected by level of MxA expression and clinical course of MS To measure expression of MxA protein in patients treated with IFNß depending on NAbs statusNAbs positive cohorts will be correlated NAbs titer with level of MxA expression, respectively if the MxA decrease is not preceding NAbs positivity. The MxA induction test will be tested.Trade Name: Avonex®
Product Name: Avonex®
Product Code: EU/1/97/033/002
Trade Name: Betaferon®
Product Name: Betaferon®
Product Code: EU/1/95/003/005-010
Trade Name: Rebif 22®
Product Name: Rebif 22®
Product Code: EU/1/98/063/001-003
Trade Name: Rebif 44®
Product Name: Rebif 44®
Product Code: EU/1/98/063/004-006
Trade Name: Extavia®
Product Name: Extavia®
Product Code: EU/1/08/454/001-002, EU/1/08/454/005-007
University Hospital MotolNULLNot RecruitingFemale: yes
Male: yes
Phase 4Czech Republic
45EUCTR2010-023677-19-IT
(EUCTR)
23/03/201110/06/2011Bio-molecular effects of interferon-beta and d-vitamin association - VITAD-2010Bio-molecular effects of interferon-beta and d-vitamin association - VITAD-2010 PATIENT WITH RRMS AND SPMS
MedDRA version: 13.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders
Trade Name: BETAFERON*15CONFEZ 0,25MG/ML+
INN or Proposed INN: Interferon beta-1b
Trade Name: EXTAVIA*SC 15FL 250MCG/ML+15SI
INN or Proposed INN: Interferon beta-1b
Trade Name: DIBASE
INN or Proposed INN: Colecalciferol
AZIENDA OSPEDALIERA S. LUIGI GONZAGANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
46NCT01071694
(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
47NCT01076595
(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
48NCT01354665
(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
49EUCTR2009-016824-29-DK
(EUCTR)
06/04/201025/02/2010REsPons på interferon-Alfa hos InterfeRon-ß-neutraliserende antistof-positive patienter med multipel sklerose - REPAIRREsPons på interferon-Alfa hos InterfeRon-ß-neutraliserende antistof-positive patienter med multipel sklerose - REPAIR Multiple Sclerosis
MedDRA version: 12.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Multiferon
INN or Proposed INN: HUMAN LEUCOCYTE INTERFERON-ALPHA
Other descriptive name: HUMAN LEUCOCYTE INTERFERON-ALPHA
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Dansk Multipel Sclerose CenterNULLNot RecruitingFemale: yes
Male: yes
10Denmark
50NCT01031459
(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
51NCT00963833
(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
52EUCTR2009-013284-19-AT
(EUCTR)
10/12/200923/11/2009Immune tolerance induction in MS patients with neutralizing antibodies against interferon-beta - HINABSImmune tolerance induction in MS patients with neutralizing antibodies against interferon-beta - HINABS multiple sclerosis patients with neutralizing antibodies against interferon-betaTrade Name: Betaferon
Other descriptive name: INTERFERON BETA-1B
Medical University InnsbruckNULLNot RecruitingFemale: yes
Male: yes
Austria
53NCT00902135
(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
54NCT03408093
(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
55NCT00780455
(ClinicalTrials.gov)
October 200828/5/2008Rehabilitation Study in MS PatientsMulticenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon®Multiple Sclerosis, Relapsing-RemittingDrug: Interferon beta-1b, FRP within 15 days after randomization;Drug: Interferon beta-1b, FRP about 6 weeks after randomizationBayerNULLTerminated18 YearsN/AAll4Phase 4France
56NCT01184833
(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
57NCT03577977
(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
58NCT00787657
(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
59NCT01414816
(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
60NCT00873340
(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
61NCT01235455
(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
62EUCTR2006-005270-47-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 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
63EUCTR2006-005270-47-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 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
64EUCTR2006-005270-47-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 AGNULLNot RecruitingFemale: yes
Male: yes
1880Phase 3Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
65EUCTR2006-005270-47-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 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
66EUCTR2006-005270-47-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 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
67NCT00459667
(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
68EUCTR2006-005270-47-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
Trade 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 Recruiting Female: yes
Male: yes
1880 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
69EUCTR2006-005270-47-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 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
70EUCTR2006-005270-47-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 3Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
71EUCTR2006-005270-47-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 RecidivanteTrade Name: Betaferon 250 microgramos
INN or Proposed INN: Interferon beta 1b
Product Name: Betaferon 500 µg
Product Code: ZK 157046
INN or Proposed INN: Interferon beta 1b
Schering AGNULLNot Recruiting Female: yes
Male: yes
1880 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSlovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
72EUCTR2006-005270-47-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 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
73EUCTR2006-005270-47-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 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece
74EUCTR2006-005270-47-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 3Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Germany;Latvia;Netherlands;Sweden
75EUCTR2006-005270-47-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 3Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden
76NCT00370071
(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
77EUCTR2005-005751-18-GB
(EUCTR)
07/09/200617/02/2006A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy StudyA multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system of unknown aetiology. It is the commonest cause of disability in young adults. The prevalence in the UK is approximately 125/100,000 of the population with an annual incidence of 6/100,000. Approximately 80,000 individuals are affected with MS in the UK.Trade Name: Rebif 44
Product Name: Rebif 44
Product Code: Interferon beta 1a
INN or Proposed INN: Interferon beta 1a
Trade Name: Rebif 22
Product Name: Rebif 22
Product Code: Interferon beta 1a
INN or Proposed INN: Interferon beta 1a
Product Name: Betaferon 500mcg
Product Code: Betaferon 500mcg
INN or Proposed INN: Interferon beta 1b
UCL Biomedicine R&D UnitNULLNot RecruitingFemale: yes
Male: yes
100United Kingdom
78EUCTR2006-004937-13-IT
(EUCTR)
17/08/200604/07/2007multicentee randomized controlled study of azathioprine versus iterferon beta in relapsing remitting multiple sclerosis - M.A.I.N. trialmulticentee randomized controlled study of azathioprine versus iterferon beta in relapsing remitting multiple sclerosis - M.A.I.N. trial patients with relapsing remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: AZATIOPRINA HEX. 50CPR 50MG BL
INN or Proposed INN: Azathioprine
Trade Name: REBIF SC 12SIR 6000000UI 22MCG
INN or Proposed INN: Interferon beta-1a
Trade Name: BETAFERON SC 15F 0,25MG 15SIR
INN or Proposed INN: Interferon beta-1b
Trade Name: REBIF SC 12SIR 12000000UI44MCG
INN or Proposed INN: Interferon beta-1a
Trade Name: AVONEX IM 4SIR 30MCG/0,5ML 4AG
INN or Proposed INN: Interferon beta-1a
Universita di FirenzeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
79NCT00882453
(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
80EUCTR2005-001540-23-SE
(EUCTR)
03/03/200612/09/2005A Scandinavian, randomized, rater-blinded study of single and double-dose (2x250 mcg e.o.d.) Betaferon in patients with early secondary progressive multiple sclerosis. - BECAUSE - Betaferon in Early SPMS - SCAndinavian study on USE of double doseA Scandinavian, randomized, rater-blinded study of single and double-dose (2x250 mcg e.o.d.) Betaferon in patients with early secondary progressive multiple sclerosis. - BECAUSE - Betaferon in Early SPMS - SCAndinavian study on USE of double dose Early Secondary Progressive Multiple SclerosisTrade Name: Betaferon
Product Name: Betaferon
Trade Name: Betaferon
Product Name: Betaferon
Schering Nordiska ABNULLNot RecruitingFemale: yes
Male: yes
160Denmark;Sweden
81NCT00317941
(ClinicalTrials.gov)
March 200624/4/2006Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or RebifThe AVANTAGE Study - A Randomized, Multicenter, Phase IV, Open-label Prospective Study Comparing Injection Site Reaction and Injection Site Pain in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) or After a First Demyelinating Event Suggestive of MS Newly Started on Interferon Beta-1b (Betaferon®) or Interferon Beta-1a (Rebif®).Relapsing-remitting Multiple SclerosisDrug: Betaferon/Betaseron;Drug: RebifBayerNULLCompleted18 Years55 YearsAll220Phase 4France
82EUCTR2005-005211-21-FI
(EUCTR)
17/01/200607/12/2005A long term follow up of relapsing remitting multiple sclerosis patients who have been treated with intereron beta -1b (Betaferon) at least 5 yearsA long term follow up of relapsing remitting multiple sclerosis patients who have been treated with intereron beta -1b (Betaferon) at least 5 years Remitting relapsing multiple sclerosis (RRMS) is one of the most common diseases of the central nervous system. The cause of MS is not yet known but it is a result of damage to myelin. Symptoms vary widely and include blurred vision, weak limbs, tingling sensations, unsteadiness and fatigue.Trade Name: Betaferon
Product Name: Betaferon
INN or Proposed INN: Beta-1b interferoni
Schering OyNULLNot RecruitingFemale: yes
Male: yes
80Finland
83EUCTR2005-001540-23-DK
(EUCTR)
15/12/200520/10/2005A Scandinavian, randomized, rater-blinded study of single and double-dose (2x250 mcg e.o.d.) Betaferon in patients with early secondary progressive multiple sclerosis. - BECAUSE - Betaferon in Early SPMS - SCAndinavian study on USE of double doseA Scandinavian, randomized, rater-blinded study of single and double-dose (2x250 mcg e.o.d.) Betaferon in patients with early secondary progressive multiple sclerosis. - BECAUSE - Betaferon in Early SPMS - SCAndinavian study on USE of double dose Early Secondary Progressive Multiple SclerosisProduct Name: Betaferon
Product Name: Betaferon
Schering Nordiska ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Denmark;Sweden
84NCT00313976
(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
85NCT01233245
(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
86NCT00099502
(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
87NCT00206648
(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
88NCT00185211
(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
89EUCTR2014-004613-93-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
90EUCTR2006-005270-47-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 3Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece