Interferon-beta-1    (DrugBank: Interferon-beta)

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32

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.
32 / 3,050 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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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
2EUCTR2012-004040-30-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
3NCT01701856
(ClinicalTrials.gov)
September 201218/9/2012Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple SclerosisNatalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis: A Swiss Multicenter Study Prospective, Controlled, Single-arm, Open-label, Multi-centre, Phase IV StudyRelapsing-remitting Multiple SclerosisDrug: Interferon beta-1bClaudio GobbiBayerTerminated18 Years70 YearsBoth5Phase 4Switzerland
4EUCTR2010-023023-19-DE
(EUCTR)
04/01/201218/11/2011Studyto compare the efficacy and safety of fingolimod and interferon-beta-1b in patients with mutliple sclerosisA 18-month, open-label, rater-blinded, randomized, multicenter, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod in comparison to interferon beta 1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy treating of cognitive symptoms in relapsing-remitting multiple sclerosis
MedDRA version: 14.1;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: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Extavia
Other descriptive name: INTERFERON BETA-1B
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Extavia
Product Name: Extavia
Product Code: NVF233
Other descriptive name: INTERFERON BETA-1B
Novartis Farma S.p.A.NULLNot RecruitingFemale: yes
Male: yes
Germany;Italy
5NCT01144052
(ClinicalTrials.gov)
June 201011/6/2010Natalizumab De-escalation With Interferon Beta-1bDe-escalation After Natalizumab Treatment With Interferon-beta-1b in Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: interferon beta-1b;Drug: NatalizumabClaudio GobbiOspedale Civico, LuganoCompleted18 Years60 YearsAll19Phase 4Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT01432704
(ClinicalTrials.gov)
March 200816/8/2011Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MSMultiple SclerosisDrug: colecalciferolUniversity of TurkuBayerCompleted18 Years50 YearsBoth70Phase 2;Phase 3NULL
7NCT01339676
(ClinicalTrials.gov)
March 200819/4/2011Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MSMultiple SclerosisDrug: Colecalciferol;Drug: Placebo capsulesUniversity of TurkuNULLActive, not recruiting18 Years55 YearsBoth70Phase 4Finland
8EUCTR2007-001958-99-FI
(EUCTR)
18/12/200707/12/2007Collecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MSCollecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MS Patients with relapsing remitting MS according to the revised Mc Donald's criteria who meet all criteria for inclusion and none criteria of exclusion.
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Dekristol 20000 IE
Product Name: Dekristol
INN or Proposed INN: INN COLECALCIFEROL
Product Name: Placebo Dekristol SGC 20000
Merja Soilu HäninenNULLNot RecruitingFemale: yes
Male: yes
Finland
9NCT01111656
(ClinicalTrials.gov)
March 200715/3/2010Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1bSWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study (SWABIMS Follow Up-study)Relapsing-remitting Multiple SclerosisDrug: Interferon beta-1b group;Drug: Interferon beta-1b/Atorvastatin groupUniversity Hospital Inselspital, BerneViollier AG, Basel, Switzerland;PharmaPart GmbH, Thalwil, SwitzerlandCompleted18 Years67 YearsBoth28Phase 2Switzerland
10NCT00441103
(ClinicalTrials.gov)
December 200626/2/2007A Study to Evaluate Rebif® New Formulation (Interferon-beta-1a) in Relapsing Remitting Multiple SclerosisA Two-arm, Randomized, Double-blind, Control Group-compared, Multicenter, Phase IIIb Study With Monthly MRI and Biomarker Assessments to Evaluate the Efficacy, Safety, and Tolerability of Rebif® New Formulation (IFN Beta-1a) in Subjects With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Rebif® New Formulation (IFN-beta-1a, RNF);Drug: PlaceboMerck KGaANULLCompleted18 Years60 YearsAll180Phase 3Canada;Germany;Italy;Russian Federation;Spain;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2006-000606-23-ES
(EUCTR)
23/11/200615/03/2012?Post-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phasePost-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phase - PASS-PD del escalado de dosis de Rebif Not applicalbe
MedDRA version: 14.1;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: Rebif 22 y 44 mcg
Product Name: Interferon-beta-1a
Other descriptive name: INTERFERON BETA-1A
Merck, S.L.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase -Spain
12EUCTR2004-001286-17-PT
(EUCTR)
08/09/200623/03/2006Exploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosisExploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosis Relapsing-remitting or relapsing secondary progressive multiple sclerosis with high activity
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Mitoxantrone
Product Code: N/A
Fundación Española de Esclerosis Múltiple (FEDEM)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Portugal
13EUCTR2005-005751-18-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
14NCT01134627
(ClinicalTrials.gov)
February 200628/5/2010Minocycline as add-on to Interferon Beta-1a [IFN Beta-1a] (Rebif®) in Relapsing-Remitting Multiple Sclerosis [RRMS]A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline Versus Placebo as Add-on Therapy in Patients Who Are on Treatment With Interferon-beta-1a 44 Mcg Tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Minocycline;Drug: PlaceboMerck KGaANULLTerminated18 Years55 YearsAll305Phase 2Denmark
15NCT00492765
(ClinicalTrials.gov)
February 200625/6/2007Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple SclerosisA Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment IM Administered Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple SclerosisMultiple SclerosisDrug: Interferon-beta-1a;Drug: Simvastatin;Drug: PlaceboBiogen IdecNULLCompleted18 Years55 YearsBoth380Phase 4Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2005-004289-18-FI
(EUCTR)
26/01/200607/11/2005A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline)A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) Relapse Remitting Multiple Sclerosis
MedDRA version: 8.0;Level: PT;Classification code 10063399
Product Name: Minocycline 100 mg Film-coated Tablets
INN or Proposed INN: Minocycline Hydrochloride
Merck ABNULLNot RecruitingFemale: yes
Male: yes
320Finland;Sweden
17EUCTR2005-003930-16-SE
(EUCTR)
19/01/200621/11/2005A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBINA Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a.
MedDRA version: 7.0;Level: PT;Classification code 10028425
Product Name: Simvastatin Alternova
INN or Proposed INN: Simvastatin
Biogen Idec A/SNULLNot RecruitingFemale: yes
Male: yes
380Finland;Sweden
18EUCTR2005-003930-16-FI
(EUCTR)
05/01/200629/11/2005A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBINA Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who have been prescribed treatment with Avonex.
MedDRA version: 7.0;Level: PT;Classification code 10028425
Trade Name: Simvastatin Alternova
Product Name: Simvastatin Alternova
INN or Proposed INN: Simvastatin
Biogen Idec A/SNULLNot RecruitingFemale: yes
Male: yes
380Finland;Sweden
19EUCTR2005-004289-18-SE
(EUCTR)
04/01/200610/11/2005A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline)A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) Relapse Remitting Multiple Sclerosis
MedDRA version: 8.0;Level: PT;Classification code 10063399
Product Name: Minocycline 100 mg Film-coated Tablets
INN or Proposed INN: Minocycline Hydrochloride
Merck ABNULLNot RecruitingFemale: yes
Male: yes
320Finland;Sweden
20EUCTR2005-004289-18-DK
(EUCTR)
19/12/200528/11/2005A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline)A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) Relapse Remitting Multiple Sclerosis
MedDRA version: 8.0;Level: PT;Classification code 10063399
Product Name: Minocycline 100 mg Film-coated Tablets
INN or Proposed INN: Minocycline Hydrochloride
E. Merck ABNULLNot RecruitingFemale: yes
Male: yes
320Finland;Denmark;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2005-003930-16-DK
(EUCTR)
09/12/200505/12/2005A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBINA Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a.
MedDRA version: 7.0;Level: PT;Classification code 10028425
Product Name: Simvastatin Alternova
INN or Proposed INN: Simvastatin
Biogen Idec A/SNULLNot RecruitingFemale: yes
Male: yes
380Finland;Denmark;Sweden
22NCT00942591
(ClinicalTrials.gov)
May 200517/7/2009Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1bEfficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b.SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis.Multiple SclerosisDrug: Interferon beta 1b;Drug: AtorvastatinUniversity Hospital Inselspital, BerneCRO: PharmaPart AG, Bahnhofstrasse 20, P.O. Box 173, CH-8800 Thalwil;Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 BaselCompleted18 Years55 YearsBoth77Phase 2Switzerland
23EUCTR2004-003799-13-LT
(EUCTR)
08/03/200527/12/2004A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3bUnited Kingdom;Spain;Ireland;Sweden;Lithuania
24EUCTR2004-003799-13-DK
(EUCTR)
24/02/200518/01/2005A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden
25EUCTR2004-003799-13-ES
(EUCTR)
17/02/200504/11/2005A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Trade Name: Rebif
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3bUnited Kingdom;Ireland;Spain;Lithuania;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2004-003799-13-SE
(EUCTR)
03/02/200523/12/2004A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMSA multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria
MedDRA version: 7.0;Level: PT;Classification code 10028245
Product Name: Interferon-beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta-1a
Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process)
Serono International SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3bUnited Kingdom;Spain;Ireland;Lithuania;Sweden
27NCT00110396
(ClinicalTrials.gov)
January 20056/5/2005Rebif New Formulation (RNF) in Relapsing Forms of Multiple SclerosisA Multicentre, Single Arm, Open-Label, Phase IIIB Study to Evaluate the Safety and Antigenicity of Rebif® (Interferon-beta-1a) in Subjects With Relapsing Forms of Multiple SclerosisMultiple SclerosisBiological: Interferon-beta-1a FBS-free/HSA-freeEMD SeronoPfizerCompleted18 Years60 YearsAll260Phase 3United States
28NCT00493077
(ClinicalTrials.gov)
May 200425/6/2007Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta TherapyA Swedish Multi-Centre, Prospective, Open Label Study: Safety of Avonex Treatment in Multiple Sclerosis Patients Who Are NAB Positive on Previous s.c Interferon Beta TherapyMultiple SclerosisDrug: low immunogenic interferon-beta-1aBiogen IdecNULLCompleted18 Years55 YearsBoth3Phase 4Sweden
29NCT00493116
(ClinicalTrials.gov)
October 200325/6/2007Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon BetaA Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced BioavailabilityRelapsing-Remitting Multiple SclerosisDrug: Interferon-beta-1a;Drug: methylprednisoloneBiogen IdecNULLCompleted18 Years55 YearsBoth20Phase 4Australia;New Zealand
30NCT00492466
(ClinicalTrials.gov)
March 200325/6/2007Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing AntibodiesA Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta AntibodiesRelapsing-Remitting Multiple SclerosisDrug: Interferon-beta-1a;Drug: methylprednisoloneBiogen IdecNULLCompleted18 Years55 YearsBoth14Phase 4Finland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT00168766
(ClinicalTrials.gov)
January 200313/9/2005Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MSA Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: Interferon-beta-1a (Avonex) plus methylprednisoloneBiogen IdecNULLCompleted18 Years55 YearsBoth345Phase 4Belgium;Denmark;Finland;Netherlands;Norway;Sweden;Switzerland;United Kingdom
32NCT00151801
(ClinicalTrials.gov)
May 20028/9/2005Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS PatientsSafety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple SclerosisMultiple SclerosisDrug: estroprogestins;Drug: interferon-beta 1aS. Andrea HospitalNULLRecruiting18 Years40 YearsFemale200Phase 2Italy