Rebif® New Formulation ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica33

13. Multiple sclerosis/Neuromyelitis optica


Clinical trials : 3,342 Drugs : 2,355 - (DrugBank : 406) / Drug target genes : 269 - Drug target pathways : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-004954-34-AT
(EUCTR)
21/01/201009/12/2008Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
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
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Bulgaria;Germany
2NCT01101776
(ClinicalTrials.gov)
January 20108/4/2010Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting.Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical SettingMultiple SclerosisDrug: Interferon beta-1a (Rebif)Merck KGaAMerck Serono Australia Pty LtdCompleted18 YearsN/ABoth49N/AAustralia
3EUCTR2008-004954-34-PL
(EUCTR)
09/09/200905/06/2009Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
MedDRA version: 14.0;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
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany
4EUCTR2008-004954-34-BG
(EUCTR)
28/05/200929/05/2009Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
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
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Bulgaria;Germany
5EUCTR2008-004954-34-GR
(EUCTR)
19/05/200906/03/2009Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXIONDouble-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Rebif
INN or Proposed INN: Interferon-beta 1a
Merck Serono International, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, DarmstadtNULLNot RecruitingFemale: yes
Male: yes
492Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia
6EUCTR2008-004954-34-DE
(EUCTR)
05/05/200915/01/2009Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
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
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany
7EUCTR2008-004954-34-FR
(EUCTR)
08/04/200917/03/2009Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXIONDouble-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Rebif
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A.- Geneva, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia
8EUCTR2008-004954-34-LV
(EUCTR)
12/03/200927/02/2009Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXIONDouble-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Rebif
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Latvia;Germany
9EUCTR2008-004954-34-BE
(EUCTR)
09/03/200923/01/2009Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
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
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Germany
10EUCTR2008-004954-34-SK
(EUCTR)
05/03/200909/09/2009Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
MedDRA version: 13.1;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
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany
11EUCTR2008-004954-34-ES
(EUCTR)
03/03/200919/12/2008Extensión doble ciega del estudio 27025 (REFLEX) para obtener datos de seguimiento a largo plazo en pacientes con Esclerosis Múltiple clínicamente definida y en pacientes con un primer acontecimiento desmielinizante con alto riesgo de presentar conversión en Esclerosis Múltiple, tratados con Rebif® New Formulation (REFLEXION) - REFLEXIONExtensión doble ciega del estudio 27025 (REFLEX) para obtener datos de seguimiento a largo plazo en pacientes con Esclerosis Múltiple clínicamente definida y en pacientes con un primer acontecimiento desmielinizante con alto riesgo de presentar conversión en Esclerosis Múltiple, tratados con Rebif® New Formulation (REFLEXION) - REFLEXION Pacientes con riesgo alto de conversión en Esclerosis Múltiple o pacientes que ya han convertido a Esclerosis Múltiple.
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: REBIF 44 microgramos solución inyectable
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A
Merck Serono International, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, DarmstadtNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia
12EUCTR2008-004954-34-EE
(EUCTR)
13/02/200908/01/2009Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
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
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Bulgaria;Germany
13EUCTR2008-004954-34-PT
(EUCTR)
06/02/200905/01/2009Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXIONDouble-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Rebif
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia
14EUCTR2008-004954-34-FI
(EUCTR)
26/01/200917/12/2008Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
MedDRA version: 13.1;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
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany
15NCT00725985
(ClinicalTrials.gov)
December 31, 200830/7/2008Oral Cladribine in Early Multiple Sclerosis (MS)A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Oral Cladribine in Subjects With a First Clinical Event at High Risk of Converting to MSMultiple SclerosisDrug: Cladribine;Drug: Placebo;Drug: Rebif® new formulation (RNF)EMD SeronoNULLCompleted18 Years55 YearsAll617Phase 3United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Georgia;Germany;India;Italy;Korea, Republic of;Lebanon;Macedonia, The Former Yugoslav Republic of;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Arab Emirates;United Kingdom;Saudi Arabia
16EUCTR2008-004954-34-CZ
(EUCTR)
12/12/200821/11/2008Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis.
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
INN or Proposed INN: Interferon-beta 1a
Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany
17NCT00813709
(ClinicalTrials.gov)
December 200822/12/2008Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)Double-blind Extension of the Study 27025 (REFLEX) to Obtain Long-term Follow-up Data in Patients With Clinically Definite MS and Patients With a First Demyelinating Event at High Risk of Converting to MS, Treated With Rebif® New Formulation (REFLEXION)Multiple Sclerosis;Clinically Isolated SyndromeDrug: RNF;Drug: PlaceboMerck KGaANULLCompleted18 YearsN/AAll402Phase 3Argentina;Austria;Belgium;Bulgaria;Canada;Croatia;Czech Republic;Estonia;Finland;France;Germany;Greece;Israel;Italy;Latvia;Lebanon;Morocco;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Saudi Arabia;Turkey
18NCT01080027
(ClinicalTrials.gov)
October 20082/3/2010Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR)An International, Multi Centre, Prospective, Observational Study of Safety, Tolerability and Adherence of Patients With Relapsing Remitting Multiple Sclerosis Administered Interferon Beta-1a (Rebif® New Formulation) in Real Life SettingsMultiple Sclerosis, Relapsing RemittingDrug: Rebif® New FormulationMerck KGaAMerck A.E., Greece;Merck OY, Finland;Merck B.V., Netherlands;Merck A.B., Sweden;Merck, S.A., PortugalCompleted18 Years60 YearsBoth254N/AGreece
19NCT00735007
(ClinicalTrials.gov)
July 200812/8/200812-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis.International, Multicenter, Single-arm, Open-label, 12-week Phase IIIb Study to Evaluate RebiSmart™ Suitability for Self Injection of Rebif® New Formulation (RNF) in Multidose Cartridges in Patients With Relapsing Form of Multiple Sclerosis (RMS)Multiple SclerosisDrug: Rebif® New Formulation (RNF) using RebiSmartTMEMD SeronoNULLCompleted18 Years65 YearsAll106Phase 3United States;Canada;Germany;Italy;Spain;Sweden
20EUCTR2006-003037-32-LT
(EUCTR)
11/09/200727/11/2006A 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 sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A 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 sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
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: Not applicable
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;Estonia;Spain;Italy;Lithuania
21NCT00619307
(ClinicalTrials.gov)
July 20078/2/2008Transition to Rebif New FormulationA Randomized, Multicenter, Two-arm, Open-label, Phase IIIb Study to Evaluate the Satisfaction in Relapsing Multiple Sclerosis Subjects Transitioning to Rebif® New Formulation From Rebif® (Interferon Beta-1a) With Ibuprofen When Necessary (PRN) or as ProphylaxisRelapsing Multiple SclerosisDrug: Rebif New Formulation + prophylactic Ibuprofen;Drug: Rebif New Formulation + ibuprofen PRNMerck KGaANULLCompleted18 Years60 YearsAll117Phase 3France;Germany
22EUCTR2006-005972-42-DE
(EUCTR)
20/06/200715/08/2007A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNFA randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF Relapsing multiple sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: NA
Product Name: Interferon-beta 1a FBS-free/HSA-free, RNF
Product Code: NA
INN or Proposed INN: Interferon beta-1a
Other descriptive name: recombinant human IFN beta
Trade Name: Ibuprofen Sandoz 400 mg Filmtabletten
Product Name: Ibuprofen
INN or Proposed INN: Ibuprofen
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
120Phase 3Germany;France
23EUCTR2006-005972-42-FR
(EUCTR)
12/06/200705/04/2007A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNFA randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF Relapsing multiple sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: NA
Product Name: Interferon-beta 1a FBS-free/HSA-free, RNF
Product Code: NA
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;Germany
24EUCTR2006-003037-32-DE
(EUCTR)
13/04/200701/12/2006A 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 sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A 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 sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
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: Not applicable
Merck Serono SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;Estonia;Spain;Italy;Lithuania
25EUCTR2006-003037-32-EE
(EUCTR)
06/03/200726/01/2007A 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 sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A 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 sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
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: Not applicable
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;Estonia;Spain;Italy;Lithuania
26EUCTR2006-003037-32-ES
(EUCTR)
09/02/200710/03/2010Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A 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 sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A 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 sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
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: Not applicable
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Estonia;Spain;Lithuania;Germany;Italy
27NCT00441103
(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
28EUCTR2004-003799-13-GB
(EUCTR)
16/03/200518/07/2005A 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 Recruiting Female: yes
Male: yes
230 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden
29EUCTR2004-003799-13-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 3United Kingdom;Spain;Ireland;Sweden;Lithuania
30EUCTR2004-003799-13-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
31EUCTR2004-003799-13-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 SANULLNot RecruitingFemale: yes
Male: yes
230Phase 3Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden
32EUCTR2004-003799-13-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 3United Kingdom;Spain;Ireland;Lithuania;Sweden
33EUCTR2004-003799-13-IE
(EUCTR)
13/01/2005A 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 Recruiting Female: yes
Male: yes
230 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden