Glatiramer    (DrugBank: Glatiramer)

4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症4
13多発性硬化症/視神経脊髄炎184
96クローン病1
156レット症候群2

2. 筋萎縮性側索硬化症 [臨床試験数:508,薬物数:530(DrugBank:146),標的遺伝子数:170,標的パスウェイ数:221
Searched query = "Amyotrophic lateral sclerosis", "ALS"
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.
4 / 508 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-001688-49-GB14/08/200628/04/2006A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a.A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a. Early stage of amyotrophic lateral sclerosis (ALS)
MedDRA version: 8.1 Level: PT Classification code 10002026
TEVA Pharmaceutical Industries. Ltd.NULLNot Recruiting Female: yes
Male: yes
366 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noBelgium;Germany;Italy;United Kingdom
2NCT00326625July 31, 200616/5/2006Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of 40 mg Glatiramer Acetate Injection in Subjects With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: 40 mg glatiramer acetate;Drug: PlaceboTeva Pharmaceutical Industries, Ltd.NULLCompleted18 Years70 YearsAll366Phase 2Belgium;France;Germany;Israel;Italy;United Kingdom
3EUCTR2006-001688-49-DE31/07/200624/05/2006A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a.A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a. Early stage of amyotrophic lateral sclerosis (ALS)
MedDRA version: 8.1Level: PTClassification code 10002026
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
TEVA Pharmaceutical Industries. Ltd.NULLNot RecruitingFemale: yes
Male: yes
300United Kingdom;Germany;Belgium;Italy
4EUCTR2006-001688-49-BE26/06/200610/05/2006A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a.A multi-national, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, tolerability and safety of 40 mg glatiramer acetate injection in subjects with amyotrophic lateral sclerosis (ALS) - n.a. Early stage of amyotrophic lateral sclerosis (ALS)
MedDRA version: 8.1Level: PTClassification code 10002026
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
TEVA Pharmaceutical Industries. Ltd.NULLNot RecruitingFemale: yes
Male: yes
300Germany;United Kingdom;Belgium;Italy

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", "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.
184 / 3,050 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04079088June 30, 20213/9/2019Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-ß1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS)A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: Placebo;Drug: BIIB061;Biological: Interferon-beta1;Drug: Glatiramer acetateBiogenNULLNot yet recruiting18 Years55 YearsAll300Phase 2NULL
2EUCTR2018-000284-93-EE10/12/201902/10/2019A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeksA multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks Relapsing forms of Multiple Sclerosis (RMS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GA Depot
INN or Proposed INN: GLATIRAMER ACETATE
Mapi Pharma Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
960Phase 3United States;Serbia;Belarus;Estonia;Ukraine;Russian Federation;Israel;Montenegro;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Croatia;Romania;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
3EUCTR2018-000284-93-BG15/11/201908/10/2019A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeksA multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks Relapsing forms of Multiple Sclerosis (RMS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GA Depot
INN or Proposed INN: GLATIRAMER ACETATE
Mapi Pharma Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
960Phase 3United States;Serbia;Belarus;Estonia;Ukraine;Russian Federation;Israel;Montenegro;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Croatia;Romania;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
4NCT04121221September 19, 20198/10/2019A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMSA Phase III Study in Subjects With Relapsing Forms of Multiple Sclerosis (RMS) to Asses Efficacy, Safety and Tolerability of GA Depot, a Long Acting IM Injection of Glatiramer Acetate, Once Monthly Compared to PlaceboMultiple Sclerosis, Relapsing-RemittingDrug: GA Depot;Other: PlaceboMapi Pharma Ltd.NULLRecruiting18 Years55 YearsAll960Phase 3United States;Bulgaria;Estonia;Georgia;Moldova, Republic of;Russian Federation;Ukraine
5NCT03362294December 11, 201715/11/2017Safety and Efficacy of Monthly Long-acting IM Injection of 40 mg GA Depot in Subjects With PPMSA Prospective, Multicenter, Single Arm, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 40mg Glatiramer Acetate (GA Depot) in Subjects With Primary Progressive Multiple Sclerosis (PPMS)Primary Progressive Multiple SclerosisDrug: GA Depot 40mg once monthlyMapi Pharma Ltd.NULLRecruiting18 Years65 YearsAll24Phase 2Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03315923December 1, 201717/10/2017Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis PatientsComparison of Expanded Disability Status Scale, Gad-enhanced Brain Lesions, Annualized Relapse Rate, and Side Effects Between Active Secondary Progressive Multiple Sclerosis Patients on Rituximab and Glatiramer AcetateSecondary Progressive Multiple SclerosisDrug: Rituximab;Drug: Glatiramer AcetateIsfahan University of Medical SciencesNULLCompleted18 Years55 YearsAll84Phase 2/Phase 3Iran, Islamic Republic of
7NCT03368664October 24, 20172/11/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMTA Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)Multiple SclerosisDrug: Alemtuzumab GZ402673;Drug: Glatiramer acetate;Drug: Beta-Interferon;Drug: Methylprednisolone;Drug: Ranitidine;Drug: Ceterizine;Drug: Dexchlorpheniramine;Drug: Paracetamol;Drug: Acyclovir;Drug: Prednisolone;Drug: Diphenydramine;Drug: Other H1 antagonistGenzyme, a Sanofi CompanyNULLActive, not recruiting10 Years17 YearsAll50Phase 3Austria;Belgium;Bulgaria;Czechia;France;Germany;Greece;Italy;Netherlands;Poland;Portugal;Russian Federation;Spain;Turkey;United Kingdom;Norway;Switzerland
8EUCTR2017-002634-24-SE29/09/201706/07/2017MultipleMS – 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
9EUCTR2016-003587-39-SE22/05/201723/03/2017This 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
10EUCTR2015-000922-12-DE12/02/201602/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2015-000922-12-FR28/01/201626/02/2016A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
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]
Teva Pharmaceutical Industries, LtdNULLNot Recruiting Female: yes
Male: yes
840 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesUnited States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
12EUCTR2015-000922-12-ES12/01/201613/01/2016A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
820Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
13EUCTR2015-000922-12-PL05/01/201603/12/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
14EUCTR2015-000922-12-BE04/01/201601/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
15EUCTR2015-000922-12-IE22/12/201509/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
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]
Teva Pharmaceutical Industries, LtdNULLNot Recruiting Female: yes
Male: yes
840 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesUnited States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2015-004116-38-SE18/12/201520/10/2015A clincial study comparing the effectiveness of two drugs, named Rituximab and Dimethyl Fumarate (Tecfidera®), for the neurological disease Multiple Sclerosis.RItuximab versus FUmarate in Newly Diagnosed Multiple Sclerosis – RIFUND-MSA randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple SclerosisObjective: To compare the efficacy of rituximab on the ability to prevent relapses in early RRMS and CIS compared with dimethyl fumarate (DMF), which is an approved first-line medication for RRMS today, using a phase 3 design.Population: Patients with newly diagnosed RRMS or CIS with no more than 10 years disease duration (since diagnosis), 18 – 50 years of age and previously not treated with immunomodulating drugs OR treated with first-line injectables. Patients should display protocol-defined clinical or radiological disease activity during the preceding year before screening for inclusion.Intervention: Treatment with rituximab (Mabthera®) with an initial dose of 1000 mg intravenously (iv) followed by 500 mg iv every six months.Control: Treatment with DMF (Tecfidera®) 240 mg twice daily. The two treatments are randomised in a 1:1 proportion.Outcome: Primary outcome is the relative risk of experiencing a relapse during the two–year period for either compound. As secondary endpoints worsening on neurological disability, magnetic-resonance imaging-defined disease activity and effect on cerebrospinal fluid biomarkers will be analysed. In addition, health-economic evaluations of using rituximab as first-line treatment for RRMS will be performed. Patients with multiple sclerosis (MS) or patients presenting with symptoms highly suspicious of MS while not completely fulfilling diagnostic criteria, 18 - 50 years of age and no more than 10 years of disease duration (from diagnosis). Patients treated with immunomodulatory drugs or treated with first-line injectable therapies (eg interferons or glatiramer acetate) may be included.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Department of Clinical Sciences, Danderyd HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Sweden
17EUCTR2015-000922-12-FI15/12/201507/12/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
18EUCTR2015-000922-12-HR11/12/201504/02/2016A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
19JPRN-JapicCTI-15305824/11/201504/11/2015Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) Prevention of Relapse of Multiple SclerosisCopaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) Prevention of Relapse of Multiple Sclerosis Multiple sclerosisIntervention name : Copaxone subcutaneous injection syringe
Dosage And administration of the intervention : For adults, a 20 mg dose of glatiramer acetate will be subcutaneously administered once daily.Participants will receive interventions as part of routine medical care.
TAKEDA PHARMACEUTICAL COMPANY LTD.NULLrecruitingBOTH1000NANULL
20NCT03209479November 24, 20154/7/2017Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) Prevention of Relapse of Multiple SclerosisCopaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) Prevention of Relapse of Multiple SclerosisMultiple SclerosisDrug: Glatiramer acetateTakedaNULLRecruitingN/AN/AAll1000Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2015-000922-12-AT19/11/201501/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
22EUCTR2012-003735-32-GR19/11/201506/08/2015Study to compare the efficacy and/or safety of masitinib to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments.A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment Relapsing-remitting multiple sclerosis (RR MS)
MedDRA version: 18.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: mastinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: masitinib mesylate
Product Name: mastinib
Product Code: AB1010
INN or Proposed INN: masitinb mesylate
Other descriptive name: masitinib mesylate
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Bulgaria;Germany
23EUCTR2015-000922-12-IT05/11/201528/02/2018A clinical study to assess medication satisfaction in patients with RelapsingRemitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/mlThree Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Studyto Assess Medication Satisfaction in Patients with Relapsing RemittingMultiple Sclerosis (RRMS) Treated with Subcutaneous Injections ofCopaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Comparedto 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE 30 SIRINGHE
INN or Proposed INN: GLATIRAMER ACETATO
Other descriptive name: GLATIRAMER ACETATO
Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO
INN or Proposed INN: GLATIRAMER ACETATO
Other descriptive name: GLATIRAMER ACETATO
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INCNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
24NCT02499900August 10, 20151/7/2015Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL DailyMultiple SclerosisDrug: Copaxone®Teva Pharmaceutical Industries, Ltd.NULLCompleted18 YearsN/AAll861Phase 4United States;Argentina;Austria;Belgium;Croatia;Finland;France;Germany;Ireland;Italy;Mexico;Poland;Puerto Rico;Russian Federation;Spain;Turkey
25NCT02323269May 201518/12/2014Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing-Remitting Multiple Sclerosis, Who Are Either Treatment-Naïve or Switching From an Interferon or Glatiramer Acetate After Suboptimal Response (ImPROve)Multiple Sclerosis, Relapsing-Remitting;Relapsing-Remitting Multiple SclerosisDrug: dimethyl fumarateBiogenNULLTerminated18 YearsN/ABoth24N/ACanada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2012-003735-32-SK01/04/201509/04/2015Study to compare the efficacy and/or safety of masitinib at 3 mg/kg/day with switch to 4.5 then to 6 mg/kg/day to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments. A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment Prospective, multicentre, randomised, open-label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 mg/kg/day with switch to 4.5 then 6 mg/kg/day as single agent first line treatment.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]AB ScienceNULLNot Recruiting Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSlovakia;Greece;Spain;Colombia;Switzerland;United Kingdom;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;Germany
27EUCTR2012-005086-12-PL07/01/201516/09/2014Study 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: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem 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
28EUCTR2014-001012-19-NL17/12/201415/10/2014Effects of fingolimod on advanced brain measures and clinical measures in multiple sclerosisEffects of fingolimod on functional brain adaptation and clinical measures in multiple sclerosis - Effect of fingolimod on brain and cognition Relapsing-remitting (RR) multiple sclerosis (MS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Gilenya
INN or Proposed INN: fingolimod
Product Name: Interferon Beta
INN or Proposed INN: interferon beta-1b
Other descriptive name: INTERFERON BETA-1B
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
VU University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
29EUCTR2013-002378-26-SE13/11/201415/08/2013Switch To RItuXimab in MS extensionAn extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytesSwitch To RItuXimab in MS extensionAn extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSext The original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate. This extension study involves the same patients, those that consent to participate in this extension trial.
MedDRA version: 16.0Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mabthera®
Product Name: Mabthera
Västerbottens Läns LandstingNULLNot RecruitingFemale: yes
Male: yes
74Phase 2Sweden
30NCT02212886October 20145/8/2014Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMSA Prospective 1-year, Open-label, Two Arms, Multicenter, Phase IIa Study to Assess Safety, Tolerability and Efficacy of Once a Month Long-acting Intramuscular Injection of 80 or 40 mg Glatiramer Acetate (GA Depot) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)Multiple SclerosisDrug: GA Depot 80 mg;Drug: GA Depot 40 mgMapi Pharma Ltd.NULLActive, not recruiting18 Years70 YearsAll25Phase 1/Phase 2Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2013-002283-25-PL18/04/201421/01/2014A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple SclerosisA Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 17.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Trade Name: Copaxone
INN or Proposed INN: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
550Phase 2Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria
32EUCTR2013-002283-25-GR18/03/201401/11/2013A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple SclerosisA Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 16.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Trade Name: Copaxone
INN or Proposed INN: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
550Phase 2United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa
33EUCTR2013-002283-25-GB18/03/201409/10/2013A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple SclerosisA Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 17.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Trade Name: Copaxone
INN or Proposed INN: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
550Phase 2Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria
34EUCTR2013-002283-25-BG07/02/201404/12/2013A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple SclerosisA Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 17.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Trade Name: Copaxone
INN or Proposed INN: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
550Phase 2United States;Serbia;Greece;Finland;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa
35EUCTR2013-002283-25-ES31/01/201406/11/2013A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple SclerosisA Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 16.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Plovamer acetate
Product Code: MSC2491529A
INN or Proposed INN: --
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
INN or Proposed INN: --
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
INN or Proposed INN: --
Other descriptive name: Plovamer acetate
Trade Name: Copaxone
INN or Proposed INN: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
550Phase 2United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2013-004626-28-FI20/12/201320/11/2013Does 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: 14.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem 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
37EUCTR2013-002283-25-CZ18/12/201326/09/2013A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple SclerosisA Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 17.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Trade Name: Copaxone
INN or Proposed INN: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
550Phase 2Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria
38EUCTR2013-002283-25-FI09/12/201325/10/2013A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple SclerosisA Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 17.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Trade Name: Copaxone
INN or Proposed INN: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
550Phase 2Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria
39EUCTR2013-002283-25-HU25/11/201308/10/2013A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple SclerosisA Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 17.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
Other descriptive name: Plovamer acetate
Trade Name: Copaxone
INN or Proposed INN: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
550Phase 2Serbia;United States;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Poland;Croatia;South Africa;Bulgaria
40EUCTR2012-005086-12-BG14/11/201319/08/2013Study 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: 18.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2012-005086-12-DE12/11/201301/07/2013Study 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: 17.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem 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
42EUCTR2013-002283-25-IT29/10/201308/10/2013A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple SclerosisA Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis - Efficacy, safety, and tolerability of plovamer acetate Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 16.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Plovamer acetate
Product Code: MSC2491529A
INN or Proposed INN: ND
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
INN or Proposed INN: ND
Other descriptive name: Plovamer acetate
Product Name: Plovamer acetate
Product Code: MSC2491529A
INN or Proposed INN: ND
Other descriptive name: Plovamer acetate
Trade Name: Copaxone
INN or Proposed INN: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
550Phase 2United States;Serbia;Greece;Finland;Spain;Turkey;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa
43NCT01903291August 201317/7/2013Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMSA Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer AcetateRelapsing Forms of Multiple SclerosisDrug: dimethyl fumarateBiogenNULLCompleted18 YearsN/ABoth333N/AUnited States
44EUCTR2012-005086-12-HU31/07/201318/06/2013Study 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: 17.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem 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
45EUCTR2012-005086-12-AT05/07/201308/05/2013Study 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: 18.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT01874145June 20136/6/2013Safety and Tolerability of Glatiramer AcetateAn Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of Glatiramer Acetate 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily Subcutaneous Injections in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: GA 20 mg/mL;Drug: GA 40 mg/mLTeva Pharmaceutical IndustriesNULLCompleted18 YearsN/AAll209Phase 3United States
47EUCTR2011-001437-16-DE19/09/201209/02/2012A 3 year study to determine if optical coherence tomography can be used to measure disease progression in patients with multiple sclerosisA 3-year, multi-center study to evaluate optical coherence tomography as an outcome measure in patients with multiple sclerosis - multiple sclerosis
MedDRA version: 15.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
INN or Proposed INN: Fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Extavia
INN or Proposed INN: Interferon beta-1b
Other descriptive name: INTERFERON BETA-1B
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Germany;Switzerland;Netherlands;France;Italy;Austria;Australia;Czech Republic;United Kingdom;Canada;Denmark;Spain;United States;Poland
48NCT01633112August 9, 201229/6/2012MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus CopaxoneA 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple Sclerosis (RRMS)Drug: fingolimod;Drug: glatiramer acetateNovartis PharmaceuticalsNULLTerminated18 Years65 YearsAll1064Phase 3United States;Argentina;Brazil;Canada;Chile;Mexico;Puerto Rico
49EUCTR2011-005550-57-GR05/06/201209/05/2012A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug).A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study Relapsing-remitting Multiple sclerosis (RRMS)
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 20mg/0.5ml glatiramer acetate
Product Code: 20mg/0.5ml GA
INN or Proposed INN: glatiramer acetate
Other descriptive name: glatiramer acetate
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
1400Montenegro;Bulgaria;Latvia;Lithuania;Albania;Russian Federation;Serbia;Ukraine;Belarus;Mexico;Georgia;Romania;Estonia;Bosnia and Herzegovina;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Moldova, Republic of
50EUCTR2011-005550-57-EE21/05/201214/02/2012A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug).A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study Relapsing-remitting Multiple sclerosis (RRMS)
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 20mg/0.5ml glatiramer acetate
Product Code: 20mg/0.5ml GA
INN or Proposed INN: glatiramer acetate
Other descriptive name: glatiramer acetate
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
1400Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Albania;Bulgaria;Latvia;Germany;Moldova, Republic of;Bosnia and Herzegovina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2011-005550-57-LV15/05/201209/02/2012A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug).A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study Relapsing-remitting Multiple sclerosis (RRMS)
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 20mg/0.5ml glatiramer acetate
Product Code: 20mg/0.5ml GA
INN or Proposed INN: glatiramer acetate
Other descriptive name: glatiramer acetate
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
1400Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Albania;Bulgaria;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
52EUCTR2011-005550-57-BG14/05/201207/03/2012A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug).A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study Relapsing-remitting Multiple sclerosis (RRMS)
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 20mg/0.5ml glatiramer acetate
Product Code: 20mg/0.5ml GA
INN or Proposed INN: glatiramer acetate
Other descriptive name: glatiramer acetate
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
1400Germany;Moldova, Republic of;Bosnia and Herzegovina;Latvia;Serbia;United States;Belarus;Estonia;Greece;Ukraine;Lithuania;Russian Federation;Montenegro;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Poland;Romania;Croatia;Georgia;Bulgaria;Albania
53EUCTR2011-005550-57-PL04/04/201209/03/2012A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug).A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study Relapsing-remitting Multiple sclerosis (RRMS)
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: 20mg/0.5ml glatiramer acetate
Product Code: 20mg/0.5ml GA
INN or Proposed INN: glatiramer acetate
Other descriptive name: glatiramer acetate
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
1400Hungary;Germany;Montenegro;Bulgaria;Latvia;Lithuania;Albania;Russian Federation;Czech Republic;Ukraine;Serbia;Belarus;Mexico;Georgia;Romania;Estonia;Bosnia and Herzegovina;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Moldova, Republic of
54NCT01578785March 201213/3/2012An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)A Multinational, Multicenter, Randomized, Parallel Group, Double Blind, Placebo Controlled Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate 20mg/0.5ml New Formulation Administered Daily by Subcutaneous InjectionRelapsing-Remitting Multiple SclerosisDrug: Glatiramer Acetate;Drug: PlaceboTeva Pharmaceutical IndustriesNULLTerminated18 Years55 YearsAll178Phase 3United States;Albania;Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Estonia;Georgia;Greece;Latvia;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;Montenegro;Poland;Romania;Russian Federation;Serbia;Ukraine;Lithuania
55NCT01404117March 201226/7/2011A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and TolerabilityRelapsing Multiple SclerosisDrug: Laquinimod 0.6;Drug: Laquinimod 1.2;Other: Glatiramer Acetate or interferon-beta+ PlaceboTeva Pharmaceutical IndustriesNULLWithdrawn18 Years55 YearsBoth0Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT01569451February 201230/3/2012Comparison of Rituximab Induction Therapy Followed by Glatiramer AcetateA Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: Rituximab;Drug: Glatiramer Acetate;Other: PlaceboUniversity of Colorado, DenverRocky Mountain MS Research Group, LLCCompleted18 Years55 YearsAll53Phase 2United States
57EUCTR2011-000888-27-DE24/01/201219/08/2011A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment.Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE Relapsing remitting multiple sclerosis
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: glatiramer acetate
Product Code: GTR
INN or Proposed INN: glatiramer acetate
Other descriptive name: GTR.ace
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Synthon BVNULLNot RecruitingFemale: yes
Male: yes
750United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany
58EUCTR2011-000888-27-GR09/01/201213/12/2011A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment.Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE Relapsing remitting multiple sclerosis
MedDRA version: 14.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: glatiramer acetate
Product Code: GTR
INN or Proposed INN: glatiramer acetate
Other descriptive name: GTR.ace
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Synthon BVNULLNot RecruitingFemale: yes
Male: yes
750Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany
59NCT01534182January 20128/2/2012Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (Fingolimod) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for Multiple Sclerosis (MS) Therapy Change From Previous Disease Modifying Therapy (DMT)Relapsing Remitting Multiple SclerosisDrug: Fingolimod;Drug: Interferon beta - 1a (IFN);Drug: Glatiramer acetate (GA)Novartis PharmaceuticalsNULLCompleted18 Years65 YearsAll298Phase 4Russian Federation
60NCT01498887December 24, 201119/12/2011Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying TherapyA Multi-centre, Open-label, Non-randomised, Parallel Group Clinical Trial to Assess the Efficacy of Fingolimod in Naive Patients Versus Fingolimod in Patients Previously Treated With Interferons or Glatiramer Acetate, Based on the Presence of Relapses in Patients With Relapsing-remitting Multiple Sclerosis.Relapsing Remitting Multiple SclerosisDrug: Fingolimod (FTY720)Novartis PharmaceuticalsNULLCompleted18 Years50 YearsAll347Phase 4Australia;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2011-000888-27-RO18/11/201109/10/2012A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment.Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE Relapsing remitting multiple sclerosis
MedDRA version: 15.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: glatiramer acetate
Product Code: GTR
INN or Proposed INN: glatiramer acetate
Other descriptive name: GTR.ace
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Synthon BVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750United States;Belarus;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany
62EUCTR2011-003484-30-ES26/10/201112/04/2012A multi-centre, open-label, non-randomised, parallel group clinical trial to assess the efficacy of fingolimod in naïve patients versus fingolimod in patients previously treated with interferons or glatiramer acetate, based on the presence of relapses in patients with relapsing-remitting multiple sclerosis.A multi-centre, open-label, non-randomised, parallel group clinical trial to assess the efficacy of fingolimod in naïve patients versus fingolimod in patients previously treated with interferons or glatiramer acetate, based on the presence of relapses in patients with relapsing-remitting multiple sclerosis. - Earlims Multiple Sclerosis relapsing-remitting course;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Gilenya
INN or Proposed INN: Fingolimod
Novartis Farmacéutica S.A.NULLNot RecruitingFemale: yes
Male: yes
432Phase 3Spain;Australia
63EUCTR2011-000888-27-GB24/10/201101/08/2011A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment.Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE Relapsing remitting multiple sclerosis
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: glatiramer acetate
Product Code: GTR
INN or Proposed INN: glatiramer acetate
Other descriptive name: GTR.ace
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Synthon BVNULLNot RecruitingFemale: yes
Male: yes
750Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany
64EUCTR2011-000888-27-IT13/10/201124/01/2012A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment.Multi-centre, randomized, double-blind, placebo-controlled, parallelgroup, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE Relapsing remitting multiple sclerosis
MedDRA version: 14.1Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: glatiramer acetate
Product Code: GTR
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GTR.ace
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: glatiramer acetate
SYNTHON BVNULLNot RecruitingFemale: yes
Male: yes
750United States;Estonia;Czech Republic;Greece;Ukraine;Romania;Croatia;Bulgaria;Russian Federation;Germany;United Kingdom;Italy
65NCT01489254October 20118/12/2011Efficacy and Safety of GTR in Comparison to Copaxone®Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, 9 Month, Equivalence Trial Comparing the Efficacy and Safety and Tolerability of GTR (Synthon BV) to Copaxone® (Teva) in Subjects With Relapsing Remitting Multiple Sclerosis Followed by an Open-label 15 Month GTR Treatment Part Evaluating the Long-term GTR Treatment EffectsMultiple SclerosisDrug: Glatiramer Acetate (GTR);Drug: Glatiramer Acetate (Copaxone®);Drug: PlaceboSynthon BVNULLCompleted18 Years55 YearsAll794Phase 3United States;Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Czech Republic;Estonia;Georgia;Germany;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;South Africa;Ukraine;United Kingdom;Greece;Kazakhstan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2011-000888-27-EE21/09/201101/09/2011A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment.Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE Relapsing remitting multiple sclerosis
MedDRA version: 15.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: glatiramer acetate
Product Code: GTR
INN or Proposed INN: glatiramer acetate
Other descriptive name: GTR.ace
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Synthon BVNULLNot RecruitingFemale: yes
Male: yes
750Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany
67EUCTR2011-000888-27-CZ21/09/201117/06/2011A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment.Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE Relapsing remitting multiple sclerosis
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: glatiramer acetate
Product Code: GTR
INN or Proposed INN: glatiramer acetate
Other descriptive name: GTR.ace
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Synthon BVNULLNot RecruitingFemale: yes
Male: yes
750Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany
68EUCTR2011-000888-27-BG18/08/201111/07/2011A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment.Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE Relapsing remitting multiple sclerosis
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: glatiramer acetate
Product Code: GTR
INN or Proposed INN: glatiramer acetate
Other descriptive name: GTR.ace
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Synthon BVNULLNot RecruitingFemale: yes
Male: yes
750Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Italy;United Kingdom;Czech Republic;Poland;Romania;Croatia;Bulgaria;Germany
69EUCTR2011-000150-31-IT13/04/201128/12/2011EFFECTS OF GLATIRAMER ACETATE ON TISSUE DAMAGE, CORTICAL FUNCTIONS AND FATIGUE IN MULTIPLE SCLEROSIS: A MORPHO-FUNCTIONAL MRI STUDY.EFFECTS OF GLATIRAMER ACETATE ON TISSUE DAMAGE, CORTICAL FUNCTIONS AND FATIGUE IN MULTIPLE SCLEROSIS: A MORPHO-FUNCTIONAL MRI STUDY. Multiple Sclerosis patients
MedDRA version: 14.1Level: HLGTClassification code 10012303Term: Demyelinating disordersSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1Level: HLTClassification code 10052785Term: Multiple sclerosis acute and progressiveSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: COPAXONE
INN or Proposed INN: Glatiramer acetate
FONDAZIONE DON CARLO GNOCCHI ONLUSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
70EUCTR2010-024017-31-IT15/03/201108/02/2011A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDENA 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDEN Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1Level: LLTClassification code 10063399
Product Name: FINGOLIMOD
Product Code: FTY720D
Trade Name: EXTAVIA
INN or Proposed INN: Interferon beta-1b
Trade Name: AVONEX
INN or Proposed INN: Interferon beta-1a
Trade Name: COPAXONE
INN or Proposed INN: Glatiramer acetate
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2010-023021-38-SE23/02/201126/11/2010Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSSwitch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS Relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate
MedDRA version: 12.1Level: LLTClassification code 10028245Term: Multiple sclerosis
Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Västerbottens läns landstingNULLNot RecruitingFemale: yes
Male: yes
Phase 2Sweden
72NCT01454791January 20119/8/2011Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer AcetateDiclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate: A Randomized Controlled Double- Blind Crossover TrialMultiple SclerosisDrug: diclofenac sodium topical gel;Other: PlaceboBrown, Theodore R., M.D., MPHTeva Neuroscience, Inc.Completed18 YearsN/AAll40Phase 4United States
73EUCTR2009-015556-15-AT19/11/201007/06/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
74NCT00939549November 201014/7/2009High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple SclerosisPhase II Study of High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: Cyclophosphamide/Glatiramer acetateJohns Hopkins UniversityNULLWithdrawn18 Years70 YearsAll0Phase 2United States
75EUCTR2009-015556-15-GB02/09/201017/03/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2009-015556-15-DK25/08/201017/06/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden
77EUCTR2009-015556-15-DE20/08/201019/03/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
78EUCTR2009-015556-15-NL13/08/201008/04/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms solution for injection in pre-filled syringe
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
79EUCTR2009-018084-27-GB29/07/201008/06/2010A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 16.1 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]
Teva Pharmaceutical Industries, Ltd.NULLNot Recruiting Female: yes
Male: yes
1350 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noRussian Federation;United Kingdom;Italy;Czech Republic;Hungary;Poland;Croatia;Romania;South Africa;Georgia;Bulgaria;Germany;United States;Estonia;Ukraine;Lithuania;Israel
80EUCTR2009-018084-27-BG19/07/201030/04/2010A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 19.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;South Africa;Georgia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2009-015556-15-HU14/07/201007/04/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Hungary;Portugal;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
82EUCTR2009-015556-15-GR13/07/201014/12/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
83EUCTR2009-012716-40-PL06/07/201011/01/2010The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trialThe Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial Relapsing-remitting multiple sclerosis
MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: PI-2301
Product Code: PI-2301
Product Name: PI-2301
Product Code: PI-2301
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Peptimmune Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 2Germany;Czech Republic;Bulgaria;France;Estonia;Poland
84EUCTR2009-016087-37-IT02/07/201021/07/2010A multinational, multicenter, single blood samplingexploratory pharmacogenetic study of the REGARD (theREbif vs Glatiramer Acetate in Relapsing MS Disease)trial - REGARD PGxA multinational, multicenter, single blood samplingexploratory pharmacogenetic study of the REGARD (theREbif vs Glatiramer Acetate in Relapsing MS Disease)trial - REGARD PGx Multiple Sclerosis
MedDRA version: 9.1Level: LLTClassification code 10028245
Trade Name: REBIF
INN or Proposed INN: Interferon beta-1a
MERCK SERONO SANULLNot RecruitingFemale: yes
Male: yes
325United Kingdom;France;Ireland;Spain;Italy
85EUCTR2009-015556-15-PT02/07/201030/03/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT01167426July 201020/7/2010Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) PatientsAn Open-Label, Multicenter Study Evaluating Patient Injection Satisfaction With Two Formulations of Glatiramer Acetate (GA) Using Autoject 2 as the Subcutaneous Injection Delivery Method.Multiple SclerosisDrug: Glatiramer Acetate 20 mg/0.5 mL;Drug: Glatiramer acetate 20 mg/0.5 mLTeva Neuroscience, Inc.NULLCompleted18 YearsN/AAll148Phase 3United States
87NCT01067521June 22, 201010/2/2010A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to PlaceboA Multinational, Multicenter, Randomized, Parallel-group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo in a Double-blind DesignRelapsing Remitting Multiple SclerosisDrug: Glatiramer acetate (GA);Drug: PlaceboTeva Pharmaceutical Industries, Ltd.NULLCompleted18 Years55 YearsAll1404Phase 3United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Hungary;Israel;Italy;Lithuania;Poland;Romania;Russian Federation;South Africa;Ukraine;United Kingdom;Czech Republic;Turkey
88EUCTR2009-018084-27-DE16/06/201009/03/2010A clincial study to find out whether Copaxone (glatiramer acetate 40mg/1ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 17.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany
89EUCTR2009-015556-15-LV11/06/201013/04/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 13.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
76United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;Germany;Netherlands;Sweden
90EUCTR2009-015556-15-CZ10/06/201029/03/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 13.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
76United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Germany;Netherlands;Latvia;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2009-015556-15-SI07/06/201012/04/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
76Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Canada;Denmark;Slovenia;Spain;Greece;United States
92EUCTR2009-015556-15-IT07/06/201007/06/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - NDA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1Level: LLTClassification code 10063399
Trade Name: TYSABRI
INN or Proposed INN: Natalizumab
Trade Name: COPAXONE
INN or Proposed INN: Glatiramer acetate
Trade Name: REBIF
INN or Proposed INN: Interferon beta-1a
Trade Name: REBIF*SC 12SIR 6000000UI 22MCG
INN or Proposed INN: Interferon beta-1a
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
93EUCTR2009-018084-27-CZ01/06/201029/03/2010A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany
94NCT01156311June 20101/7/2010BG00012 Phase 2 Combination Study in Participants With Multiple SclerosisAn Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 TID Administered as Add-On Therapy to Beta Interferons (IFNß) or Glatiramer Acetate (GA)Relapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: dimethyl fumarateBiogenNULLCompleted18 Years55 YearsAll108Phase 2United States
95EUCTR2009-018084-27-LT28/05/201001/04/2010A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3United States;Estonia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2009-012716-40-DE28/05/201016/12/2009The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trialThe Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial Relapsing-remitting multiple sclerosis
MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: PI-2301
Product Code: PI-2301
Product Name: PI-2301
Product Code: PI-2301
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Peptimmune Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 2France;Czech Republic;Estonia;Slovakia;Poland;Bulgaria;Germany
97EUCTR2009-015556-15-ES24/05/201024/03/2010Estudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSEstudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Esclerosis Múltiple Recidivante-RemitenteRelapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Trade Name: TYSABRI 300 mg concentrado para solución para perfusión
INN or Proposed INN: NATALIZUMAB
Other descriptive name: NATALIZUMAB
Trade Name: COPAXONE 20 mg/ml solución inyectable en jeringa precargada
INN or Proposed INN: GLATIRAMERO ACETATO
Other descriptive name: GLATIRAMER ACETATE
Trade Name: REBIF 44 microgramos solución inyectable en jeringa precargada
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
98EUCTR2009-018084-27-IT19/05/201007/06/2010A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design - GALAA multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design - GALA Subject with Relapse-Remitting Multiple Sclerosis
MedDRA version: 9.1Level: LLTClassification code 10063399
Product Name: 40 mg Glatiramer Acetate
Product Code: 40 mg GA
INN or Proposed INN: Glatiramer acetate
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3Czech Republic;Estonia;Hungary;Lithuania;Bulgaria;Germany;United Kingdom;Italy
99EUCTR2009-018084-27-EE07/05/201016/03/2010A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Poland;Croatia;Romania;Georgia;South Africa;Bulgaria;Germany
100EUCTR2009-015556-15-FI07/05/201024/02/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2009-015556-15-SE06/05/201009/03/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 13.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack.
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
76United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Canada;Denmark;Germany;Netherlands;Sweden
102EUCTR2009-017490-38-DE03/05/201001/02/2010Randomized Treatment Interruption of Natalizumab - RESTORERandomized Treatment Interruption of Natalizumab - RESTORE Natalizumab is a highly efficacious therapy used in the treatment of patients with relapsing multiple sclerosis (MS).This is a prospective randomized study in subjects with relapsing forms of MS who have been receiving natalizumab treatment for at least 12 months with no MS relapses during these 12 months.
MedDRA version: 12.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: TYSABRI
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: COPAXONE
Trade Name: AVONEX
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: AVONEX
Trade Name: Urbason Forte
INN or Proposed INN: METHYLPREDNISOLONE
Other descriptive name: URBASON FORTE
Biogen IdecNULLNot RecruitingFemale: yes
Male: yes
200Germany;Spain
103EUCTR2009-012716-40-BG01/04/201008/04/2010The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trialThe Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial Relapsing-remitting multiple sclerosis
MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: PI-2301
Product Code: PI-2301
Product Name: PI-2301
Product Code: PI-2301
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Peptimmune Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 2Germany;Czech Republic;France;Estonia;Bulgaria;Poland
104EUCTR2009-018084-27-HU30/03/201001/03/2010A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3United States;Estonia;Ukraine;Lithuania;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Poland;Romania;Croatia;South Africa;Bulgaria;Georgia;Germany
105EUCTR2009-011088-35-DE24/03/201005/02/2010Pituitary adenylate cyclase activating polypeptide in stressed patients with Multiple sclerosis (MS) or clinically isolated syndrome suggestive for MS under treatment with glatiramer acetate (PACAMUS) - a randomized controlled trial - PACAMUSPituitary adenylate cyclase activating polypeptide in stressed patients with Multiple sclerosis (MS) or clinically isolated syndrome suggestive for MS under treatment with glatiramer acetate (PACAMUS) - a randomized controlled trial - PACAMUS Patients with Multiple Sclerosis (MS) or Clinically isolated syndrome suggestive for MS (CIS) are investigated. The main objective is to conserve data about changes in the VIP/PACAP (vasoactive intestinal polypaptide/pituitary adenylate cyclase activating polypeptide) system in stresses patients who start a immunomodulatory treatment with glatiramer acetate (Copaxone).Trade Name: Copaxone
Product Name: copaxone
Product Code: 52069.00.01
INN or Proposed INN: glatiramer acetate
Philipps-Universität MarburgNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2009-012716-40-CZ10/03/201008/12/2009The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trialThe Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial Relapsing-remitting multiple sclerosis
MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: PI-2301
Product Code: PI-2301
Product Name: PI-2301
Product Code: PI-2301
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Peptimmune Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 2Germany;Czech Republic;Bulgaria;France;Estonia;Poland
107EUCTR2009-012716-40-FR03/03/201028/12/2009The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trialThe Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial Relapsing-remitting multiple sclerosis
MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: PI-2301
Product Code: PI-2301
Product Name: PI-2301
Product Code: PI-2301
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Peptimmune Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 2Germany;Czech Republic;Bulgaria;Estonia;France;Poland
108NCT01058005March 201026/1/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: BG00002 (natalizumab);Drug: interferon beta-1a;Drug: glatiramer acetateBiogenElan PharmaceuticalsTerminated18 Years60 YearsAll84Phase 3United States;Australia;Canada;Czech Republic;Finland;France;Hungary;Italy;Latvia;Poland;Slovenia;Spain;Sweden
109NCT01071083March 201017/2/2010Treatment Interruption of NatalizumabRandomized Treatment Interruption of NatalizumabRelapsing Remitting Multiple SclerosisDrug: natalizumab;Drug: interferon beta 1-a;Drug: methylprednisolone;Other: IV placebo;Drug: glatiramer acetateBiogenElan PharmaceuticalsCompleted18 Years60 YearsAll175Phase 2United States;Germany;Spain
110EUCTR2009-016087-37-GB05/02/201017/03/2010A multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial - REGARD-PGxA multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial - REGARD-PGx Multiple Sclerosis
MedDRA version: 12.0Level: PTClassification code 10028245Term: Multiple sclerosis
Trade Name: Rebif
Product Name: Rebif
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
325United Kingdom;France;Ireland;Spain;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2009-012716-40-SK03/02/201019/01/2010The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trialThe Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial Relapsing-remitting multiple sclerosis
MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: PI-2301
Product Code: PI-2301
Product Name: PI-2301
Product Code: PI-2301
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Peptimmune Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 2France;Czech Republic;Estonia;Slovakia;Poland;Bulgaria;Germany
112NCT00988988February 201030/9/2009The Effects of Ethyl-Alpha-Guanido-Methyl Ethanoate on Skin Reactions From Glatiramer Acetate InjectionsThe Effects of Ethyl-alpha-Guanido-methyl Ethanoate on Skin Reactions Form Glatiramer AcetateMultiple SclerosisDrug: AGEE cream;Drug: 1% Steroid Cream;Drug: topical placebo cream with no active ingredientsUniversity of NebraskaTeva Pharmaceutical IndustriesWithdrawn19 Years65 YearsBoth0Phase 4United States
113EUCTR2009-012716-40-EE31/12/200907/12/2009The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trialThe Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial Relapsing-remitting multiple sclerosis
MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: PI-2301
Product Code: PI-2301
Product Name: PI-2301
Product Code: PI-2301
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Peptimmune Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 2Germany;Czech Republic;Bulgaria;France;Estonia;Poland
114EUCTR2009-016087-37-ES18/12/200924/11/2009Estudio farmacogenético exploratorio, multinacional, multicéntrico y con una sola toma de muestras de sangre del ensayo REGARD (REbif vs Glatiramer Acetate in Relapsing MS Disease). A multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial - REGARD-PGxEstudio farmacogenético exploratorio, multinacional, multicéntrico y con una sola toma de muestras de sangre del ensayo REGARD (REbif vs Glatiramer Acetate in Relapsing MS Disease). A multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial - REGARD-PGx Esclerosis Múltiple
MedDRA version: 12.0Level: PTClassification code 10028245Term: Multiple sclerosis
Product Name: Rebif
Product Name: Copaxone
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
325United Kingdom;France;Ireland;Spain;Italy
115NCT00910598September 200929/5/2009Optical Coherence Tomography: Glatiramer in Clinically Isolated Syndrome or Early Relapsing Remitting Multiple Sclerosis (MS)A Multicenter Longitudinal Cross-sectional Pilot Study, to Compare RNFL Thickness Measured by OCT After Treatment With Glatiramer or After no Treatment in Patients With CIS With or Without Optic Neuritis or With Early RRMSMultiple SclerosisDrug: glatiramer acetateAmphia HospitalSanofi;TEVA PharmachemieRecruiting18 Years55 YearsBoth60Phase 4Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2009-010661-23-IT30/07/200910/01/2011MITOXANTRONE/GLATIRAMER ACETATE COMBINED TREATMENT IN THE THERAPY OF SECONDARY-PROGRESSIVE MULTIPLE SCLEROSIS - aMICO STUDYMITOXANTRONE/GLATIRAMER ACETATE COMBINED TREATMENT IN THE THERAPY OF SECONDARY-PROGRESSIVE MULTIPLE SCLEROSIS - aMICO STUDY subjects affected by secondary-progressive Multiple Sclerosis
MedDRA version: 9.1Level: SOCClassification code 10029205
INN or Proposed INN: Mitoxantrone
INN or Proposed INN: Glatiramer acetate
AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLINULLNot RecruitingFemale: yes
Male: yes
Italy
117EUCTR2009-013129-41-NL20/07/200903/06/2009A multicenter open label randomized pilot study, to compare retinal nerve fiber layer thickness measured by Optical Coherence Tomography after treatment with daily 20 mg glatiramer acetate subcutaneously or after no treatment, in patients with a clinical isolated syndrome, other than optic neuritis or early relapsing remitting multiple sclerosis patients - OCTA multicenter open label randomized pilot study, to compare retinal nerve fiber layer thickness measured by Optical Coherence Tomography after treatment with daily 20 mg glatiramer acetate subcutaneously or after no treatment, in patients with a clinical isolated syndrome, other than optic neuritis or early relapsing remitting multiple sclerosis patients - OCT clinical isolated syndrome
MedDRA version: 9.1Level: LLTClassification code 10028248Term: Multiple sclerosis-like syndrome
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Amphia ZiekenhuisNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
118NCT00947752July 200925/7/2009Safety of New Formulation of Glatiramer AcetateAn Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous InjectionRelapsing Remitting Multiple SclerosisDrug: Glatiramer Acetate;Drug: Experimental Glatiramer AcetateTeva Pharmaceutical IndustriesNULLCompleted18 YearsN/AAll147Phase 3United States
119EUCTR2006-001827-21-DK06/03/200915/01/2009A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated with Copaxone for at least 3 monthsStudy Phase: III - Simvastatin/CopaxoneA Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated with Copaxone for at least 3 monthsStudy Phase: III - Simvastatin/Copaxone Multiple Sclerosis
MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis
Trade Name: Simvastatin
Trade Name: Copaxone
Product Name: Glatiramer acetate
Glostrup Hospital, Dep. of NeurologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Denmark
120NCT00819000December 20087/1/2009Therapy Optimization in Multiple Sclerosis (MS)TOP MS is a Study of Multiple Sclerosis Disease Management in Collaboration With Specialty PharmaciesMultiple SclerosisDrug: Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1bTeva Neuroscience, Inc.NULLCompleted18 YearsN/ABoth2878N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT00819195December 200816/12/2008Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple SclerosisAnti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple SclerosisMultiple SclerosisDrug: Glatiramer acetateUniversity of California, San FranciscoNational Multiple Sclerosis Society;Teva Neuroscience, Inc.Completed18 Years55 YearsBoth17N/AUnited States
122EUCTR2006-003697-10-BG14/08/200814/06/2008A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/AA Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
Product Name: BG00012
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: Glatiramer Acetate
Biogen Idec Ltd.NULLNot RecruitingFemale: yes
Male: yes
1232Germany;Czech Republic;Estonia;Bulgaria;Ireland;Spain;Greece;Latvia
123EUCTR2007-003997-24-GB08/07/200820/08/2007Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapsesLong-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses Multiple Sclerosis
MedDRA version: 12.1Level: LLTClassification code 10028245Term: Multiple sclerosis
Product Name: Teriflunomide
Product Code: HMR 1726D
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726D
INN or Proposed INN: Teriflunomide
Sanofi-Aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
240United Kingdom;Spain;Italy;Austria
124EUCTR2007-003997-24-IT05/06/200813/06/2008Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses - NDLong-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses - ND Multiple Sclerosis
MedDRA version: 9.1Level: LLTClassification code 10048393Term: Multiple sclerosis relapse
Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Sanofi-Aventis recherche & de'veloppementNULLNot RecruitingFemale: yes
Male: yes
240United Kingdom;Spain;Italy;Austria
125EUCTR2007-003997-24-ES26/11/200715/10/2007Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrenciasLong-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias Multiple Sclerosis.-----------------------Esclerosis Múltiple.Product Name: Teriflunomide
Product Code: HMR 1726D
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726D
INN or Proposed INN: Teriflunomide
Sanofi-Aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
240United Kingdom;Spain;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2006-003697-10-GR30/10/200731/05/2007A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/AA Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: BG00012
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: Glatiramer Acetate
Biogen Idec Ltd.NULLNot RecruitingFemale: yes
Male: yes
1232Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia
127EUCTR2008-007162-32-IT30/10/200706/11/2008ADVANCED MRI STUDY ON INFLAMMATORY AND DEGENRATIVE DAMAGE IN MULTIPLE SCLEROSIS - RMaIDSMADVANCED MRI STUDY ON INFLAMMATORY AND DEGENRATIVE DAMAGE IN MULTIPLE SCLEROSIS - RMaIDSM Multiple Sclerosis
MedDRA version: 9.1Level: SOCClassification code 10029205Term: Nervous system disorders
Trade Name: COPAXONE
INN or Proposed INN: Glatiramer acetate
Trade Name: AVONEX
INN or Proposed INN: Interferon beta-1a
ISTITUTO C. MONDINONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
128EUCTR2007-003997-24-AT14/10/200721/09/2007Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapsesLong-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses Multiple SclerosisProduct Name: Teriflunomide
Product Code: HMR 1726D
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726D
INN or Proposed INN: Teriflunomide
Sanofi-Aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
240United Kingdom;Spain;Italy;Austria
129EUCTR2006-003697-10-DE04/10/200706/04/2009A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/AA Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: BG00012
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: Glatiramer Acetate
Biogen Idec Ltd.NULLNot RecruitingFemale: yes
Male: yes
1232Czech Republic;Germany;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia
130NCT00811395October 200718/12/2008Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple SclerosisLong-term Extension of the Multinational, Double-blind, Placebo Controlled Studies PDY6045 and PDY6046 to Document the Safety of Teriflunomide When Added to Treatment With Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis With RelapsesMultiple SclerosisDrug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-ß [IFN-ß];Drug: Glatiramer Acetate [GA]SanofiNULLCompleted18 Years55 YearsAll182Phase 2United States;Austria;Canada;Germany;Italy;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2006-004893-29-IT24/09/200724/07/2007A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis - NDA randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis - ND multiple sclerosis
MedDRA version: 9.1Level: LLTClassification code 10048393Term: Multiple sclerosis relapse
Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Sanofi-aventis U.S. Inc.NULLNot RecruitingFemale: yes
Male: yes
120Germany;United Kingdom;Italy;Austria
132EUCTR2006-003697-10-EE18/09/200712/06/2007A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/AA Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A Relapsing-Remitting Multiple SclerosisEsclerosis Múltiple recidivante-remitente
MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: BG00012
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Copaxone
Product Name: Copaxone
Biogen Idec Ltd.NULLNot RecruitingFemale: yes
Male: yes
1232Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia
133NCT00937157September 20079/7/2009Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)Comparison of Standard 1.5 Versus 3T Optimized Protocols in Patients Treated With Glatiramer Acetate. A Conventional and Non-conventional MRI StudyMultiple SclerosisDrug: CopaxoneUniversity at BuffaloTeva Neuroscience, Inc.Completed18 Years65 YearsAll12N/AUnited States
134EUCTR2006-003697-10-ES29/08/200728/02/2007A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisEstudio aleatorizado, multicéntrico, controlado con placebo y de comparación con un fármaco activo de referencia (glatiramer acetato) para evaluar la eficacia y la seguridad de BG00012 en pacientes con esclerosis múltiple recidivante-remitente - N/AA Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisEstudio aleatorizado, multicéntrico, controlado con placebo y de comparación con un fármaco activo de referencia (glatiramer acetato) para evaluar la eficacia y la seguridad de BG00012 en pacientes con esclerosis múltiple recidivante-remitente - N/A Relapsing-Remitting Multiple SclerosisEsclerosis Múltiple recidivante-remitente
MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: BG00012
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: glatiramer acetate
Biogen Idec Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1232Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia
135EUCTR2006-003697-10-LV22/08/200726/07/2007A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/AA Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: BG00012
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec Ltd.NULLNot RecruitingFemale: yes
Male: yes
1232Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2006-004893-29-GB25/07/200717/12/2006A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosisA randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis Multiple sclerosisSanofi-aventis U.S. Inc.NULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noAustria;Germany;Italy;United Kingdom
137EUCTR2006-003697-10-BE13/07/200723/02/2007A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/AA Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: BG00012
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec Ltd.NULLNot RecruitingFemale: yes
Male: yes
1232Phase 3Estonia;Czech Republic;Greece;Spain;Belgium;Ireland;Bulgaria;Germany;Latvia
138EUCTR2006-003697-10-IE04/07/200720/03/2007A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/AA Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: BG00012
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: Glatiramer Acetate
Biogen Idec Ltd.NULLNot RecruitingFemale: yes
Male: yes
1232Germany;Czech Republic;Bulgaria;Estonia;Spain;Ireland;Greece;Latvia
139EUCTR2004-000463-94-HU03/07/200712/07/2004A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS).A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). Relapsing-remitting multiple sclerosis (R-R MS)
MedDRA version: 5.1Level: PTClassification code 10028245
Product Name: Glatiramer acetate 150mg enteric coated tablets
INN or Proposed INN: Glatiramer Acetate
Other descriptive name: COP-1/Copolymer-1
TEVA Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
25Hungary;Italy
140NCT00451451June 200721/3/2007Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple SclerosisA Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: BG00012;Drug: Placebo;Drug: Glatiramer AcetateBiogenNULLCompleted18 Years55 YearsAll1417Phase 3United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Costa Rica;Croatia;Czech Republic;Estonia;France;Germany;Greece;India;Ireland;Israel;Latvia;Macedonia, The Former Yugoslav Republic of;Mexico;Moldova, Republic of;New Zealand;Poland;Puerto Rico;Romania;Serbia;Slovakia;Spain;Ukraine;Australia;Italy;Kazakhstan;Lithuania;Russian Federation
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2006-003697-10-CZ13/04/200723/02/2007A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/AA Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A Relapsing-Remitting Multiple Sclerosis
MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis
Product Name: BG00012
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: Glatiramer Acetate
Biogen Idec Ltd.NULLNot RecruitingFemale: yes
Male: yes
1232Germany;Czech Republic;Bulgaria;Estonia;Ireland;Spain;Greece;Latvia
142NCT00475865April 200718/5/2007Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple SclerosisA Randomized, Multinational, Double-blind, Placebo-controlled, Parallel-group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Glatiramer Acetate in Subjects With Multiple SclerosisMultiple SclerosisDrug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Glatiramer Acetate (GA)SanofiNULLCompleted18 Years55 YearsAll123Phase 2United States;Austria;Canada;Germany;Italy;United Kingdom
143EUCTR2006-004893-29-AT19/03/200708/03/2007A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosisA randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis Multiple sclerosisProduct Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Sanofi-aventis U.S. Inc.NULLNot RecruitingFemale: yes
Male: yes
120Germany;United Kingdom;Italy;Austria
144EUCTR2006-002037-20-EE02/02/200704/12/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1Level: PTClassification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: glatiramer acetate
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
145EUCTR2006-002037-20-LT30/11/200609/10/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1Level: PTClassification code 10028245Term: Multiple sclerosis
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Trade Name: Copaxone 20mg/ml Solution for Injection, pre-filled syringe
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: glatiramer acetate
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2006-002037-20-CZ13/10/200628/08/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1Level: PTClassification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: n.a.
Trade Name: Copaxone 20 mg/ml, Solution for Injection, pre-filled syringes
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: n.a.
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;United Kingdom;Czech Republic;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
147EUCTR2006-002037-20-BE27/09/200619/07/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1Level: PTClassification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: n.a.
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: n.a.
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
148EUCTR2006-002037-20-GB07/09/200623/07/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1Level: PTClassification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: n.a.
Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: n.a.
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
149EUCTR2006-002037-20-DE07/09/200620/10/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1Level: PTClassification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: n.a.
Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: n.a.
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Czech Republic;United Kingdom;Germany;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
150EUCTR2006-002037-20-ES06/09/200607/07/2006 A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1 Level: PT Classification code 10028245
Teva Pharmaceutical Industries, Ltd.NULLNot Recruiting Female: yes
Male: yes
980 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noEstonia;Czech Republic;Hungary;Finland;Belgium;Spain;Lithuania;Germany;Latvia;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2006-002037-20-LV06/09/200623/08/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1Level: PTClassification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: glatiramer acetate
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: glatiramer acetate
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
152NCT00398528September 20069/11/2006An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple SclerosisAn fMRI Study of Treatment Optimization Recommendations Comparing Patients Changing Treatment From Glatiramer Acetate 20 mg qd SC (Copaxone®) to IFN-ß-1a 30 Mcg qw IM (Avonex®) to Those Changing From to IFN-ß-1a 30 Mcg qw IM (Avonex®) to Glatiramer Acetate 20 mg qd SC (Copaxone®) in a Multicenter Study of Patients With Relapsing Remitting Multiple Sclerosis Currently on Disease-Modifying Therapy.Relapsing-Remitting Multiple SclerosisDrug: Glatiramer acetate, (Copaxone®);Drug: IFN-ß-1a, (Avonex®)NeurognosticsNULLTerminated18 Years65 YearsBoth48United States
153NCT00337779August 200614/6/2006Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind Study to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to That of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects With Relapsing Remitting (R-R) Multiple Sclerosis (MS)Relapsing Remitting Multiple SclerosisDrug: Glatiramer Acetate (GA) 40 mg;Drug: glatiramer acetate 20 mgTeva Pharmaceutical IndustriesNULLCompleted18 Years55 YearsAll1155Phase 3Argentina;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Spain;United Kingdom;United States
154EUCTR2006-002037-20-HU27/07/200623/05/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1Level: PTClassification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: n.a.
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: n.a.
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
155EUCTR2006-002037-20-IT12/07/200630/08/2006A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind, Study, to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects with Relapsing Remitting R-R Multiple Sclerosis MS . - FORTEA Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind, Study, to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects with Relapsing Remitting R-R Multiple Sclerosis MS . - FORTE Patients with Relapsing - Remitting Multiple Sclerosis.
MedDRA version: 6.1Level: PTClassification code 10028245
Product Name: 40 mg Glatiramer acetato
Product Code: 40 mg GA
INN or Proposed INN: Glatiramer acetate
Trade Name: COPAXONE*SC 28SIR 20MG/ML
INN or Proposed INN: Glatiramer acetate
Teva Pharmaceuticals Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2006-002037-20-FI12/07/200615/06/2006A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTEA multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1Level: PTClassification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: n.a.
Trade Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: n.a.
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Phase 3Estonia;Czech Republic;Hungary;Finland;Belgium;Spain;Lithuania;Germany;Latvia;Italy;United Kingdom
157NCT00331747May 200630/5/2006Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer AcetateThree Dimensional Gait Evaluation in Relapsing Remitting Multiple Sclerosis Patients Treated With Glatiramer AcetateMultiple SclerosisDrug: Glatiramer acetateSheba Medical CenterNULLRecruiting18 YearsN/ABoth20N/AIsrael
158EUCTR2005-003930-16-SE19/01/200621/11/2005A 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: 7.0Level: PTClassification code 10028425
Product Name: Simvastatin Alternova
INN or Proposed INN: Simvastatin
Biogen Idec A/SNULLNot RecruitingFemale: yes
Male: yes
380Finland;Sweden
159EUCTR2005-003930-16-FI05/01/200629/11/2005A 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: 7.0Level: PTClassification 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
160EUCTR2005-003930-16-DK09/12/200505/12/2005A 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: 7.0Level: PTClassification code 10028425
Product Name: Simvastatin Alternova
INN or Proposed INN: Simvastatin
Biogen Idec A/SNULLNot RecruitingFemale: yes
Male: yes
380Finland;Denmark;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT00239993August 200522/9/2005A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®.Multiple SclerosisDrug: glatiramer acetate;Procedure: Warm compress prior to injection of glatiramer acetateTeva Neuroscience, Inc.NULLCompleted18 Years55 YearsAll50Phase 4United States
162EUCTR2004-004903-39-GB26/07/200514/06/2005A pilot multi-centre randomised controlled trial of sequential treatment with Mitoxantrone and Glatiramer Acetate vs. Interferon Beta-1a in early active relapsing remitting Multiple Sclerosis. - UNKEMPTA pilot multi-centre randomised controlled trial of sequential treatment with Mitoxantrone and Glatiramer Acetate vs. Interferon Beta-1a in early active relapsing remitting Multiple Sclerosis. - UNKEMPT Early, active relapsing remitting Multiple Sclerosis (RRMS)The Walton Centre for Neurology and NeurosurgeryNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesUnited Kingdom
163NCT00203047January 200513/9/2005Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer AcetateA Multi-Centered, Randomized, Double-Blind, Placebo Controlled Study Assessing the Add-on Effect of Oral Steroids in Relapsing Remitting Multiple Sclerosis Subjects Treated With Glatiramer Acetate (GA)Relapsing Remitting Multiple SclerosisDrug: Glatiramer Acetate;Drug: Placebo;Drug: PrednisoneTeva Pharmaceutical IndustriesNULLTerminated18 Years55 YearsAll414Phase 4Canada;United States
164NCT00211887January 200513/9/2005Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRxA Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx)Relapsing Remitting Multiple SclerosisDrug: Interferon beta 1-a;Drug: glatiramer acetate;Other: placeboFred LublinNational Institute of Neurological Disorders and Stroke (NINDS)Completed18 Years60 YearsAll1008Phase 3United States;Canada
165NCT00203099December 200413/9/2005Safety and Efficacy Study of Copaxone Administered in Combination With N-AcetylcysteineA Pilot, Multicenter, Open-label, One-group Study to Explore the Efficacy, Tolerability and Safety of the Combination of Glatiramer Acetate (GA) and N-Acetylcysteine (NAC) in Subjects With Relapsing Remitting Multiple Sclerosis (RR-MS)Relapse Remitting Multiple SclerosisDrug: Glatiramer Acetate, N-AcetylcysteineTeva Pharmaceutical IndustriesNULLCompleted18 Years50 YearsBoth18Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166NCT00101959November 200418/1/2005Implementation Study of Treatment Optimization Recommendations on Relapsing-Remitting Multiple Sclerosis (RR MS) SubjectsAn Implementation Study of Treatment Optimization Recommendations Comparing Subjects Continuing Treatment With IFN-ß-1a 30 Mcg qw IM (Avonex®) or Glatiramer Acetate 20 mg qd SC (Copaxone®) to Those Randomized to IFN-ß-1a 44 Mcg Tiw SC (Rebif®), in a Multicenter Study of Subjects With Relapsing Remitting Multiple Sclerosis Currently on Disease-Modifying TherapyRelapsing-Remitting Multiple SclerosisDrug: RebifEMD SeronoNULLWithdrawn18 Years60 YearsBoth0Phase 4United States
167EUCTR2004-000759-40-IT22/10/200415/02/2005A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 15 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis.A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 15 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. Subject with relapsing remitting Multiple Sclerosis. Subject must have at least one documented relapse within one year prior to screening visit.
MedDRA version: 6.1Level: PTClassification code 10028245
Product Name: glatiramer acetate
Product Code: TV-5010
INN or Proposed INN: Glatiramer acetate
TEVANULLNot RecruitingFemale: yes
Male: yes
25Italy
168EUCTR2004-000463-94-IT11/10/200416/02/2005A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS).A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 600mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). Subject with relapsing remitting multiple sclerosis. Subject must have at least one documented relapse within one year prior to screening visit
MedDRA version: 6.1Level: PTClassification code 10028245
Product Name: glatiramer acetate
Product Code: GA
INN or Proposed INN: Glatiramer acetate
TEVANULLNot RecruitingFemale: yes
Male: yes
25Hungary;Italy
169NCT00240032October 200413/10/2005A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe.Multiple SclerosisDrug: glatiramer acetate injection with oral cetirizine hydrochloride;Drug: glatiramer acetate with placeboTeva Pharmaceutical IndustriesNULLCompleted18 YearsN/ABoth80Phase 4United States
170EUCTR2004-000762-13-IT31/08/200431/08/2012A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 30 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis.A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of 30 mg TV-5010 administered once weekly in subjects with relapsing-remitting multiple sclerosis. Subject with relapsing remitting Multiple Sclerosis. Subject must have at least one documented relapse within one year prior to screening visit.
MedDRA version: 15.0Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Glatiramer acetate
Product Code: TV-5010
INN or Proposed INN: Glatiramer acetate
TEVA ITALIA srlNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
7Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2004-000462-13-IT30/07/200417/09/2004A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS).A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). Subjects with Relapsing-Remitting Multiple Sclerosis.Subjects must have had at least one documented relapse within one year prior to screening visit
MedDRA version: 6.1Level: PTClassification code 10028245
Product Name: glatiramer acetate
Product Code: GA
INN or Proposed INN: Glatiramer acetate
TEVANULLNot RecruitingFemale: yes
Male: yes
Hungary;Italy
172EUCTR2004-000462-13-HU12/07/200412/07/2004A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS).A pilot, multicenter, open-label, one-group study to explore the efficacy, tolerability and safety of an oral once-daily 300mg dose of glatiramer acetate (GA) in subjects with Relapsing Remitting (R-R) Multiple Sclerosis (MS). Relapsing-remitting multiple sclerosis (R-R MS)
MedDRA version: 5.1Level: PTClassification code 10028245
Product Name: Glatiramer acetate 150mg enteric-coated (gastro-resistant) tablets
INN or Proposed INN: Glatiramer Acetate
Other descriptive name: COP-1/Copolymer-1
TEVA Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
25Hungary;Italy
173NCT00202995July 200413/9/2005Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMSA Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis PatientsRelapsing Remitting Multiple SclerosisDrug: Glatiramer Acetate;Drug: Betaseron;Drug: RebifTeva Pharmaceutical IndustriesNULLTerminated18 Years50 YearsBoth91Phase 4United States;Canada
174NCT00203112June 200413/9/2005Safety and Efficacy Study of Copaxone Administered in Combination With MinocyclineA Multi-Centered, Randomized, Double-Blind, Placebo-Controlled, Parallel Study Assessing the Add-on Effect of Minocycline in Relapsing-Remitting Multiple Sclerosis (RR-MS) Subjects Treated With Glatiramer Acetate (GA).Relapse Remitting Multiple SclerosisDrug: glatiramer acetate with minocycline;Drug: Glatiramer acetate with placeboTeva Pharmaceutical IndustriesNULLCompleted18 Years50 YearsBoth44Phase 2Canada
175NCT00078338March 200423/2/2004Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple SclerosisPhase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: Human interferon beta-1a and glatiramer acetateEMD SeronoPfizerCompleted18 Years60 YearsBoth764Phase 4United States;Argentina;Austria;Brazil;France;Germany;Italy;Netherlands;Russian Federation;Spain;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT00666224January 200422/4/2008Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated SyndromeA Multinational, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting With Clinically Isolated Syndrome (CIS)Multiple SclerosisDrug: Glatiramer Acetate (DB);Drug: Placebo;Drug: Glatiramer Acetate (OL)Teva Pharmaceutical IndustriesNULLCompleted18 Years45 YearsAll481Phase 3Argentina;Australia;Austria;Denmark;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Romania;Spain;Sweden;United Kingdom;United States
177NCT00202982August 200312/9/2005A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved DoseA Multi-Center, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy, Tolerability and Safety of 40 mg of Copaxone in the Treatment of Relapsing-Remitting Multiple Sclerosis PatientsRelapse-Remitting Multiple SclerosisDrug: glatiramer acetate 20 mg;Drug: glatiramer acetate 40 mgTeva Pharmaceutical IndustriesNULLCompleted18 Years50 YearsBoth90Phase 2United States
178NCT00097760June 200330/11/2004Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple SclerosisSafety Study of Natalizumab in Combination With Glatiramer Acetate (GA)Multiple Sclerosis, Relapsing-RemittingDrug: Natalizumab;Drug: PlaceboBiogen IdecElan PharmaceuticalsCompleted18 Years55 YearsBoth110Phase 2NULL
179NCT00203073June 200313/9/2005A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis.Relapsing Remitting Multiple SclerosisDrug: glatiramer acetate 20 mg;Drug: glatiramer acetate 20 mg, with mitoxantroneTeva Pharmaceutical IndustriesNULLCompleted18 Years55 YearsBoth40Phase 2United States;Canada
180NCT00267319June 200319/12/2005FOCUS Fatigue Outcome in Copaxone USersFatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: Glatiramer acetateSanofiNULLCompleted18 YearsN/ABoth111Phase 4Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT00039988November 200118/6/2002Treatment of Multiple Sclerosis With Copaxone and AlbuterolTreatment of Multiple Sclerosis With Copaxone (Glatiramer Acetate) and AlbuterolAutoimmune Diseases;Multiple SclerosisDrug: Glatiramer acetate;Drug: Albuterol;Drug: Albuterol placeboNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceCompleted18 Years55 YearsBoth40N/AUnited States
182NCT00203021March 26, 199412/9/2005Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and EffectivenessOpen Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With CopaxoneRelapsing-Remitting Multiple SclerosisDrug: Glatiramer acetateTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 YearsN/AAll208Phase 4United States
183EUCTR2017-005129-18-IT26/03/2018Clinical trial to evaluate the effectiveness and safety of IFN beta-1a (IFN beta-1a), injected once a week via intramuscolar (i.m.), and glatiramer-acetate (GA) in children/adolescent patients with multiple sclerosis.Multi-centre, randomised, open label pragmatic trial to compare the effectiveness and safety of interferon beta-1a (IFN-beta-1a) weekly i.m. and glatiramer-acetate (GA) in paediatric patients affected by multiple sclerosis. Relapsing-remitting multiple sclerosis with paediatric onset
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 40 mg/ml solution for injection, pre-filled syringe
INN or Proposed INN: Glatiramer Acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: AVONEX 30 µg/0,5 ml solution for injection
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Università degli Studi Aldo MoroNULLNAFemale: yes
Male: yes
142Phase 3Italy
184EUCTR2006-004893-29-DE06/02/2007A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosisA randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis Multiple sclerosisProduct Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Product Name: teriflunomide
Product Code: HMR1726D
INN or Proposed INN: teriflunomide
Sanofi-aventis U.S. Inc.NULLNot RecruitingFemale: yes
Male: yes
120Austria;Germany;Italy;United Kingdom

96. クローン病 [臨床試験数:2,209,薬物数:1,276(DrugBank:240),標的遺伝子数:166,標的パスウェイ数:210
Searched query = "Crohn disease", "Terminal ileitis"
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.
1 / 2,209 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00731172September 20086/8/2008A Double Blind Placebo Control Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Crohn's DiseaseA Pilot Single Center,Randomized,Double Blind Placebo Controlled Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Inducing Remission in Patients With Moderately Active Crohn's Disease.Crohns DiseaseDrug: glatiramer acetate;Drug: placeboTel-Aviv Sourasky Medical CenterTeva Pharmaceutical Industries;Given Imaging Ltd.Recruiting18 Years70 YearsBoth50Phase 2Israel

156. レット症候群 [臨床試験数:36,薬物数:49(DrugBank:19),標的遺伝子数:77,標的パスウェイ数:112
Searched query = "Rett syndrome"
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.
2 / 36 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02023424January 201423/12/2013An Open Label, Exploratory Study to Investigate the Treatment Effect of Glatiramer Acetate on Girls Woth Rett SyndromeAn Open Label, Exploratory Study to Investigate the Treatment Effect og Glatiramer Acetate (Copaxone ®) on Girls Woth Rett SyndromeRett SyndromeDrug: Glatiramer Acetate (Copaxone®)Sheba Medical CenterNULLRecruiting6 Years15 YearsFemale10Phase 1Israel
2NCT02153723August 201326/5/2014Pharmacological Treatment of Rett Syndrome With Glatiramer Acetate (Copaxone)Pharmacological Treatment of Rett Syndrome With Glatiramer Acetate (Copaxone)Rett SyndromeDrug: Glatiramer AcetateMontefiore Medical CenterRett Syndrome Research TrustCompleted10 YearsN/AFemale10Phase 2United States