13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
臨床試験数 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04777539 (ClinicalTrials.gov) | June 17, 2021 | 23/2/2021 | Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple Sclerosis | Assessing the Safety and Benefit of Home-hospitalization Program in the Management of Natalizumab (Tysabri®) Medication in Multiple Sclerosis | Multiple Sclerosis (MS) | Other: At-home natalizumab treated MS patient | Nantes University Hospital | Rennes University Hospital | Recruiting | 18 Years | N/A | All | 315 | France | |
| 2 | NCT04565431 (ClinicalTrials.gov) | March 19, 2021 | 25/8/2020 | Examining Effects of Tysabri on Cognitive Fatigue Using fMRI | Biomarker for Cognitive Fatigue Using Functional Imaging in Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Tysabri | Kessler Foundation | St. Barnabas Medical Center | Recruiting | 18 Years | 64 Years | All | 25 | United States | |
| 3 | EUCTR2019-002566-13-NL (EUCTR) | 19/12/2019 | 29/10/2019 | Personalizing the treatment with natalizumab in patients with multiple sclerosis | Personalized extended interval dosing of natalizumab in relapsing remitting multiple sclerosis - NEXT-MS | Relapsing remitting multiple sclerosis MedDRA version: 20.1;Level: LLT;Classification code 10070425;Term: Multiple sclerosis exacerbation;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Name: natalizumab | Amsterdam University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 4 | NCT04115488 (ClinicalTrials.gov) | October 1, 2019 | 10/9/2019 | Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® | Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) | Relapsing-Remitting Multiple Sclerosis (RRMS) | Biological: Intravenous (IV) infusions | Polpharma Biologics S.A. | NULL | Active, not recruiting | 18 Years | 60 Years | All | 260 | Phase 3 | Belarus;Croatia;Georgia;Moldova, Republic of;Poland;Serbia;Ukraine |
| 5 | EUCTR2018-004751-20-HR (EUCTR) | 18/09/2019 | 02/12/2019 | A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple Sclerosis | Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: PB006 INN or Proposed INN: NATALIZUMAB Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: NATALIZUMAB | Polpharma Biologics S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 3 | Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of | ||
| 6 | EUCTR2018-004751-20-PL (EUCTR) | 22/07/2019 | 25/04/2019 | A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple Sclerosis | Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: PB006 INN or Proposed INN: NATALIZUMAB Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: NATALIZUMAB | Polpharma Biologics S.A. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of | ||
| 7 | EUCTR2018-002145-11-GB (EUCTR) | 21/03/2019 | 11/10/2018 | A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab Administration | A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration - BIIB 101MS329 | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI Product Name: TYSABRI INN or Proposed INN: NATALIZUMAB Trade Name: TYSABRI Product Name: TYSABRI INN or Proposed INN: NATALIZUMAB Other descriptive name: BG00002 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 480 | Phase 3 | United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;New Zealand;Italy;United Kingdom | ||
| 8 | EUCTR2018-002145-11-NL (EUCTR) | 14/03/2019 | 05/11/2018 | A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab Administration | A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: BG00002 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 480 | Phase 3 | United States;France;Canada;Spain;Belgium;Australia;Israel;Germany;Netherlands;United Kingdom;New Zealand;Italy | ||
| 9 | EUCTR2018-002145-11-FR (EUCTR) | 08/03/2019 | 31/10/2018 | A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment | A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - NOVA | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 480 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2018-002145-11-DE (EUCTR) | 15/02/2019 | 17/10/2018 | A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment | A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | France;United States;Canada;Spain;Belgium;Australia;Israel;Netherlands;New Zealand;Italy;United Kingdom;Germany | ||
| 11 | EUCTR2018-002145-11-ES (EUCTR) | 02/01/2019 | 05/11/2018 | A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment | A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 480 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;New Zealand;Italy;United Kingdom | ||
| 12 | EUCTR2018-001292-21-FR (EUCTR) | 27/07/2018 | 05/06/2018 | Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years | Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years | Secondary Progressive Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AVONEX Product Name: BETAFERON Product Code: L03 AB 08 Product Name: EXTAVIA Product Name: REBIF Product Name: PLEDIGRY Product Name: COPAXONE Product Name: AUBAGIO Product Name: TECFIDERA Product Name: GILENYA Product Name: TYSABRI Product Name: IMUREL Product Name: NOVATREX Product Name: CELLCEPT Product Name: ENDOXAN | CHU de Rennes | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 13 | NCT03399981 (ClinicalTrials.gov) | January 24, 2018 | 9/1/2018 | Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries | An Observational Study Utilising Data From the US Tysabri TOUCH Programme and Select EU MS Registries to Estimate the Risk of Progressive Multifocal Leukoencephalopathy (PML) and Other Serious Opportunistic Infections Among Patients Who Were Exposed to an MS Disease Modifying Treatment Prior to Treatment With Tysabri | Progressive Multifocal Leukoencephalopathy | Biological: Tysabri | Biogen | NULL | Active, not recruiting | N/A | N/A | All | 72600 | United States | |
| 14 | EUCTR2017-002634-24-SE (EUCTR) | 29/09/2017 | 06/07/2017 | MultipleMS – 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 Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | Sweden | ||
| 15 | EUCTR2016-003587-39-SE (EUCTR) | 22/05/2017 | 23/03/2017 | This 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 Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 3700 | Phase 4 | Sweden | ||
| 16 | EUCTR2016-000345-31-NL (EUCTR) | 30/09/2016 | 11/04/2016 | Reduce the number of natalizumab infusions in patients with multiple sclerosis | Towards personalized dosing of natalizumab in multiple sclerosis - Personalised Dosing of Natalizumab in Multiple Sclerosis (The PDNMS trial) | multiple sclerosis MedDRA version: 18.1;Level: LLT;Classification code 10070425;Term: Multiple sclerosis exacerbation;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: tysabri Product Name: natalizumab INN or Proposed INN: NATALIZUMAB | VU medical center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Netherlands | ||
| 17 | EUCTR2013-004622-29-DE (EUCTR) | 23/02/2015 | 11/11/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 18 | EUCTR2013-005586-39-DE (EUCTR) | 29/01/2015 | 02/09/2014 | Natalizumab (BG00002) as an Efficacy Switch in Subjects with Relapsing Multiple Sclerosis (MS) after Failure on Other Therapies | A Phase 4 Multicenter, Open-Label, Single Arm Study toEvaluate Switching from BRACET/Gilenya® to Natalizumabin Subjects with Relapsing Forms of Multiple Sclerosis (MS) | Multiple Sclerosis (MS) MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United States;Germany;Italy | ||
| 19 | EUCTR2013-004622-29-DK (EUCTR) | 29/01/2015 | 04/12/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Australia;Denmark;Germany;Italy;United Kingdom;Sweden | ||
| 20 | EUCTR2013-004622-29-SE (EUCTR) | 30/12/2014 | 29/09/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 21 | EUCTR2013-004622-29-ES (EUCTR) | 03/12/2014 | 03/10/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 22 | EUCTR2013-004622-29-GB (EUCTR) | 20/11/2014 | 28/08/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 23 | EUCTR2013-004622-29-IT (EUCTR) | 10/11/2014 | 05/08/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Italy;Sweden | |||
| 24 | EUCTR2013-004622-29-CZ (EUCTR) | 31/10/2014 | 13/08/2014 | Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects | A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects | Multiple Sclerosis (MS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 4 | France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden | ||
| 25 | EUCTR2014-003669-97-BE (EUCTR) | 27/10/2014 | 02/09/2014 | A safety study for patients with Relapsing Forms of Multiple Sclerosis who participated STRATA. | A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA. | Relapsing Forms of Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: NATALIZUMAB | Biogen Idec | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 4 | Belgium | ||
| 26 | EUCTR2014-003209-14-FR (EUCTR) | 01/09/2014 | 18/06/2015 | ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS | ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS - TYSADIFF | MULTIPLE SCLEROSIS;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI 300 mg solution à diluer pour perfusion INN or Proposed INN: NATALIZUMAB | Hôpitaux Universitaires de Strasbourg | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 27 | NCT02159573 (ClinicalTrials.gov) | July 2014 | 19/5/2014 | Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab) | A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate) | Relapsing-Remitting Multiple Sclerosis | Biological: natalizumab;Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | Both | 530 | N/A | United States |
| 28 | EUCTR2013-004616-21-DE (EUCTR) | 13/03/2014 | 04/02/2014 | A study to assess immune function and typical disease characteristics in patients with multiple sclerosis, when switching from the medication Natalizumab to the medication Gilenya. | A 32-week, monocentric, exploratory, single arm study to assess immune function and MRI disease activity in patients with relapsing remitting multiple sclerosis (RRMS) transferred from previous treatment with Natalizumab to Gilenya® (Fingolimod) - ToFingo Successor | relapsing remitting multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB | Universitätsklinikum Münster | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 29 | NCT02137109 (ClinicalTrials.gov) | March 2014 | 1/5/2014 | Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri | Meta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Completed | N/A | 18 Years | Both | 400 | N/A | NULL |
| 30 | EUCTR2013-004626-28-FI (EUCTR) | 20/12/2013 | 20/11/2013 | Does targeting of S1P receptors reduce microglial activation in multiple sclerosis? | Does targeting of S1P receptors reduce microglial activation in multiple sclerosis? | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: REBIF Product Name: beetainterferoni -1a Other descriptive name: INTERFERON BETA-1A Trade Name: Gilenya Product Name: Fingolimodi Other descriptive name: FINGOLIMOD Trade Name: Avonex Trade Name: Betaferon Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Lemtrada Other descriptive name: ALEMTUZUMAB | Turku University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 4 | Finland | ||
| 31 | NCT04832399 (ClinicalTrials.gov) | November 12, 2013 | 16/3/2021 | Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants | Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients - TYPIFI (Tysabri Patient Initiation After Failure of the Initial DMT) | Relapsing Remitting Multiple Sclerosis | Drug: Natalizumab | Biogen | NULL | Recruiting | 18 Years | 55 Years | All | 60 | Portugal | |
| 32 | EUCTR2012-004165-41-GB (EUCTR) | 04/11/2013 | 19/09/2013 | Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study | Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - Hematopoietic Stem Cell Therapy for Inflammatory MS | Inflammatory Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: natalizumab Trade Name: Fingolimod Product Name: Gilenya INN or Proposed INN: Fingolimod Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG-12 120 INN or Proposed INN: dimethyl fumarate | Northwestern University | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | United States;United Kingdom | ||
| 33 | NCT03133403 (ClinicalTrials.gov) | November 2013 | 21/4/2016 | Hematopoietic Stem Cell Therapy for Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy | Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Tecfidera (BG12);Drug: Gilenya;Drug: Tysabri®;Drug: Avonex/Betaseron/Copaxone/Rebif;Procedure: Hematopoietic stem cell transplantation (HSCT) | Sheffield Teaching Hospitals NHS Foundation Trust | NULL | Recruiting | 18 Years | 55 Years | All | 5 | Phase 2/Phase 3 | United Kingdom |
| 34 | EUCTR2012-005082-13-IT (EUCTR) | 02/04/2013 | 18/02/2013 | A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple Sclerosis | A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 1 | Italy | ||
| 35 | EUCTR2011-001437-16-DE (EUCTR) | 19/09/2012 | 09/02/2012 | A 3 year study to determine if optical coherence tomography can be used to measure disease progression in patients with multiple sclerosis | A 3-year, multi-center study to evaluate optical coherence tomography as an outcome measure in patients with multiple sclerosis - | multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Germany;Switzerland;Netherlands;France;Italy;Austria;Australia;Czech Republic;United Kingdom;Canada;Denmark;Spain;United States;Poland | |||
| 36 | EUCTR2010-021978-11-IE (EUCTR) | 06/07/2012 | 14/05/2012 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | Phase 3 | United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 37 | NCT02142205 (ClinicalTrials.gov) | May 2012 | 16/5/2014 | Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Participants With Relapsing Remitting Multiple Sclerosis (RRMS) | A Prospective, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety and Efficacy in RUSsian RRMS Patients on One Year Treatment With Natalizumab (TYSabri®). | Relapsing-Remitting Multiple Sclerosis | Biological: BG00002 | Biogen Idec | Biogen Idec International GmbH | Completed | 18 Years | 60 Years | Both | 100 | Phase 4 | Russian Federation |
| 38 | NCT01591551 (ClinicalTrials.gov) | March 2012 | 22/4/2012 | NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness | NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Relapsing Forms of Multiple Sclerosis Experiencing Fatigue or Sleepiness | Multiple Sclerosis, Relapsing-Remitting | Drug: Natalizumab (Tysabri) | Cornerstone Health Care, PA | Biogen Idec | Completed | 18 Years | 65 Years | Both | 37 | Phase 4 | United States |
| 39 | NCT01485003 (ClinicalTrials.gov) | February 7, 2012 | 1/12/2011 | Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants | A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients | Relapsing-Remitting Multiple Sclerosis | Biological: natalizumab | Biogen | NULL | Completed | 18 Years | 65 Years | All | 231 | United States | |
| 40 | EUCTR2010-021978-11-BE (EUCTR) | 03/02/2012 | 20/09/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Sweden | |||
| 41 | EUCTR2010-021978-11-IT (EUCTR) | 14/12/2011 | 02/03/2012 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis - 101MS326 | Multiple Sclerosis MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI*IV 1FL 300MG 15ML INN or Proposed INN: NA Other descriptive name: NA | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 856 | United States;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden | |||
| 42 | EUCTR2010-021978-11-PL (EUCTR) | 07/12/2011 | 28/10/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | |||
| 43 | EUCTR2010-021978-11-CZ (EUCTR) | 02/12/2011 | 22/08/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension | Secondary Progressive Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | Phase 3 | Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden;Ireland;Spain;Finland;United States | ||
| 44 | NCT01943526 (ClinicalTrials.gov) | November 30, 2011 | 12/9/2013 | Ireland Natalizumab (TYSABRI) Observational Program | Ireland Natalizumab (TYSABRI®) Observational Program (iTOP) | Relapsing-Remitting Multiple Sclerosis | Biological: natalizumab | Biogen | NULL | Completed | N/A | N/A | All | 191 | Ireland | |
| 45 | EUCTR2010-021978-11-ES (EUCTR) | 21/11/2011 | 26/09/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | Phase 3 | United States;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 46 | EUCTR2010-024000-10-IT (EUCTR) | 26/10/2011 | 27/12/2011 | A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis | A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI*IV 1FL 300MG 15ML Trade Name: TYSABRI*IV 1FL 300MG 15ML | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Spain;Belgium;Germany;Italy | ||
| 47 | EUCTR2010-021978-11-FI (EUCTR) | 28/09/2011 | 15/08/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension | Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | |||
| 48 | EUCTR2010-021978-11-DK (EUCTR) | 19/09/2011 | 23/08/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | Phase 3 | United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 49 | EUCTR2010-021978-11-DE (EUCTR) | 19/08/2011 | 04/04/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, with Optional Open-LabelExtension | Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | United States;Finland;Spain;Ireland;Russian Federation;Israel;United Kingdom;Iraq;Italy;France;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | |||
| 50 | EUCTR2010-024000-10-ES (EUCTR) | 08/08/2011 | 26/05/2011 | A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple Sclerosis | A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE | Relapsing-Remitting Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI Product Name: Natalizumab for IV Infusion Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB Product Name: Natalizumab for Subcutaneous Injection Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Belgium;Spain;Germany;Italy | ||
| 51 | EUCTR2010-021978-11-GB (EUCTR) | 26/07/2011 | 04/04/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension | Secondary Progressive Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 52 | EUCTR2010-024000-10-DE (EUCTR) | 19/07/2011 | 21/04/2011 | A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple Sclerosis | A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI Product Name: Natalizumab for IV Infusion Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB Product Name: Natalizumab for Subcutaneous Injection Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Spain;Belgium;Germany;Italy | ||
| 53 | EUCTR2010-024000-10-BE (EUCTR) | 28/06/2011 | 08/04/2011 | A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple Sclerosis | A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI Product Name: Natalizumab for IV Infusion Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB Product Name: Natalizumab for Subcutaneous Injection Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Spain;Belgium;Germany;Italy | ||
| 54 | EUCTR2010-021978-11-SE (EUCTR) | 04/05/2011 | 30/03/2011 | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282 | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 856 | United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | |||
| 55 | EUCTR2010-023560-40-SE (EUCTR) | 23/03/2011 | 21/12/2010 | Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed. | Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST | Relapsing-remitting multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Sendoxan Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE Trade Name: Thymoglobuline Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN Trade Name: Neupogen Trade Name: Solu-Medrol | Uppsala l?ns landsting | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | United States;Canada;Brazil;Sweden | |||
| 56 | NCT01455220 (ClinicalTrials.gov) | January 2011 | 10/10/2011 | The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis | The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis | Multiple Sclerosis | Drug: Tysabri ® (Natalizumab) | University of South Florida | NULL | Completed | 18 Years | 60 Years | All | 45 | N/A | United States |
| 57 | EUCTR2009-015556-15-AT (EUCTR) | 19/11/2010 | 07/06/2010 | A 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 | A 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: 12.0;Level: LLT;Classification code 10063399;Term: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 58 | NCT01440101 (ClinicalTrials.gov) | November 2010 | 14/4/2011 | Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) | Multicenter Study of BG00002 in Japanese Subjects With RRMS, Consisting of a Multiple-Dose, Open-Label Evaluation of Its Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Part A) and a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Evaluation of Safety and Efficacy (Part B) | Multiple Sclerosis | Drug: Natalizumab (BG00002);Drug: Placebo | Biogen | NULL | Completed | 18 Years | 65 Years | All | 106 | Phase 2/Phase 3 | Japan;China |
| 59 | EUCTR2009-015556-15-GB (EUCTR) | 02/09/2010 | 17/03/2010 | A 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 | A 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: 12.0;Level: LLT;Classification code 10063399;Term: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 60 | EUCTR2009-015556-15-DK (EUCTR) | 25/08/2010 | 17/06/2010 | A 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 | A 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: 12.0;Level: LLT;Classification code 10063399;Term: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden | |||
| 61 | EUCTR2009-015556-15-DE (EUCTR) | 20/08/2010 | 19/03/2010 | A 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 | A 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: 12.0;Level: LLT;Classification code 10063399;Term: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 62 | EUCTR2009-015556-15-NL (EUCTR) | 13/08/2010 | 08/04/2010 | A 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 | A 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: 12.0;Level: LLT;Classification code 10063399;Term: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 63 | EUCTR2009-009503-19-BE (EUCTR) | 20/07/2010 | 12/05/2009 | A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMER | A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMER | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Tysabri INN or Proposed INN: Natalizumab | Biogen Idec International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Belgium | ||
| 64 | EUCTR2009-015556-15-HU (EUCTR) | 14/07/2010 | 07/04/2010 | A 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 | A 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: 12.0;Level: LLT;Classification code 10063399;Term: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Hungary;Portugal;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 65 | EUCTR2009-015556-15-GR (EUCTR) | 13/07/2010 | 14/12/2010 | A 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 | A 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: 12.0;Level: LLT;Classification code 10063399;Term: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 66 | EUCTR2009-015556-15-PT (EUCTR) | 02/07/2010 | 30/03/2010 | A 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 | A 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: 12.0;Level: LLT;Classification code 10063399;Term: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden | |||
| 67 | EUCTR2009-015556-15-LV (EUCTR) | 11/06/2010 | 13/04/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A 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: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 76 | United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;Germany;Netherlands;Sweden | |||
| 68 | EUCTR2009-015556-15-CZ (EUCTR) | 10/06/2010 | 29/03/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A 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: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 76 | United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Germany;Netherlands;Latvia;Sweden | |||
| 69 | EUCTR2009-015556-15-SI (EUCTR) | 07/06/2010 | 12/04/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A 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: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 76 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Canada;Denmark;Slovenia;Spain;Greece;United States | |||
| 70 | EUCTR2009-015556-15-IT (EUCTR) | 07/06/2010 | 07/06/2010 | A 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 | A 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: 9.1;Level: LLT;Classification 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 LTD | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 71 | EUCTR2009-015556-15-ES (EUCTR) | 24/05/2010 | 24/03/2010 | Estudio 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 | Estudio 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: 12.0;Level: LLT;Classification code 10063399;Term: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 72 | EUCTR2009-015556-15-FI (EUCTR) | 07/05/2010 | 24/02/2010 | A 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 | A 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: 12.0;Level: LLT;Classification code 10063399;Term: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece | |||
| 73 | EUCTR2009-015556-15-SE (EUCTR) | 06/05/2010 | 09/03/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A 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: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 76 | United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Canada;Denmark;Germany;Netherlands;Sweden | |||
| 74 | EUCTR2009-017490-38-DE (EUCTR) | 03/05/2010 | 01/02/2010 | Randomized Treatment Interruption of Natalizumab - RESTORE | Randomized 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: 12.1;Level: LLT;Classification code 10063399;Term: 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 Idec | NULL | Not Recruiting | Female: yes Male: yes | 200 | Germany;Spain | |||
| 75 | NCT01071512 (ClinicalTrials.gov) | April 2010 | 17/2/2010 | Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis | Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis | Multiple Sclerosis | Drug: Tysabri | University of Chicago | Biogen | Completed | 18 Years | 60 Years | All | 20 | N/A | United States |
| 76 | NCT01070836 (ClinicalTrials.gov) | March 2010 | 17/2/2010 | JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab | JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2 | Relapsing Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Completed | N/A | N/A | Both | 35895 | N/A | United States;Puerto Rico |
| 77 | NCT01058005 (ClinicalTrials.gov) | March 2010 | 26/1/2010 | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis | A 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 Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: BG00002 (natalizumab);Drug: interferon beta-1a;Drug: glatiramer acetate | Biogen | Elan Pharmaceuticals | Terminated | 18 Years | 60 Years | All | 84 | Phase 3 | United States;Australia;Canada;Czech Republic;Finland;France;Hungary;Italy;Latvia;Poland;Slovenia;Spain;Sweden |
| 78 | NCT01070823 (ClinicalTrials.gov) | March 2010 | 17/2/2010 | JC-Virus (JCV) Antibody Program | JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1 | Multiple Sclerosis | Drug: Tysabri® (natalizumab) | Biogen | United BioSource Corporation;Elan Pharmaceuticals;United BioSource Corporation;Elan Pharmaceuticals | Completed | N/A | N/A | Both | 1096 | N/A | United States |
| 79 | EUCTR2009-016703-35-DK (EUCTR) | 08/01/2010 | 27/11/2009 | Natalizumabbehandling af progressiv multipel sklerose - NAPMS | Natalizumabbehandling af progressiv multipel sklerose - NAPMS | Secondary progressive multiple sclerosis and primary progressive multiple sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis MedDRA version: 12.0;Classification code 10063401;Term: Primary progressive multiple sclerosis | Trade Name: Tysabri Product Name: Natalizumab INN or Proposed INN: NATALIZUMAB Other descriptive name: Tysabri | Dansk Multipel Sclerose Center | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Denmark | ||
| 80 | NCT00871780 (ClinicalTrials.gov) | August 2009 | 26/3/2009 | A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients | A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients TIMER Study | Relapsing Remitting Multiple Sclerosis (RRMS) | Drug: BG00002 (natalizumab) | Biogen | Elan Pharmaceuticals | Completed | 18 Years | 60 Years | All | 224 | Phase 4 | Belgium;Mexico;Poland;Romania;Saudi Arabia;Ukraine;Venezuela |
| 81 | NCT00884481 (ClinicalTrials.gov) | March 23, 2009 | 17/4/2009 | Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMS | A Multi-centre and Prospective Trial to Evaluate the Effects on Multiple Sclerosis Related Fatigue During Treatment With Tysabri in Patients With Relapsing Remitting Multiple Sclerosis Over the Course of 12 Months | Relapsing-Remitting Multiple Sclerosis;Fatigue | Other: Natalizumab | Biogen | NULL | Completed | 18 Years | 65 Years | All | 195 | Austria;Denmark;Norway;Sweden;United States | |
| 82 | EUCTR2008-008065-35-SE (EUCTR) | 13/03/2009 | 17/12/2008 | A multi-centre and prospective trial to evaluate the effects on mul-tiple sclerosis related fatigue during treatment with Tysabri® in patients with relapsing remitting multiple sclerosis over the course of 12 months - TYNERGY | Mutiple sclerosis related fatigue in subjects with relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10016256;Term: Fatigue | Trade Name: Tysabri | BiogenIdec A/S | NULL | Not Recruiting | Female: yes Male: yes | 200 | Sweden | ||||
| 83 | NCT00818038 (ClinicalTrials.gov) | March 2009 | 5/1/2009 | A Proof of Concept Study to Evaluate the Effectiveness of Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) Patient Bladder Function | Phase IV, Proof of Concept Study to Evaluate Tysabri Effectiveness in RRMS Patient Bladder Function | Relapsing-Remitting Multiple Sclerosis | Drug: BG0002 (natalizumab) | Biogen Idec | NULL | Completed | 18 Years | 85 Years | Both | 30 | Phase 4 | United States |
| 84 | EUCTR2008-005906-38-FR (EUCTR) | 09/02/2009 | 19/03/2009 | Détermination de biomarqueurs associés à la réponse au Natalizumab dans la Sclérose en plaques | Détermination de biomarqueurs associés à la réponse au Natalizumab dans la Sclérose en plaques | sclérose en plaques MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Tysabri Product Name: Tysabri | CHU de Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | France | |||
| 85 | NCT00744679 (ClinicalTrials.gov) | November 2008 | 29/8/2008 | A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State | An Assessment of the Steady-State Pharmacokinetic and Pharmacodynamic Profile of Tysabri 300 mg Following at Least 12 Monthly Infusions | Multiple Sclerosis | Drug: Natalizumab | Biogen Idec | Elan Pharmaceuticals | Completed | 18 Years | 55 Years | Both | 20 | Phase 4 | United States |
| 86 | NCT00771043 (ClinicalTrials.gov) | November 2008 | 7/10/2008 | A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a | Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a | Relapsing-Remitting Multiple Sclerosis | Drug: TYSABRI and AVONEX | Biogen Idec | NULL | Withdrawn | 18 Years | 55 Years | Both | 50 | Phase 4 | United States |
| 87 | EUCTR2007-007394-22-GB (EUCTR) | 22/05/2008 | 11/04/2008 | The role of white and grey matter and meningeal inflammation in multiple sclerosis (MS) and clinically isolated syndromes (CIS) as quantified using [(11)C](R)-PK11195 positron emission tomography (PET) scanning | The role of white and grey matter and meningeal inflammation in multiple sclerosis (MS) and clinically isolated syndromes (CIS) as quantified using [(11)C](R)-PK11195 positron emission tomography (PET) scanning | Multiple Sclerosis MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive | Trade Name: Tysabri Product Name: Tysabri | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 4 | United Kingdom | ||
| 88 | NCT00536120 (ClinicalTrials.gov) | January 2008 | 25/9/2007 | The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis | A Randomized, Open-Label Study to Assess the Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Biological: BG00002 (natalizumab);Biological: keyhole limpet hemocyanin (KLH);Biological: tetanus diphtheria toxoid vaccine (Td) | Biogen | NULL | Completed | 18 Years | 60 Years | All | 60 | Phase 4 | United States |
| 89 | NCT00937677 (ClinicalTrials.gov) | November 2007 | 9/7/2009 | Effect of Tysabri in Patients With Relapsing-Remitting Multiple Sclerosis: A Follow-up Magnetization Transfer Imaging (MTI) Study | Effect of Natalizumab (Tysabri®) on Remyelination in Patients With Relapsing-remitting Multiple Sclerosis. A Follow-up Voxel-wise Magnetization Transfer Imaging Study. | Multiple Sclerosis | Drug: Tysabri | University at Buffalo | Biogen Idec | Completed | 18 Years | 65 Years | Both | 85 | N/A | United States |
| 90 | NCT00493298 (ClinicalTrials.gov) | June 29, 2007 | 27/6/2007 | Tysabri Observational Program | TOP: Tysabri® Observational Program | Relapsing-Remitting Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Active, not recruiting | 18 Years | 65 Years | All | 6620 | Argentina;Australia;Belgium;Brazil;Canada;Czechia;Finland;France;Germany;Greece;Italy;Mexico;Netherlands;Norway;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Denmark;Switzerland | |
| 91 | EUCTR2005-004061-41-SE (EUCTR) | 29/06/2007 | 15/12/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 521 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | |||
| 92 | EUCTR2005-004061-41-HU (EUCTR) | 22/11/2006 | 20/12/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (MS) MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 458 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | |||
| 93 | EUCTR2005-004061-41-GR (EUCTR) | 31/10/2006 | 28/07/2006 | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (MS) MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Finland;Czech Republic;Germany;United Kingdom;Denmark;Spain;Ireland;Italy;Greece;Austria;Sweden | |||
| 94 | EUCTR2005-004061-41-BE (EUCTR) | 17/07/2006 | 29/11/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 521 | Phase 3 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | ||
| 95 | EUCTR2005-004061-41-DK (EUCTR) | 19/06/2006 | 09/01/2006 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 458 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;New Zealand;Sweden | |||
| 96 | EUCTR2005-004061-41-GB (EUCTR) | 01/06/2006 | 25/10/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI 300 mg concentrate for solution for infusion Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 458 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;New Zealand;Sweden | ||
| 97 | EUCTR2005-004061-41-DE (EUCTR) | 18/05/2006 | 14/12/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 521 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | |||
| 98 | NCT00297232 (ClinicalTrials.gov) | March 2006 | 27/2/2006 | Natalizumab (Tysabri) Re-Initiation of Dosing | An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, C-1803, or C-1808 and a Dosing Suspension Safety Evaluation | Relapsing-Remitting Multiple Sclerosis | Drug: Natalizumab | Biogen | NULL | Terminated | 18 Years | N/A | All | 1094 | Phase 3 | Australia;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;New Zealand;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Austria |
| 99 | EUCTR2005-004061-41-IT (EUCTR) | 24/02/2006 | 21/04/2006 | Extension study with Natalizumab for pts already pertecipated in studies C-1801 e 1802 to evaluate safety of treatment | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | sclerosi multipla MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri INN or Proposed INN: Natalizumab | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 700 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Australia;Germany;New Zealand;Sweden | |||
| 100 | EUCTR2005-004061-41-FI (EUCTR) | 10/02/2006 | 01/12/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 458 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | |||
| 101 | EUCTR2005-004061-41-CZ (EUCTR) | 26/01/2006 | 11/01/2006 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (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] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 458 | Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | |||
| 102 | EUCTR2005-004061-41-IE (EUCTR) | 20/01/2006 | 08/12/2005 | TYSABRI Long Term Re-Dosing Study | An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA | Multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TYSABRI® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 458 | Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden |