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 | NCT05265728 (ClinicalTrials.gov) | March 25, 2022 | 23/2/2022 | A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis | A Single-Arm, Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered to Japanese Participants With Relapsing-Remitting Multiple Sclerosis Via a Subcutaneous Route of Administration | Multiple Sclerosis, Relapsing-Remitting | Drug: Natalizumab | Biogen | NULL | Not yet recruiting | 18 Years | 65 Years | All | 20 | Phase 3 | NULL |
| 2 | JPRN-jRCT2051210146 | 24/02/2022 | 26/12/2021 | Phase 3 Study to Evaluate Efficacy, Safety, PK, and PD of SC Natalizumab in Japanese Participants With RRMS | A Single-Arm, Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered to Japanese Participants With Relapsing-Remitting Multiple Sclerosis via a Subcutaneous Route of Administration | Relapsing-Remitting Multiple Sclerosis | Participants will receive natalizumab 300 mg SC Q4W for 48 weeks. | Amir Hadi Maghzi | NULL | Pending | >= 18age old | <= 65age old | Both | 20 | Phase 3 | Japan |
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | NCT03689972 (ClinicalTrials.gov) | December 26, 2018 | 27/9/2018 | A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab 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 | Multiple Sclerosis, Relapsing-Remitting | Drug: Natalizumab | Biogen | NULL | Active, not recruiting | 18 Years | 60 Years | All | 500 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;United Kingdom |
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | EUCTR2014-000917-30-DE (EUCTR) | 25/11/2014 | 03/07/2014 | Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis | A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis | Multiple Sclerosis (MS) 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] | Product Name: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 113 | Phase 2 | Belgium;Denmark;Germany;Italy | ||
| 15 | 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 | ||
| 16 | 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 | |||
| 17 | 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 | ||
| 18 | EUCTR2014-000917-30-BE (EUCTR) | 21/10/2014 | 24/07/2014 | Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis | A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis | Multiple Sclerosis (MS) 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] | Product Name: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 113 | Belgium;Denmark;Italy | |||
| 19 | EUCTR2014-000917-30-DK (EUCTR) | 02/09/2014 | 10/07/2014 | Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis | A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis | Multiple Sclerosis (MS) 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] | Product Name: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 113 | Belgium;Denmark;Italy | |||
| 20 | EUCTR2014-000917-30-IT (EUCTR) | 25/07/2014 | 07/07/2014 | Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple Sclerosis | A Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis | Multiple Sclerosis (MS) 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] | Product Name: Natalizumab for Subcutaneous Injection INN or Proposed INN: NATALIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 113 | Belgium;Denmark;Italy | |||
| 21 | 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 |
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 |
| 25 | 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 | |||
| 26 | 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 | |||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | |||
| 30 | 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 | ||
| 31 | 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 | |||
| 32 | 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 | ||
| 33 | 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 | ||
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | 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 | |||
| 37 | 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 |
| 38 | NCT01416155 (ClinicalTrials.gov) | October 2010 | 24/3/2011 | Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis | A Long-Term, Open-Label, Multicenter, Extension Study to Evaluate Safety and Efficacy of BG00002 in Japanese Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Completed | 18 Years | 65 Years | All | 97 | Phase 2 | Japan;China |
| 39 | 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 |
| 40 | 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 |
| 41 | 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 | |
| 42 | 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 |
| 43 | EUCTR2005-004061-41-AT (EUCTR) | 06/07/2007 | 15/12/2005 | 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) | 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 | 900 | Finland;Czech Republic;Germany;United Kingdom;Denmark;Spain;Ireland;Italy;Greece;Austria;Sweden | |||
| 44 | 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 | |||
| 45 | 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 | |||
| 46 | 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 | |||
| 47 | NCT00516893 (ClinicalTrials.gov) | October 2006 | 14/8/2007 | Natalizumab High Titer Immunogenicity and Safety | A Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Biological: BG00002-E (natalizumab high titer) | Biogen | Elan Pharmaceuticals | Completed | 18 Years | 55 Years | All | 113 | Phase 2 | United States |
| 48 | 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 | ||
| 49 | 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 | |||
| 50 | 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 | ||
| 51 | 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 | |||
| 52 | NCT00306592 (ClinicalTrials.gov) | March 2006 | 31/1/2006 | Natalizumab 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, or C-1803 and a Dosing Suspension Safety Evaluation | Multiple Sclerosis, Relapsing-Remitting | Biological: BG00002 (natalizumab) | Biogen | Elan Pharmaceuticals | Completed | 18 Years | N/A | All | 404 | Phase 3 | United States;Canada |
| 53 | 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 | |||
| 54 | 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 | |||
| 55 | 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 |