Gilenya® ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 13 |
13. 多発性硬化症／視神経脊髄炎
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 | NCT02373098 (ClinicalTrials.gov) | March 31, 2015 | 4/2/2015 | Fingolimod Effect on Cytokine and Chemokine Levels | Effects of Fingolimod (Gilenya®) on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod 0.5 mg | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 126 | Phase 4 | Turkey |
| 2 | 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 | ||
| 3 | NCT02241785 (ClinicalTrials.gov) | September 30, 2014 | 12/9/2014 | Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies | A Phase 4 Multicenter, Open-Label, Single Arm Study to Evaluate Switching From BRACET/Gilenya® to Natalizumab in Subjects With Relapsing Forms of Multiple Sclerosis (MS) | Relapsing Multiple Sclerosis | Drug: natalizumab | Biogen | NULL | Terminated | 18 Years | 60 Years | All | 47 | Phase 4 | United States;Germany |
| 4 | 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 | ||||
| 5 | NCT02325440 (ClinicalTrials.gov) | March 2014 | 4/9/2014 | Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya | A 32-week, Monocentric, Exploratory, Single Arm Study to Assess Immune Function and MRI Disease Activity in Patients With RRMS Transferred From Previous Treatment With Natalizumab to Gilenya® (Fingolimod) | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Natalizumab | University Hospital Muenster | Novartis | Recruiting | 18 Years | 65 Years | Both | 15 | Phase 4 | Germany |
| 6 | NCT01647880 (ClinicalTrials.gov) | July 2013 | 23/7/2012 | MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study) | Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic Neuritis | Multiple Sclerosis | Drug: Verum arm receiving Gilenya®;Drug: Active Comparator receiving Extavia® | Charite University, Berlin, Germany | NeuroCure Clinical Research Center, Charite, Berlin | Terminated | 18 Years | 55 Years | All | 15 | Phase 2/Phase 3 | Germany |
| 7 | NCT03216915 (ClinicalTrials.gov) | June 1, 2013 | 22/6/2017 | Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis | FINGORHYMS - Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Gilenya®; Novartis Pharmaceuticals Corporation | Universitätsklinikum Hamburg-Eppendorf | NULL | Recruiting | 18 Years | N/A | All | 100 | Germany | |
| 8 | EUCTR2012-000411-91-DE (EUCTR) | 13/02/2013 | 04/12/2012 | Monitoring natural killer cells in multiple sclerosis patients treated with fingolimod | Monitoring natural killer cells in multiple sclerosis patients treated with fingolimod: a monocentric, prospective, one year, baseline-to-treatment, open-label, single group pilot trial - NKZellen-Version1.0 | relapsing-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya® Product Name: Gilenya® Product Code: Gilenya® INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | Charité - Universitätsmedizin Berlin | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | Germany | ||
| 9 | EUCTR2011-004787-30-DE (EUCTR) | 26/10/2012 | 13/07/2012 | Modification of the visual outcome after optic neuritis in CIS or MS by Gilenya® | Modification of the visual outcome after optic neuritis in CIS or MS by Gilenya® - MOVING | Multiple sclerosis or clinically isolated syndrom;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya® Product Name: Gilenya® Product Code: Gilenya® INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD Trade Name: Extavia® Product Name: Extavia® Product Code: Extavia® INN or Proposed INN: Interferon beta 1B Other descriptive name: INTERFERON BETA-1B | Charite Universitaetsmedizin Berlin | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 3 | Germany | ||
| 10 | NCT01705236 (ClinicalTrials.gov) | August 20, 2012 | 13/8/2012 | A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya® | A 3-year Multi-center Study to Describe the Long Term Changes of Optical Coherence Tomography (OCT) Parameters in Patients Under Treatment With Gilenya® | Relapsing Remitting Multiple Sclerosis RRMS | Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 87 | Phase 4 | Germany;Switzerland |
| 11 | EUCTR2012-000674-31-DE (EUCTR) | 01/08/2012 | 27/04/2012 | A 3-year, multi-center study to describe the long term changes of optical coherence tomography (OCT) parameters in patients under treatment with Gilenya® | A 3-year, multi-center study to describe the long term changes of optical coherence tomography (OCT) parameters in patients under treatment with Gilenya® | RNFLT in Patients with relapsing remitting Multiple Sclerosis 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: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: Fingolimod Hydrochloride | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Germany;Switzerland | ||
| 12 | EUCTR2011-002969-38-DE (EUCTR) | 08/11/2011 | 30/09/2011 | A 6-month, multicenter, randomized, controlled parallel group study to evaluate the effect of physical training on fatigue in patients with relapsing-remitting multiple sclerosis treated with fingolimod (Gilenya®), followed by a 6 month optional extension phase | A 6-month, multicenter, randomized, controlled parallel group study to evaluate the effect of physical training on fatigue in patients with relapsing-remitting multiple sclerosis treated with fingolimod (Gilenya®), followed by a 6 month optional extension phase - | Fatigue in Patients with relapsing remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: Fingolimod Hydrochloride | Novartis Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 13 | EUCTR2011-001280-49-FR (EUCTR) | 14/06/2011 | 14/04/2011 | « GRACE : Gilenya® - Réponse Au Coping - Evaluation » Etude clinique menée dans plusieurs centres français, d'une durée de 4 mois, visant à comparer la réponse à l'initiation du traitement par fingolimod (Gilenya®) selon le profil d'anxiété chez des patients adultes présentant une sclérose en plaques rémittente-récurrente très active. | « GRACE : Gilenya® - Réponse Au Coping - Evaluation » Etude multicentrique de phase IV, prospective, en ouvert, d'une durée de 4 mois, visant à comparer la réponse à l’initiation du fingolimod (Gilenya®) selon le profil de « coping » chez des patients adultes présentant une sclérose en plaques rémittente-récurrente très active en France. - GRACE | Sclérose en plaques rémittente-récurrente active 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: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma S.A.S | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | France |