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Novartis Pharmaceuticals
Traitements, essais et publications liés.
Traitements64programmes
Essais34liés
Publications48liées
SourceDBlocale
Traitements
64| Molécule | Indication / population | Phase | Objectif | Pays | Résultat |
|---|---|---|---|---|---|
| A Study Comparing Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world PracticeThis study aims to generate real-world evidence on the clinical effectiveness and economic burden of ofatumumab (OMB) versus ocrelizumab (OCR) in patients diagnosed with multiple sclerosis (MS) in the United States (US). Clinical effectiveness will be assessed using annualized relapse rate (ARR), while economic burden will be assessed using healthcare resource utilization (HCRU) and healthcare costs (HCC). This study will use two primary data sources that capture longitudinal, de-identified healthcare utilization derived from claims submitted for reimbursement. | SEP | À vérifier | À vérifier | United States | À vérifier |
| A Study of Treatment Patterns and Annualized Relapse Rate in Multiple Sclerosis Patients Who Escalate Versus Continue Disease-Modifying Therapies Following RelapseThe aim of this study was to describe real-world treatment patterns after relapsing on platform disease-modifying therapies (DMTs) in terms of proportions of patients who remain on platform DMTs or escalate to high-efficacy DMTs, as well as time to switching DMTs after relapse. Clinical effectiveness was characterized by comparing treatment failure rates in patients who escalate to high-efficacy DMTs versus those who remain on platform DMTs following initial relapse. | SEP | À vérifier | À vérifier | United States | À vérifier |
| A Survey to Evaluate Early Experience From Patient and Care Partner on Injection and Device for KESIMPTA® Indicated for Multiple SclerosisThis was a US-based, observational cross-sectional study with primary data collection via questionnaires directly administered to patients with MS receiving KESIMPTA and care partners of patients with MS (formal or informal)receiving KESIMPTA. | SEP | À vérifier | À vérifier | United States | À vérifier |
| AIOLOS — A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple SclerosisThis is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany. Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to four years. Additionally, medical history of participants will be collected including disease duration, laboratory values, EDSS, MRI parameters and relapses. | SEP | À vérifier | Germany | À vérifier | |
| AnsastrozoleThe purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC). | Cancer | Phase 3 | À vérifier | United States, Argentina, Australia, Brazil, Canada, China, Germany, Hong Kong, … | À vérifier |
| Antiepileptic drug (1 to 3 only)This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures. The study consisted of 4 phases for each patient Baseline phase:\[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)\], Core phase \[from randomization at Week 0 (V2) to Week 18 (V11)\], Extension phase \[from Week 18 (V11) until 48 weeks after the last patient had completed the core phase\] and Post Extension phase \[from end of Extension phase to end of study\]. | Épilepsie | Phase 3 | À vérifier | United States, Argentina, Australia, Belgium, Canada, Colombia, Denmark, France, … | À vérifier |
| CAD106This study will evaluate the safety and tolerability and Aß-specific antibody response of CAD106 in patients with mild to moderate Alzheimer's Disease. Patients also had a 2 year follow-up to assess disease progression where no drug was administered. | Alzheimer | Phase 1 | Ralentissement de la progression | Sweden | À vérifier |
| EAFToS — Characterizing the Use of Ofatumumab in a Real World SettingThis is a non-interventional primary use of data study utilizing de-identified patient-level onboarding and adherence data managed through the MSGo patient support service platform and includes a sub-study to explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes. | SEP | À vérifier | À vérifier | Australia | À vérifier |
| Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With HypertensionThis study was a non-interventional, secondary use of data, retrospective, cohort study, and the data to be extracted in this study was used as secondary use of collected patient information in the database (Japan Medical Data Survey \[JAMDAS\]) owned by M3 Inc. JAMDAS is a database that aggregates medical information and is constructed mainly from electronic medical record information of general practices, allowing real-time extraction of information entered in medical records, such as prescription status including drug switching and continuation, laboratory values, clinical evaluation scores, and comorbidities, etc. | Hypertension | À vérifier | À vérifier | United States | À vérifier |
| ExemestaneThis phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk. | Cancer | Phase 3 | À vérifier | United States, Argentina, Australia, Brazil, Canada, China, Germany, Hong Kong, … | À vérifier |
| Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the GulfThis is a retrospective and prospective, observational mixed-methods (quantitative and qualitative) cohort study of patients who are treated with either Ofatumumab or Ocrelizumab that will be recruited and followed up for one year to collect their profiles across the Gulf countries. | SEP | À vérifier | À vérifier | United Arab Emirates | À vérifier |
| GoserelinThe purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC). | Cancer | Phase 3 | À vérifier | United States, Argentina, Australia, Brazil, Canada, China, Germany, Hong Kong, … | À vérifier |
| IanalumabThe purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302). | Lupus | Phase 3 | À vérifier | United States, Brazil, China, Colombia, Czechia, France, Guatemala, Hong Kong, … | À vérifier |
| IptacopanThe study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate efficacy, safety and tolerability of iptacopan in patients with AChR+ gMG who are on stable SOC treatment. Participants who meet the eligibility criteria will be randomized in a ratio of 1:1, to receive either iptacopan or matching placebo, for 6 months (180 days) while continuing on a stable SOC treatment. The randomization will be stratified based on region. | Myasthénie | Phase 3 | À vérifier | United States, Argentina, Australia, Brazil, China, Denmark, France, Germany, … | À vérifier |
| Iptacopan (part 1)The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment. | Lupus | Phase 2 | À vérifier | United States, Argentina, Brazil, China, Colombia, France, Germany, Hong Kong, … | À vérifier |
| Iptacopan (part 2)The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment. | Lupus | Phase 2 | À vérifier | United States, Argentina, Brazil, China, Colombia, France, Germany, Hong Kong, … | À vérifier |
| LetrozoleThis study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC). | Cancer | Phase 3 | À vérifier | United States, Argentina, Australia, Brazil, Canada, China, Germany, Hong Kong, … | À vérifier |
| LeuprolideThe purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC). | Cancer | Phase 3 | À vérifier | United States, Argentina, Australia, Brazil, Canada, China, Germany, Hong Kong, … | À vérifier |
| Nilotinib followed by treatment-freeThe main purpose of the study was to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment | Cancer | Phase 2 | À vérifier | United States, Argentina, Austria, Belgium, Bulgaria, Colombia, Denmark, France, … | À vérifier |
| OfatumumabThis is an observational cross-sectional study of Ocrelizumab or Ofatumumab administrations for Relapsing forms of Multiple Sclerosis (RMS) in selected sites in the US, the UK and Australia. | SEP | À vérifier | Remyélinisation | United States, Australia | À vérifier |
| Ofatumumab approved doseThis study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis. | SEP | Phase 3 | À vérifier | United States, Puerto Rico | À vérifier |
| Ofatumumab new doseThis study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis. | SEP | Phase 3 | À vérifier | United States, Puerto Rico | À vérifier |
| OfatunumabThis study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum. | SEP | Phase 4 | À vérifier | United States, Germany, Italy, Poland, United Kingdom | À vérifier |
| open label RAD001 (only used for post-extension phase)This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures. The study consisted of 4 phases for each patient Baseline phase:\[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)\], Core phase \[from randomization at Week 0 (V2) to Week 18 (V11)\], Extension phase \[from Week 18 (V11) until 48 weeks after the last patient had completed the core phase\] and Post Extension phase \[from end of Extension phase to end of study\]. | Épilepsie | Phase 3 | À vérifier | United States, Argentina, Australia, Belgium, Canada, Colombia, Denmark, France, … | À vérifier |
| RAD001This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures. The study consisted of 4 phases for each patient Baseline phase:\[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)\], Core phase \[from randomization at Week 0 (V2) to Week 18 (V11)\], Extension phase \[from Week 18 (V11) until 48 weeks after the last patient had completed the core phase\] and Post Extension phase \[from end of Extension phase to end of study\]. | Épilepsie | Phase 3 | À vérifier | United States, Argentina, Australia, Belgium, Canada, Colombia, Denmark, France, … | À vérifier |
| rapcabtagene autoleucelThe purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN). | Lupus | Phase 2 | À vérifier | United States, Argentina, Australia, Austria, Brazil, Czechia, Denmark, France, … | À vérifier |
| rapcabtagene autoleucel (YTB323)This is an open-label, multi-center, non-confirmatory study to assess the safety, efficacy, and cellular kinetics of YTB323 in approximately 28 participants with Relapsing Multiple Sclerosis (RMS) with breakthrough disease activity during previous treatment with a highly efficacious therapy (BD-HET). The study design utilizes an ascending single dose design consisting of 3 sentinel cohorts followed by an expansion cohort. | SEP | Phase 1/2 | À vérifier | Australia, France, Germany, Italy, Spain, Switzerland | À vérifier |
| Remibrutinib (Blinded)A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment. | Myasthénie, SEP | Phase 3 | À vérifier | United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, … | À vérifier |
| Remibrutinib (Open Label)A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment. | Myasthénie, SEP | Phase 3 | À vérifier | United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, … | À vérifier |
| Remibrutinib oral treatmentThe purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS). | SEP | Phase 3 | À vérifier | United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, … | À vérifier |
| RibociclibThis study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC). | Cancer | Phase 3 | À vérifier | United States, Argentina, Australia, Brazil, Canada, China, Germany, Hong Kong, … | À vérifier |
| Risk Perception in Multiple SclerosisThis study was a retrospective, non-interventional, cross-sectional, multi-cohort study of patients clinically diagnosed with RMS (RRMS and SPMS). Patients were classified according to the immediate previous treatment in two groups, those who were prescribed with high efficacy treatments (HETs) and those who were prescribed with non-high efficacy treatments (non-HETs). HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod; and non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide. | SEP | À vérifier | À vérifier | United States | À vérifier |
| VHB937Description non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. | Sclérose latérale amyotrophique | Phase 2 | Traitement symptomatique | United States, Australia, Belgium, Canada, China, Denmark, France, Germany, … | À vérifier |
| YTB323This is a phase I/II study to assess safety, efficacy, and cellular kinetics of YTB323 in participants with treatment-resistant generalized myasthenia gravis. YTB323 is a Biological CAR-T cell therapy. | Lupus, Myasthénie | Phase 1/2 | Thérapie cellulaire | United States, France, Japan, United Kingdom | À vérifier |
| RAD001This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures. The study consisted of 4 phases for each patient Baseline phase:\[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)\], Core phase \[from randomization at Week 0 (V2) to Week 18 (V11)\], Extension phase \[from Week 18 (V11) until 48 weeks after the last patient had completed the core phase\] and Post Extension phase \[from end of Extension phase to end of study\]. | Épilepsie | Phase 3 | À vérifier | United States, Argentina, Australia, Belgium, Canada, Colombia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Poland, Russia, South Korea, … | À vérifier |
| IanalumabThe purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302). | Lupus | Phase 3 | À vérifier | United States, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, France, Germany, Guatemala, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, … | À vérifier |
| Risk Perception in Multiple SclerosisThis study was a retrospective, non-interventional, cross-sectional, multi-cohort study of patients clinically diagnosed with RMS (RRMS and SPMS). Patients were classified according to the immediate previous treatment in two groups, those who were prescribed with high efficacy treatments (HETs) and those who were prescribed with non-high efficacy treatments (non-HETs). HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod; and non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide. | SEP | À vérifier | À vérifier | United States | À vérifier |
| A Survey to Evaluate Early Experience From Patient and Care Partner on Injection and Device for KESIMPTA® Indicated for Multiple SclerosisThis was a US-based, observational cross-sectional study with primary data collection via questionnaires directly administered to patients with MS receiving KESIMPTA and care partners of patients with MS (formal or informal)receiving KESIMPTA. | SEP | À vérifier | À vérifier | United States | À vérifier |
| EAFToS — Characterizing the Use of Ofatumumab in a Real World SettingThis is a non-interventional primary use of data study utilizing de-identified patient-level onboarding and adherence data managed through the MSGo patient support service platform and includes a sub-study to explore the impact of ofatumumab on relevant patient reported outcomes (PROs) with respect to clinical outcomes. | SEP | À vérifier | À vérifier | Australia | À vérifier |
| CAD106This study will evaluate the safety and tolerability and Aß-specific antibody response of CAD106 in patients with mild to moderate Alzheimer's Disease. Patients also had a 2 year follow-up to assess disease progression where no drug was administered. | Alzheimer | Phase 1 | Ralentissement de la progression | Sweden | À vérifier |
| OfatunumabThis study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum. | SEP | Phase 4 | À vérifier | United States, Germany, Italy, Poland, United Kingdom | À vérifier |
| Remibrutinib oral treatmentThe purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS). | SEP | Phase 3 | À vérifier | United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Italy, Mexico, Portugal, Slovakia, South Africa, Spain, Switzerland, United Kingdom | À vérifier |
| Ofatumumab approved doseThis study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of a new dosage of ofatumumab compared to the approved dosage of ofatumumab followed by extended treatment in participants with relapsing multiple sclerosis. | SEP | Phase 3 | À vérifier | United States, Puerto Rico | À vérifier |
| Nilotinib followed by treatment-freeThe main purpose of the study was to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment | Cancer | Phase 2 | À vérifier | United States, Argentina, Austria, Belgium, Bulgaria, Colombia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Netherlands, Poland, Spain, Sweden, United Kingdom | À vérifier |
| IptacopanThe study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate efficacy, safety and tolerability of iptacopan in patients with AChR+ gMG who are on stable SOC treatment. Participants who meet the eligibility criteria will be randomized in a ratio of 1:1, to receive either iptacopan or matching placebo, for 6 months (180 days) while continuing on a stable SOC treatment. The randomization will be stratified based on region. | Myasthénie | Phase 3 | À vérifier | United States, Argentina, Australia, Brazil, China, Denmark, France, Germany, Greece, Israel, Italy, Japan, Poland, Portugal, Serbia, South Korea, Spain, United Kingdom | À vérifier |
| Remibrutinib (Blinded)A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment. | Myasthénie | Phase 3 | À vérifier | United States, Argentina, Australia, Belgium, Brazil, Canada, China, France, Georgia, Germany, India, Italy, Japan, Poland, Romania, Serbia, South Korea, Spain, Taiwan, United Kingdom | À vérifier |
| YTB323This is a phase I/II study to assess safety, efficacy, and cellular kinetics of YTB323 in participants with treatment-resistant generalized myasthenia gravis. YTB323 is a Biological CAR-T cell therapy. | Myasthénie | Phase 1/2 | Thérapie cellulaire | United States, France, Japan, United Kingdom | À vérifier |
| rapcabtagene autoleucel (YTB323)This is an open-label, multi-center, non-confirmatory study to assess the safety, efficacy, and cellular kinetics of YTB323 in approximately 28 participants with Relapsing Multiple Sclerosis (RMS) with breakthrough disease activity during previous treatment with a highly efficacious therapy (BD-HET). The study design utilizes an ascending single dose design consisting of 3 sentinel cohorts followed by an expansion cohort. | SEP | Phase 1/2 | À vérifier | Australia, France, Germany, Italy, Spain, Switzerland | À vérifier |
| Iptacopan (part 1)The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment. | Lupus | Phase 2 | À vérifier | United States, Argentina, Brazil, China, Colombia, France, Germany, Hong Kong, Hungary, India, Israel, Malaysia, Mexico, Philippines, Portugal, Puerto Rico, Singapore, Spain, Turkey (Türkiye), United Kingdom | À vérifier |
| IanalumabThe purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302). | Lupus | Phase 3 | À vérifier | United States, Argentina, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Guatemala, Hungary, Israel, Japan, Poland, Portugal, Slovakia, South Africa, Spain, Thailand, Turkey (Türkiye) | À vérifier |
| IanalumabThe purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302). | Lupus | Phase 3 | À vérifier | United States, Argentina, Australia, Chile, Colombia, France, Germany, India, Italy, Malaysia, Mexico, Romania, South Korea, Taiwan, United Kingdom | À vérifier |
| VHB937Description non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. | Sclérose latérale amyotrophique | Phase 2 | Traitement symptomatique | United States, Australia, Belgium, Canada, China, Denmark, France, Germany, Ireland, Italy, Netherlands, Poland, South Korea, Spain, Sweden, Switzerland, United Kingdom | À vérifier |
| Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the GulfThis is a retrospective and prospective, observational mixed-methods (quantitative and qualitative) cohort study of patients who are treated with either Ofatumumab or Ocrelizumab that will be recruited and followed up for one year to collect their profiles across the Gulf countries. | SEP | À vérifier | À vérifier | United Arab Emirates | À vérifier |
| OfatumumabThis is an observational cross-sectional study of Ocrelizumab or Ofatumumab administrations for Relapsing forms of Multiple Sclerosis (RMS) in selected sites in the US, the UK and Australia. | SEP | À vérifier | Remyélinisation | United States | À vérifier |
| Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With HypertensionThis study was a non-interventional, secondary use of data, retrospective, cohort study, and the data to be extracted in this study was used as secondary use of collected patient information in the database (Japan Medical Data Survey \[JAMDAS\]) owned by M3 Inc. JAMDAS is a database that aggregates medical information and is constructed mainly from electronic medical record information of general practices, allowing real-time extraction of information entered in medical records, such as prescription status including drug switching and continuation, laboratory values, clinical evaluation scores, and comorbidities, etc. | Hypertension | À vérifier | À vérifier | United States | À vérifier |
| A Study of Treatment Patterns and Annualized Relapse Rate in Multiple Sclerosis Patients Who Escalate Versus Continue Disease-Modifying Therapies Following RelapseThe aim of this study was to describe real-world treatment patterns after relapsing on platform disease-modifying therapies (DMTs) in terms of proportions of patients who remain on platform DMTs or escalate to high-efficacy DMTs, as well as time to switching DMTs after relapse. Clinical effectiveness was characterized by comparing treatment failure rates in patients who escalate to high-efficacy DMTs versus those who remain on platform DMTs following initial relapse. | SEP | À vérifier | À vérifier | United States | À vérifier |
| AIOLOS — A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple SclerosisThis is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany. Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to four years. Additionally, medical history of participants will be collected including disease duration, laboratory values, EDSS, MRI parameters and relapses. | SEP | À vérifier | Germany | À vérifier | |
| Remibrutinib (Blinded)A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment. | SEP | Phase 3 | À vérifier | United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, … | À vérifier |
| YTB323This is a phase I/II study to assess safety, efficacy, and cellular kinetics of YTB323 in participants with treatment-resistant generalized myasthenia gravis. YTB323 is a Biological CAR-T cell therapy. | Lupus | Phase 1/2 | Thérapie cellulaire | Australia, France, Germany, Spain, Switzerland | À vérifier |
| IanalumabThe purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302). | Lupus | Phase 3 | À vérifier | United States, Brazil, China, Colombia, Czechia, France, Guatemala, Hong Kong, Hungary, Malaysia, Mexico, Romania, Singapore, South Korea, Spain, Taiwan, Thailand, Vietnam | À vérifier |
| rapcabtagene autoleucelThe purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN). | Lupus | Phase 2 | À vérifier | United States, Argentina, Australia, Austria, Brazil, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Romania, Saudi Arabia, Singapore, … | À vérifier |
| rapcabtagene autoleucel (YTB323)This is an open-label, multi-center, non-confirmatory study to assess the safety, efficacy, and cellular kinetics of YTB323 in approximately 28 participants with Relapsing Multiple Sclerosis (RMS) with breakthrough disease activity during previous treatment with a highly efficacious therapy (BD-HET). The study design utilizes an ascending single dose design consisting of 3 sentinel cohorts followed by an expansion cohort. | SEP | Phase 1/2 | Ralentissement de la progression | Australia, Canada, France, Germany, Italy, Spain, Switzerland | À vérifier |
| A Study Comparing Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world PracticeThis study aims to generate real-world evidence on the clinical effectiveness and economic burden of ofatumumab (OMB) versus ocrelizumab (OCR) in patients diagnosed with multiple sclerosis (MS) in the United States (US). Clinical effectiveness will be assessed using annualized relapse rate (ARR), while economic burden will be assessed using healthcare resource utilization (HCRU) and healthcare costs (HCC). This study will use two primary data sources that capture longitudinal, de-identified healthcare utilization derived from claims submitted for reimbursement. | SEP | À vérifier | À vérifier | United States | À vérifier |
| RibociclibThis study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC). | Cancer | Phase 3 | À vérifier | United States, Argentina, Australia, Brazil, Canada, China, Germany, Hong Kong, India, Israel, Mexico, Portugal, Puerto Rico, South Korea, Taiwan, Turkey (Türkiye) | À vérifier |
Essais cliniques
34| Molécule | Indication / population | Phase | NCT | Titre | Statut |
|---|---|---|---|---|---|
| Ribociclib | Cancer | Phase 3 | NCT05827081 | Adjuvant WIDER — Phase IIIb Study of Ribociclib + ET in Early Breast Cancer | RECRUITING |
| A Study Comparing Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice | SEP | À vérifier | NCT07779460 | A Study Comparing Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice | RECRUITING |
| rapcabtagene autoleucel (YTB323) | SEP | Phase 1/2 | NCT06675864 | Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease Progression and Cellular Kinetics Following YTB323 Administration in Participants With Non-active Progressive Multiple Sclerosis (PMS) | ACTIVE_NOT_RECRUITING |
| rapcabtagene autoleucel | Lupus | Phase 2 | NCT06581198 | A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN) | ACTIVE_NOT_RECRUITING |
| Ianalumab | Lupus | Phase 3 | NCT06711887 | Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension) | RECRUITING |
| YTB323 | Lupus | Phase 1/2 | NCT05798117 | An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus | ACTIVE_NOT_RECRUITING |
| Remibrutinib (Blinded) | SEP | Phase 3 | NCT07225504 | REMASTER — A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis | RECRUITING |
| AIOLOS — A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis | SEP | À vérifier | NCT05344469 | AIOLOS — A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis | RECRUITING |
| A Study of Treatment Patterns and Annualized Relapse Rate in Multiple Sclerosis Patients Who Escalate Versus Continue Disease-Modifying Therapies Following Relapse | SEP | À vérifier | NCT07743281 | A Study of Treatment Patterns and Annualized Relapse Rate in Multiple Sclerosis Patients Who Escalate Versus Continue Disease-Modifying Therapies Following Relapse | COMPLETED |
| Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension | Hypertension | À vérifier | NCT06604897 | Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension | COMPLETED |
| Ofatumumab | SEP | À vérifier | NCT05171972 | Reduced Oligodendrocyte-specific Cytotoxicity and Ofatumumab Treatment | COMPLETED |
| Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf | SEP | À vérifier | NCT05266469 | Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf | COMPLETED |
| VHB937 | Sclérose latérale amyotrophique | Phase 2 | NCT06643481 | ASTRALS — A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS) | ACTIVE_NOT_RECRUITING |
| Ianalumab | Lupus | Phase 3 | NCT05624749 | Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2) | ACTIVE_NOT_RECRUITING |
| Ianalumab | Lupus | Phase 3 | NCT05639114 | Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) | ACTIVE_NOT_RECRUITING |
| Iptacopan (part 1) | Lupus | Phase 2 | NCT05268289 | Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V | RECRUITING |
| Erenumab | Migraine | Phase 4 | NCT04084314 | APOLLON — Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study | COMPLETED |
| rapcabtagene autoleucel (YTB323) | SEP | Phase 1/2 | NCT06617793 | An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis | ACTIVE_NOT_RECRUITING |
| YTB323 | Myasthénie | Phase 1/2 | NCT06704269 | Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis | ACTIVE_NOT_RECRUITING |
| Remibrutinib (Blinded) | Myasthénie | Phase 3 | NCT06744920 | RELIEVE — A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis | RECRUITING |
| Iptacopan | Myasthénie | Phase 3 | NCT06517758 | A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG. | ACTIVE_NOT_RECRUITING |
| Nilotinib followed by treatment-free | Cancer | Phase 2 | NCT01784068 | ENESTfreedom — Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients | COMPLETED |
| Ofatumumab approved dose | SEP | Phase 3 | NCT06869785 | FILIOS — Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a New Maintenance Dosing Regimen of Ofatumumab | ACTIVE_NOT_RECRUITING |
| Remibrutinib oral treatment | SEP | Phase 3 | NCT06846281 | Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis. | RECRUITING |
| Interferon beta-1a | SEP | Phase 3 | NCT01892722 | Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis | ACTIVE_NOT_RECRUITING |
| Ofatunumab | SEP | Phase 4 | NCT06444113 | KATHAROS — Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis | ACTIVE_NOT_RECRUITING |
| CAD106 | Alzheimer | Phase 1 | NCT00411580 | Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (AD) | COMPLETED |
| EAFToS — Characterizing the Use of Ofatumumab in a Real World Setting | SEP | À vérifier | NCT05090033 | EAFToS — Characterizing the Use of Ofatumumab in a Real World Setting | COMPLETED |
| A Survey to Evaluate Early Experience From Patient and Care Partner on Injection and Device for KESIMPTA® Indicated for Multiple Sclerosis | SEP | À vérifier | NCT05334472 | A Survey to Evaluate Early Experience From Patient and Care Partner on Injection and Device for KESIMPTA® Indicated for Multiple Sclerosis | COMPLETED |
| Ocrelizumab | SEP | À vérifier | NCT04676555 | TIMIOS — Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis | COMPLETED |
| Risk Perception in Multiple Sclerosis | SEP | À vérifier | NCT05528666 | Risk Perception in Multiple Sclerosis | COMPLETED |
| Ianalumab | Lupus | Phase 3 | NCT06133972 | Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension). | RECRUITING |
| RAD001 | Épilepsie | Phase 3 | NCT01713946 | A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures | COMPLETED |
| Fingolimod | SEP | À vérifier | NCT01285479 | The Gilenya Pregnancy Registry | COMPLETED |
Publications
48| Molécule | Indication / population | Titre | Journal | Date |
|---|---|---|---|---|
| rapcabtagene autoleucel | Very unusual extremely high ferritin with cytokine release syndrome in a patient with hematological malignancy after experimental chimeric antigen receptor (CAR)-T-Cell therapy. | Clinica chimica acta; international journal of clinical chemistry | ||
| Antiepileptic drug (1 to 3 only) | Cannabidiolic acid (CBDA) and CBDA-rich extracts modulatory effects on voltage-dependent NaV1.2 sodium channels. | Phytomedicine : international journal of phytotherapy and phytopharmacology | ||
| Antiepileptic drug (1 to 3 only) | Reporting quality and evidence support in randomized controlled trials of Bupleurum-based herbal medicine formulas for epilepsy. | Journal of ethnopharmacology | ||
| Antiepileptic drug (1 to 3 only) | Development and pharmacokinetic evaluation of a phospholipid complex self-nanoemulsifying drug delivery system (PLC-SNEDDS) for enhanced oral bioavailability of cannabidiol. | Drug delivery | ||
| RAD001 | CXCR4, CXCR7 and PBRM1 are responsible for everolimus and cabozantinib resistance in human renal cancer cells. | Cell death discovery | ||
| VHB937 | petBrain: a new pipeline for amyloid, Tau tangles and neurodegeneration quantification using PET and MRI. | Alzheimer's research & therapy | ||
| VHB937 | Simulated shared and supported decision making for amyloid immunotherapy in Alzheimer's disease: A bicentric study. | Revue neurologique | ||
| VHB937 | Defining Alzheimer's disease: stipulations and the ethics of diagnostic change. | Journal of neurology, neurosurgery, and psychiatry | ||
| Iptacopan (part 2) | Results of a randomized double-blind placebo-controlled Phase 2 study propose iptacopan as an alternative complement pathway inhibitor for IgA nephropathy. | Kidney international | ||
| Iptacopan (part 1) | A Retrospective Claims Analysis of the Rate of Complications in Patients Undergoing Treatment for Paroxysmal Nocturnal Hemoglobinuria. | Advances in therapy | ||
| Nilotinib followed by treatment-free | Unraveling clinical and biological predictors of successful treatment free remission in Chronic Myeloid Leukemia and its impact on the healthcare system in a low- and middle-income country. | Pakistan journal of medical sciences | ||
| Nilotinib followed by treatment-free | Treatment-Free Remission and Immune Profiling after Frontline Second-Generation TKI Therapy in CML. | Blood advances | ||
| Nilotinib followed by treatment-free | Low-dose dasatinib in second-line therapy or beyond for the treatment of chronic-phase chronic myeloid leukemia: a real-world cohort study. | Frontiers in pharmacology | ||
| Exemestane | A phase II study of androgen receptor inhibition by darolutamide in combination with leuprolide acetate and exemestane in recurrent adult-type ovarian granulosa cell tumor. | Gynecologic oncology | ||
| Exemestane | Exemestane induces neurodevelopmental defects and behavioral diorder in zebrafish embryos by p53 signaling pathway. | Comparative biochemistry and physiology. Toxicology & pharmacology : CBP | ||
| Exemestane | AKR1C3 and CLIC3 mediate the comorbidity of diabetic foot ulcers and hypercholesterolemia via the TGF-β/lipid metabolism axis. | Biochemical and biophysical research communications | ||
| Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension | Acute myocardial infarction in a patient with HAM/TSP evaluated for circulatory dynamics during mobilization before and after antihypertensive drug modification: a case report. | Journal of medical case reports | ||
| Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension | Randomized-controlled trial of sacubitril/valsartan and amlodipine combination in Japanese uncontrolled hypertensive patients (J-SAMIT). | Hypertension research : official journal of the Japanese Society of Hypertension | ||
| Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension | Prescription patterns of sacubitril/valsartan among patients with hypertension in Japan. | Frontiers in cardiovascular medicine | ||
| Ofatumumab new dose | Severe autoimmune hepatitis and necrotising pancreatitis following ofatumumab in a patient with multiple sclerosis. | BMJ case reports | ||
| Ofatumumab approved dose | Ofatumumab Treatment Used in Pediatric MOGAD: A Retrospective Case Series. | Journal of central nervous system disease | ||
| Ofatumumab | Immunoglobulin dynamics and infection risk with ofatumumab versus ocrelizumab in multiple sclerosis. | Multiple sclerosis and related disorders | ||
| Risk Perception in Multiple Sclerosis | Narrative analysis and clinical meta-synthesis of YouTube storytelling by men living with multiple sclerosis. | Journal of health psychology | ||
| Iptacopan (part 2) | Inhibition of alternative complement system and prolyl hydroxylase ameliorates anaemia of inflammation. | Inflammopharmacology | ||
| Iptacopan (part 2) | Targeting the Roots of Kidney Disease: Systematic Review of the Therapies Targeting the Complement System. | Medicina (Kaunas, Lithuania) | ||
| Iptacopan (part 1) | The Complement System: An Important New Therapeutic Target in IgA Nephropathy. | Glomerular diseases | ||
| Iptacopan (part 1) | New and Emerging Nonimmunosuppressive Drug Therapies for Primary Adult Glomerular Diseases. | Kidney medicine | ||
| Ofatumumab new dose | Case Report of Combined Central and Peripheral Demyelination: Treated With Ofatumumab. | Immunity, inflammation and disease | ||
| Ofatumumab approved dose | Translating B-Cell and Plasma-Cell Targeting from Oncology to Autoimmunity: Modalities, Quantitative Bridging, and a Development Roadmap. | Clinical pharmacology and therapeutics | ||
| Ofatumumab approved dose | Anti-CD20 Therapies in Pediatric Acquired Demyelinating Syndromes: Evidence Across MS, AQP4-IgG-Positive NMOSD and MOGAD. | CNS drugs | ||
| Remibrutinib oral treatment | Remibrutinib impact on disease control, sleep, and quality of life: Analysis of phase 3 REMIX-1/2. | Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology | ||
| Remibrutinib oral treatment | Emerging synthetic drugs for the management of hidradenitis suppurativa: a comprehensive update. | Expert opinion on pharmacotherapy | ||
| Ofatumumab | Eculizumab treatment in the salvage therapy of MOGAD: a case report. | Frontiers in immunology | ||
| Antiepileptic drug (1 to 3 only) | Pharmaceutical cocktails in aquatic ecosystems: unveiling the hidden ecotoxicological threats to Microcystis aeruginosa. | Environmental geochemistry and health | ||
| Antiepileptic drug (1 to 3 only) | Parvalbumin interneuron activation rescues both seizures and impaired social novelty in digenic absence epilepsy mice. | Science advances | ||
| CAD106 | Effects of the active amyloid beta immunotherapy CAD106 on PET measurements of amyloid plaque deposition in cognitively unimpaired APOE ε4 homozygotes. | Alzheimer's & dementia : the journal of the Alzheimer's Association | ||
| CAD106 | Immunotherapeutic approaches for Alzheimer's disease: Exploring active and passive vaccine progress. | Brain research | ||
| Ofatumumab | Lymphoplasmapheresis for Refractory Anti-N-Methyl-D-Aspartate Receptor Encephalitis: A Case Report. | Journal of clinical apheresis | ||
| Ofatumumab | Possible Contribution of Multiple Sclerosis Pathology to Treatment-Resistant Schizophrenia: A Case Study. | Neuropsychopharmacology reports | ||
| Risk Perception in Multiple Sclerosis | Efficacy and safety of ocrelizumab in primary progressive multiple sclerosis, including older patients and those with more advanced disease (ORATORIO-HAND): a multicentre, double-blind, randomised, placebo-controlled, phase 3b study. | Lancet (London, England) | ||
| Risk Perception in Multiple Sclerosis | Pressure Ulcer Prevention at Home for People with Long-term Neurological Conditions, Carers and Personal Assistants: Synopsis - a Participatory, Qualitative study (PUP@Home1). | Health and social care delivery research | ||
| Ianalumab | From Molecular Pathophysiology to Clinical Trial Design in Sjögren's Disease: A Three-Axis Framework. | International journal of molecular sciences | ||
| Antiepileptic drug (1 to 3 only) | Rapid Eye Movement Sleep Suppressing Antidepressant Prescription is Associated with Improved Survival in Amyotrophic Lateral Sclerosis. | Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology | ||
| Ianalumab | Ianalumab plus Eltrombopag in Immune Thrombocytopenia. | The New England journal of medicine | ||
| Ianalumab | Ianalumab plus Eltrombopag in Immune Thrombocytopenia. Reply. | The New England journal of medicine | ||
| Antiepileptic drug (1 to 3 only) | TPPU protects against seizures and seizure-associated comorbidities by inhibiting the Akt/mTOR signaling pathway in KA-induced convulsant mice. | Frontiers in immunology | ||
| Antiepileptic drug (1 to 3 only) | Long-Term Inhaled Cannabis Therapy for Chronic Low Back Pain: A Five-Year Retrospective Analysis of Prospectively Collected Patient-Reported Outcomes in 241 Treatment-Refractory Patients. | Biomedicines | ||
| RAD001 | Retraction notice to "Effects of the combination of RAD001 and docetaxel on breast cancer stem cells" [Eur J Cancer 48 (2012) 1581-1592]. | European journal of cancer (Oxford, England : 1990) |