PARACETAMOL ( DrugBank: Paracetamol )
6 diseases
告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
3 | 脊髄性筋萎縮症 | 2 |
6 | パーキンソン病 | 1 |
13 | 多発性硬化症/視神経脊髄炎 | 5 |
35 | 天疱瘡 | 1 |
46 | 悪性関節リウマチ | 8 |
49 | 全身性エリテマトーデス | 2 |
3. 脊髄性筋萎縮症
臨床試験数 : 237 / 薬物数 : 123 - (DrugBank : 29) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 75
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 | NCT03648658 (ClinicalTrials.gov) | February 18, 2019 | 8/8/2018 | Paracetamol Study in Patients With Low Muscle Mass | Pharmacokinetics and Safety of Treatment With Paracetamol in Children and Adults With Spinal Muscular Atrophy and Cerebral Palsy | SMA II;Cerebral Palsy | Drug: Paracetamol 120Mg/5mL Oral Suspension | Mette Cathrine Oerngreen | Elsass Foundation | Recruiting | 6 Years | 45 Years | All | 48 | Phase 4 | Denmark |
2 | EUCTR2018-002295-40-DK (EUCTR) | 11/09/2018 | 11/07/2018 | Is treatment with the painkiller paracetamol safe in patients with spinal muscular atrophy and cerebral palsy? | Pharmacokinetics and safety of treatment with paracetamol in children and adults with spinal muscular atrophy and cerebral palsy - Paracetamol study in patients with low muscle mass | Spinal muscular atrophy type II (SMA II)Cerebral palsy (CP);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | INN or Proposed INN: Paracetamol Other descriptive name: PARACETAMOL | Copenhagen Neuromuscular Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1;Phase 4 | Denmark |
6. パーキンソン病
臨床試験数 : 2,307 / 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
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 | NCT02305017 (ClinicalTrials.gov) | March 2014 | 28/11/2014 | Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers | Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers | Parkinson's Disease | Drug: BIA 9-1067;Drug: Paracetamol | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 28 | Phase 1 | NULL |
13. 多発性硬化症/視神経脊髄炎
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
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 | NCT04688788 (ClinicalTrials.gov) | April 28, 2021 | 22/12/2020 | Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis | Danish Non-inferiority Study of Ocrelizumab and Rituximab in MS (DanNORMS): A Randomized Study Comparing the Efficacy of Ocrelizumab and Rituximab in Active Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple Sclerosis | Drug: Rituximab;Drug: Ocrelizumab;Drug: Fexofenadine;Drug: Paracetamol;Drug: Methylprednisolone | Rigshospitalet, Denmark | Odense University Hospital;Aarhus University Hospital;Aalborg University Hospital;Herlev Hospital;Hillerod Hospital, Denmark;Zealand University Hospital;Kolding Sygehus;Regional Hospital Holstebro;Hvidovre University Hospital;Hospital of South West Jutland, Esbjerg, Denmark;GCP unit, Copenhagen University Hospital;GCP-unit at Aarhus University Hospital, Aarhus, Denmark;Hospital of Southern Jutland, Sønderborg, Denmark;Hospital of Central Denmark Region, Viborg, Denmark;Danske Regioner | Recruiting | 18 Years | 65 Years | All | 594 | Phase 3 | Denmark |
2 | EUCTR2017-004702-17-IT (EUCTR) | 07/11/2018 | 04/11/2020 | A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients. | A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients - ND | Multiple sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: FORMISTIN - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE Product Name: Formistin 10 mg Product Code: [Formistin 10 mg] Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE Product Name: Tachipirina Product Code: [Tachipirina CPR 500mg] Other descriptive name: paracetamolo 500 mg Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML Product Name: Solumedrol IM 125mg/2ml Product Code: [Metilprednisolone] Other descriptive name: Metilprednisolone sodio succinato Trade Name: Arzerra Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Other descriptive name: Ofatumumab Trade Name: Arzerra Product Name: ofatumumab Product Code: [OMB157] INN or Proposed INN: Ofatumumab Other descriptive name: OFATUMUMAB | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 284 | Phase 2 | United States;Czechia;Estonia;Spain;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Poland;Bulgaria;Germany;Latvia | ||
3 | NCT03368664 (ClinicalTrials.gov) | October 24, 2017 | 2/11/2017 | A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT | A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT) | Multiple Sclerosis | Drug: Alemtuzumab GZ402673;Drug: Glatiramer acetate;Drug: Beta-Interferon;Drug: Methylprednisolone;Drug: Ranitidine;Drug: Ceterizine;Drug: Dexchlorpheniramine;Drug: Paracetamol;Drug: Acyclovir;Drug: Prednisolone;Drug: Diphenydramine;Drug: Other H1 antagonist | Genzyme, a Sanofi Company | NULL | Active, not recruiting | 10 Years | 17 Years | All | 50 | Phase 3 | Austria;Belgium;France;Italy;Netherlands;Poland;Portugal;Russian Federation;Turkey;United Kingdom;Bulgaria;Czechia;Germany;Greece;Norway;Spain;Switzerland |
4 | NCT02583594 (ClinicalTrials.gov) | December 6, 2015 | 16/10/2015 | A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis | A Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple Sclerosis | Progressive Multiple Sclerosis | Drug: Acyclovir;Drug: Methylprednisolone;Drug: alemtuzumab GZ402673;Drug: Paracetamol;Drug: Loratadine;Drug: Ceterizine;Drug: Dexchlorpheniramine | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | N/A | All | 24 | Phase 1 | Spain |
5 | NCT02205489 (ClinicalTrials.gov) | October 2014 | 29/7/2014 | Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA | Single Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADA | Relapsing-remitting Multiple Sclerosis | Drug: Alemtuzumab GZ402673;Drug: cetirizine;Drug: ranitidine;Drug: methylprednisolone;Drug: aciclovir;Drug: esomeprazole;Drug: ibuprofen;Drug: paracetamol | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | N/A | Both | 58 | Phase 4 | Belgium;France;Netherlands;Spain |
35. 天疱瘡
臨床試験数 : 99 / 薬物数 : 124 - (DrugBank : 36) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 169
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 | NCT02613910 (ClinicalTrials.gov) | December 23, 2015 | 23/11/2015 | Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris | OPV117059: A Long-Term Extension Study of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris | Pemphigus | Drug: Ofatumumab;Drug: Acetaminophen/paracetamol;Drug: Antihistamine (cetirizine or equivalent);Drug: Prednisone/Prednisolone | GlaxoSmithKline | NULL | Terminated | N/A | N/A | All | 1 | Phase 3 | United States |
46. 悪性関節リウマチ
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
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 | EUCTR2015-003333-95-LT (EUCTR) | 21/07/2016 | 09/05/2016 | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE) | A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR) | Stroke (ischaemic stroke or intracerebral hemorrhage) MedDRA version: 22.1;Level: PT;Classification code 10061256;Term: Ischaemic stroke;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: LLT;Classification code 10022754;Term: Intracerebral hemorrhage;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 22.1;Classification code 10042244;Term: Stroke;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Paracetamol Product Name: Paracetamol INN or Proposed INN: Paracetamol Other descriptive name: PARACETAMOL Trade Name: Ceftriaxone Product Name: Ceftriaxone INN or Proposed INN: CEFTRIAXONE Trade Name: Metoclopramide Product Name: Metoclopramide INN or Proposed INN: METOCLOPRAMIDE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Greece;Netherlands;Hungary;Norway;Poland;Italy;United Kingdom;Germany;Estonia | ||
2 | EUCTR2011-002633-19-DE (EUCTR) | 21/12/2011 | 02/08/2011 | Prednisolone test for patients with an inflammatory joint disease | Diagnostic value of oral prednisolone test for rheumatoid arthritis - RZR12011-TryCort | rheumatoid arthritis MedDRA version: 14.0;Level: LLT;Classification code 10062719;Term: Seronegative rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Product Name: Paracetamol INN or Proposed INN: PARACETAMOL | Rheumazentrum Ruhrgebiet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
3 | EUCTR2006-004062-13-IT (EUCTR) | 18/07/2006 | 30/08/2006 | Randomised, open label, no profit, clinical, multicenter study of phase II and IIIB to assess efficacy and tolerability of oxycodone/paracetamol compared to anti-inflammatory non-steroidal drugs FANS and corticosteroid, in patients suffering moderate to severe chronic pain due to rheumatoid arthritis. - Do.R.A. | Randomised, open label, no profit, clinical, multicenter study of phase II and IIIB to assess efficacy and tolerability of oxycodone/paracetamol compared to anti-inflammatory non-steroidal drugs FANS and corticosteroid, in patients suffering moderate to severe chronic pain due to rheumatoid arthritis. - Do.R.A. | RHEUMATOID ARTHRITIS MedDRA version: 6.1;Level: PT;Classification code 10039073 | Trade Name: DEPALGOS*20+325MG 28CPR RP INN or Proposed INN: OXICODONE DC.IT INN or Proposed INN: PARACETAMOLO DC.IT FU | A.U.S.L. RIMINI | NULL | Not Recruiting | Female: yes Male: yes | 149 | Phase 2 | Italy | ||
4 | EUCTR2004-000074-31-BE (EUCTR) | 15/03/2005 | 07/07/2004 | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis | rheumatoid arthritis MedDRA version: 7.0;Level: LLT;Classification code 10039073 | Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat INN or Proposed INN: not available Other descriptive name: L-000124467 Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat INN or Proposed INN: not available Other descriptive name: L-000124467 Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat INN or Proposed INN: not available Other descriptive name: L-000124467 Trade Name: paracetamol (acetaminophen) Product Name: paracetamol (acetaminophen) | Merck Sharp & Dohme BV | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Sweden | ||
5 | EUCTR2004-004302-24-CZ (EUCTR) | 09/03/2005 | 04/02/2005 | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 7.0;Level: LLT;Classification code 10039073 | Product Name: L-000883191 Product Code: L-000883191 INN or Proposed INN: NA Other descriptive name: NA Trade Name: PARALEN 500 Product Name: PARALEN 500 Product Code: 8594739041288 INN or Proposed INN: paracetamol Other descriptive name: NA | Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 2 | Czech Republic;Finland;Spain;Germany;Italy | ||
6 | EUCTR2004-004302-24-ES (EUCTR) | 16/02/2005 | 04/11/2005 | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 7.0;Level: LLT;Classification code 10039073 | Product Name: L-000883191 Product Code: L-000883191 INN or Proposed INN: NA Other descriptive name: NA Trade Name: Paracetamol Product Name: Paracetamol Product Code: NA INN or Proposed INN: NA Other descriptive name: NA | Merck & Co. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 2 | Czech Republic;Finland;Spain;Germany;Italy | ||
7 | EUCTR2004-004302-24-FI (EUCTR) | 18/01/2005 | 17/11/2004 | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 7.0;Level: LLT;Classification code 10039073 | Product Name: L-000883191 Product Code: L-000883191 INN or Proposed INN: NA Other descriptive name: NA Trade Name: Paracetamol Product Name: Paracetamol Product Code: NA INN or Proposed INN: NA Other descriptive name: NA | Suomen MSD Oy | NULL | Not Recruiting | Female: yes Male: yes | 136 | Finland;Czech Republic;Germany;Spain;Italy | |||
8 | EUCTR2004-000074-31-SE (EUCTR) | 06/07/2004 | 21/05/2004 | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis | A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis | rheumatoid arthritis MedDRA version: 7.0;Level: LLT;Classification code 10039073 | Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat INN or Proposed INN: not available Other descriptive name: L-000124467 Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat INN or Proposed INN: not available Other descriptive name: L-000124467 Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c Product Code: L-000124467 (freebase); L-000124467-009J (succinat INN or Proposed INN: not available Other descriptive name: L-000124467 Trade Name: paracetamol (acetaminophen) Product Name: paracetamol (acetaminophen) | Merck Sharp & Dohme (Sweden) AB | NULL | Not Recruiting | Female: yes Male: yes | 150 | Sweden |
49. 全身性エリテマトーデス
臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
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 | NCT04702256 (ClinicalTrials.gov) | December 9, 2021 | 30/11/2020 | Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF | Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF | Lupus Nephritis;Systemic Lupus Erythematosus (SLE) | Drug: Obinutuzumab administration;Drug: Administration of Methylprednisolone + Prednisone + Mycophenolate mofetil;Drug: Administration of methylprednisolone, paracetamol and dexchlorpheniramine | Assistance Publique - Hôpitaux de Paris | Roche Pharma AG | Recruiting | 14 Years | N/A | All | 196 | Phase 3 | France |
2 | NCT04963296 (ClinicalTrials.gov) | October 26, 2021 | 7/7/2021 | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Obinutuzumab;Drug: Placebo;Drug: Acetaminophen/Paracetamol;Drug: Diphenhydramine hydrochloride;Drug: Methylprednisolone | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 75 Years | All | 200 | Phase 3 | United States;Argentina;Brazil;France;Italy;Mexico;New Zealand;Peru;Poland;Russian Federation;South Africa;Spain;United Kingdom |