PREDNISONE ( DrugBank: Prednisone )
45 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 1 |
| 11 | 重症筋無力症 | 11 |
| 13 | 多発性硬化症／視神経脊髄炎 | 10 |
| 14 | 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー | 2 |
| 19 | ライソゾーム病 | 3 |
| 26 | HTLV-1関連脊髄症 | 3 |
| 35 | 天疱瘡 | 12 |
| 40 | 高安動脈炎 | 2 |
| 41 | 巨細胞性動脈炎 | 64 |
| 42 | 結節性多発動脈炎 | 2 |
| 43 | 顕微鏡的多発血管炎 | 28 |
| 44 | 多発血管炎性肉芽腫症 | 26 |
| 45 | 好酸球性多発血管炎性肉芽腫症 | 3 |
| 46 | 悪性関節リウマチ | 61 |
| 49 | 全身性エリテマトーデス | 27 |
| 50 | 皮膚筋炎／多発性筋炎 | 10 |
| 51 | 全身性強皮症 | 1 |
| 53 | シェーグレン症候群 | 4 |
| 61 | 自己免疫性溶血性貧血 | 3 |
| 63 | 特発性血小板減少性紫斑病 | 7 |
| 64 | 血栓性血小板減少性紫斑病 | 1 |
| 65 | 原発性免疫不全症候群 | 2 |
| 66 | IgA腎症 | 16 |
| 79 | 家族性高コレステロール血症（ホモ接合体） | 1 |
| 81 | 先天性副腎皮質酵素欠損症 | 2 |
| 84 | サルコイドーシス | 9 |
| 85 | 特発性間質性肺炎 | 6 |
| 86 | 肺動脈性肺高血圧症 | 1 |
| 95 | 自己免疫性肝炎 | 2 |
| 96 | クローン病 | 18 |
| 97 | 潰瘍性大腸炎 | 14 |
| 113 | 筋ジストロフィー | 16 |
| 162 | 類天疱瘡（後天性表皮水疱症を含む。） | 8 |
| 164 | 眼皮膚白皮症 | 1 |
| 205 | 脆弱Ｘ症候群関連疾患 | 1 |
| 222 | 一次性ネフローゼ症候群 | 25 |
| 224 | 紫斑病性腎炎 | 5 |
| 228 | 閉塞性細気管支炎 | 1 |
| 283 | 後天性赤芽球癆 | 1 |
| 284 | ダイアモンド・ブラックファン貧血 | 1 |
| 288 | 自己免疫性後天性凝固因子欠乏症 | 1 |
| 299 | 嚢胞性線維症 | 1 |
| 300 | IgG4関連疾患 | 6 |
| 307 | カナバン病 | 1 |
| 331 | 特発性多中心性キャッスルマン病 | 4 |
2. 筋萎縮性側索硬化症
臨床試験数 : 645 / 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
| 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 | NCT01884571 (ClinicalTrials.gov) | October 2013 | 19/6/2013 | Immunosuppression in Amyotrophic Lateral Sclerosis (ALS) | A Novel Immunosuppression Intervention for the Treatment of Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: Basiliximab;Drug: Methylprednisolone;Drug: Prednisone;Drug: Tacrolimus;Drug: Mycophenolate mofetil | Emory University | ALS Association | Completed | 18 Years | N/A | All | 31 | Phase 2 | United States |
11. 重症筋無力症
臨床試験数 : 332 / 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
| 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 | NCT04768465 (ClinicalTrials.gov) | January 1, 2021 | 21/2/2021 | Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis | Effectiveness and Safety of Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis: A Real-world Study | Myasthenia Gravis | Drug: Pyridostigmine, Prednisone, Tacrolimus;Drug: Pyridostigmine, Tacrolimus | Da, Yuwei, M.D. | NULL | Recruiting | 18 Years | N/A | All | 160 | China | |
| 2 | ChiCTR1800017564 | 2018-09-08 | 2018-08-04 | Optimal Timing of Thymectomy in Nonthymomatous Myasthenia Gravis Patients In China: A Follow-up Prospective Study | Optimal Timing of Thymectomy in Nonthymomatous Myasthenia Gravis Patients In China: A Prospective Study | Myasthenia Gravis | Experiment group versus Control group:Thymectomy plus oral prednisone, an immunosuppressant protocol versus Prednisone, or immunosuppressants alone; | The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine | NULL | Pending | 1 | 80 | Both | Experiment group versus Control group:822; | China | |
| 3 | ChiCTR-IPR-15006081 | 2014-07-18 | 2015-03-14 | A prospective study of combined use of prednisone and methotrexate for the treatment of myasthenia gravis | A prospective study of combined use of prednisone and methotrexate for the treatment of myasthenia gravis | myasthenia gravis | prednisone group:prednisone;Prednisone + methotrexate:Prednisone + methotrexate; | Xuan Wu Hospital, Capital Medical University | NULL | Recruiting | 18 | 80 | Both | prednisone group:15;Prednisone + methotrexate:15; | Phase 4 | NULL |
| 4 | NCT00995722 (ClinicalTrials.gov) | December 2011 | 14/10/2009 | Efficacy of Prednisone In the Treatment of Ocular Myasthenia | Efficacy of Prednisone In the Treatment of Ocular Myasthenia: The EPITOME' Study | Ocular Myasthenia Gravis | Drug: Prednisone;Drug: Placebo | Michael Benatar | University of Miami;University of Rochester | Terminated | 18 Years | N/A | All | 11 | Phase 3 | United States;Canada |
| 5 | NCT00987116 (ClinicalTrials.gov) | June 2009 | 29/9/2009 | Study Comparing Two Tapering Strategies of Prednisone in Myasthenia Gravis | Comparison of Two Tapering Strategies of Prednisone in Patients With Generalised Myasthenia Gravis Treated With Prednisone and Azathioprine: a Single-blind Randomised Controlled Multicenter Study | Myasthenia Gravis | Drug: Prednisone - Azathioprine | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | 80 Years | All | 118 | Phase 4 | France |
| 6 | NCT00716066 (ClinicalTrials.gov) | June 2008 | 15/7/2008 | Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune Diseases | High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases | Autoimmune Disease;Neurologic Autoimmune Disease;Autologous Transplant Autoimmune;Multiple Sclerosis Transplant;MS Stem Cell Transplant;Multiple Sclerosis Stem Cell Transplant;Stiff Person Syndrome;HCT for Neurologic Autoimmune Disorders;CIDP Transplant;Myasthenia Gravis Transplant;Autoimmune Nervous System Disorder;Central Nervous System Vasculitis;Cerebellar Degeneration;Chronic Inflammatory Demyelinating Polyneuropathy;Lambert Eaton Myasthenic Syndrome;Myasthenia Gravis;Neuromyelitis Optica;Opsoclonus Myoclonus Syndrome;Rasmussen Subacute Encephalitis | Biological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Carmustine;Drug: Cytarabine;Drug: Etoposide;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Prednisone;Procedure: Syngeneic Bone Marrow Transplantation | Fred Hutchinson Cancer Center | NULL | Recruiting | N/A | 71 Years | All | 80 | Phase 2 | United States |
| 7 | NCT00294658 (ClinicalTrials.gov) | June 2006 | 21/2/2006 | Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy | A Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving Prednisone | Myasthenia Gravis | Procedure: thymectomy plus prednisone;Drug: prednisone alone | University of Alabama at Birmingham | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 18 Years | 65 Years | All | 126 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;Chile;Germany;Italy;Japan;Mexico;Netherlands;Poland;Portugal;South Africa;Spain;Taiwan;Thailand;United Kingdom;Ireland |
| 8 | EUCTR2005-000343-28-IT (EUCTR) | 29/03/2006 | 15/03/2006 | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis - ND | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis - ND | Myasthenia Gravis MedDRA version: 6.1;Level: PT;Classification code 10028417 | Trade Name: cellcept INN or Proposed INN: Mycophenolic acid | ASPREVA PHARMACEUTICALS CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 136 | United Kingdom;Germany;Spain;Italy | |||
| 9 | EUCTR2005-000343-28-DE (EUCTR) | 19/12/2005 | 10/05/2005 | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) | Myasthenia Gravis MedDRA version: 8.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis | Trade Name: Cellcept 500 mg tablets Product Name: CellCept 500 mg tablets INN or Proposed INN: mycophenolate mofetil | Aspreva Pharmaceuticals Corporation | NULL | Not Recruiting | Female: yes Male: yes | 136 | Spain;Germany;Italy;United Kingdom | |||
| 10 | EUCTR2005-000343-28-GB (EUCTR) | 05/09/2005 | 28/06/2005 | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) | An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) | Myasthenia Gravis MedDRA version: 7;Level: PT;Classification code 10028417 | Product Name: CellCept 500 mg tablets INN or Proposed INN: mycophenolate mofetil | Aspreva Pharmaceutical Corporation | NULL | Not Recruiting | Female: yes Male: yes | 136 | Germany;United Kingdom;Spain;Italy | |||
| 11 | NCT00408213 (ClinicalTrials.gov) | June 2004 | 5/12/2006 | A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis. | A Randomized, Double-Blind Study to Evaluate the Safety of Continued Treatment With CellCept in Patients With Well-Controlled Myasthenia Gravis Receiving a Stable Dose of Prednisone | Myasthenia Gravis Generalised | Drug: mycophenolate mofetil [CellCept];Drug: Placebo | Hoffmann-La Roche | Aspreva Pharmaceuticals | Completed | 18 Years | 80 Years | Both | 136 | Phase 3 | United States;Former Serbia and Montenegro;France;Germany;Italy;Ukraine;United Kingdom;Israel;Spain;Canada;Czech Republic;Mexico;Netherlands |
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 | NCT03424733 (ClinicalTrials.gov) | September 25, 2017 | 31/1/2018 | Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side Effects | A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a | Multiple Sclerosis | Drug: Plegridy;Drug: Prednisone;Drug: Tylenol Pill | Holy Name Medical Center, Inc. | Biogen | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | United States |
| 2 | NCT02784210 (ClinicalTrials.gov) | October 5, 2016 | 26/5/2016 | Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques | The Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded Study | Multiple Sclerosis | Drug: Methylprednisolone;Drug: Prednisone | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 3 | NCT02809079 (ClinicalTrials.gov) | January 2016 | 12/6/2016 | Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients | Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients | Neuromyelitis Optica Spectrum Disorders;Mycophenolate Mofetil;Efficacy and Safety | Drug: Mycophenolate mofetil;Drug: Prednisone | Third Affiliated Hospital, Sun Yat-Sen University | Zhongshan Ophthalmic Centre, Sun Yat-sen University;Nangfang Hospital, Southern Medical University | Enrolling by invitation | 18 Years | 65 Years | Both | 100 | Phase 4 | NULL |
| 4 | NCT01411514 (ClinicalTrials.gov) | August 2011 | 26/5/2011 | Oral Prednisone Taper Versus Placebo for the Treatment of Acute Relapses in Multiple Sclerosis | Phase IV Study of Oral Prednisone Taper vs. Placebo Following Intravenous Steroids for the Treatment of Acute Relapses in Multiple Sclerosis Within the Ticino Cohort | Multiple Sclerosis | Drug: Prednisone;Drug: Placebo | Claudio Gobbi | Ente Ospedaliero Cantonale, Ticino, Switzerland | Terminated | 18 Years | 80 Years | Both | 27 | Phase 4 | Switzerland |
| 5 | NCT00716066 (ClinicalTrials.gov) | June 2008 | 15/7/2008 | Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune Diseases | High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases | Autoimmune Disease;Neurologic Autoimmune Disease;Autologous Transplant Autoimmune;Multiple Sclerosis Transplant;MS Stem Cell Transplant;Multiple Sclerosis Stem Cell Transplant;Stiff Person Syndrome;HCT for Neurologic Autoimmune Disorders;CIDP Transplant;Myasthenia Gravis Transplant;Autoimmune Nervous System Disorder;Central Nervous System Vasculitis;Cerebellar Degeneration;Chronic Inflammatory Demyelinating Polyneuropathy;Lambert Eaton Myasthenic Syndrome;Myasthenia Gravis;Neuromyelitis Optica;Opsoclonus Myoclonus Syndrome;Rasmussen Subacute Encephalitis | Biological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Carmustine;Drug: Cytarabine;Drug: Etoposide;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Prednisone;Procedure: Syngeneic Bone Marrow Transplantation | Fred Hutchinson Cancer Center | NULL | Recruiting | N/A | 71 Years | All | 80 | Phase 2 | United States |
| 6 | NCT00288626 (ClinicalTrials.gov) | July 2006 | 7/2/2006 | High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) Study | A Phase II Study of High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, Melphalan, Thymoglobulin and Autologous CD34+ Hematopoietic Stem Cell Transplant for the Treatment of Poor Prognosis Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: Granulocyte-colony stimulating factor (G-CSF) and prednisone;Drug: Carmustine, etoposide, cytarabine, and melphalan (BEAM);Procedure: Autologous hematopoietic stem cell transplant | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN) | Completed | 18 Years | 60 Years | All | 25 | Phase 2 | United States |
| 7 | NCT00203047 (ClinicalTrials.gov) | January 2005 | 13/9/2005 | Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer Acetate | A Multi-Centered, Randomized, Double-Blind, Placebo Controlled Study Assessing the Add-on Effect of Oral Steroids in Relapsing Remitting Multiple Sclerosis Subjects Treated With Glatiramer Acetate (GA) | Relapsing Remitting Multiple Sclerosis | Drug: Glatiramer Acetate;Drug: Placebo;Drug: Prednisone | Teva Pharmaceutical Industries | NULL | Terminated | 18 Years | 55 Years | All | 414 | Phase 4 | Canada;United States |
| 8 | NCT00014755 (ClinicalTrials.gov) | December 1997 | 10/4/2001 | Phase I Pilot Study of Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed By Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: filgrastim;Drug: prednisone;Procedure: peripheral blood stem cell transplantation;Procedure: irradiation | Fred Hutchinson Cancer Research Center | NULL | Completed | 18 Years | 60 Years | Both | 35 | Phase 1 | United States | |
| 9 | NCT00000146 (ClinicalTrials.gov) | July 1988 | 23/9/1999 | Optic Neuritis Treatment Trial (ONTT) | Multiple Sclerosis;Optic Neuritis | Drug: Methylprednisolone;Drug: Prednisone | National Eye Institute (NEI) | NULL | Active, not recruiting | 18 Years | 46 Years | Both | Phase 3 | United States | ||
| 10 | NCT00000147 (ClinicalTrials.gov) | July 1988 | 23/9/1999 | Longitudinal Optic Neuritis Study (LONS) | Multiple Sclerosis;Optic Neuritis | Drug: Methylprednisolone;Drug: Prednisone | National Eye Institute (NEI) | NULL | Active, not recruiting | 18 Years | 46 Years | Both | N/A | United States |
14. 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー
臨床試験数 : 175 / 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
| 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 | NCT00716066 (ClinicalTrials.gov) | June 2008 | 15/7/2008 | Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune Diseases | High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases | Autoimmune Disease;Neurologic Autoimmune Disease;Autologous Transplant Autoimmune;Multiple Sclerosis Transplant;MS Stem Cell Transplant;Multiple Sclerosis Stem Cell Transplant;Stiff Person Syndrome;HCT for Neurologic Autoimmune Disorders;CIDP Transplant;Myasthenia Gravis Transplant;Autoimmune Nervous System Disorder;Central Nervous System Vasculitis;Cerebellar Degeneration;Chronic Inflammatory Demyelinating Polyneuropathy;Lambert Eaton Myasthenic Syndrome;Myasthenia Gravis;Neuromyelitis Optica;Opsoclonus Myoclonus Syndrome;Rasmussen Subacute Encephalitis | Biological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Carmustine;Drug: Cytarabine;Drug: Etoposide;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Prednisone;Procedure: Syngeneic Bone Marrow Transplantation | Fred Hutchinson Cancer Center | NULL | Recruiting | N/A | 71 Years | All | 80 | Phase 2 | United States |
| 2 | NCT01349270 (ClinicalTrials.gov) | June 2004 | 5/5/2011 | Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg | Multicentre Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg in Patients With Chronic Inflammatory Demyelinating Polyneuropathy on a One Year Follow up | Demyelinating Polyneuropathy | Drug: Immunoglobulin perfusion;Drug: Prednisone | Centre Hospitalier Universitaire de Saint Etienne | Laboratoire français de Fractionnement et de Biotechnologies | Completed | 18 Years | 80 Years | Both | 40 | Phase 3 | France |
19. ライソゾーム病
臨床試験数 : 899 / 薬物数 : 684 - (DrugBank : 99) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 182
| 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 | NCT05487599 (ClinicalTrials.gov) | December 20, 2022 | 1/6/2022 | A Clinical Trial of PR001 (LY3884961) in Patients With Peripheral Manifestations of Gaucher Disease (PROCEED) | An Open-label, Dose-Finding, Phase 1/2 Study to Evaluate the Safety and Tolerability of a Single Intravenous Dose of LY3884961 in Patients With Peripheral Manifestations of Gaucher Disease (PROCEED) | Gaucher Disease | Biological: LY3884961;Drug: Methylprednisolone;Drug: Sirolimus;Drug: Prednisone | Prevail Therapeutics | Eli Lilly and Company | Recruiting | 18 Years | 50 Years | All | 15 | Phase 1/Phase 2 | United States |
| 2 | EUCTR2019-000667-24-IT (EUCTR) | 28/03/2022 | 23/09/2021 | A Phase I/II Study to Assess the Safety and Tolerability of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy, in Subjects with Fabry Disease | A Phase I/II, Multicenter, Open-Label, SingleDose, Dose-Ranging Study to Assess the Safety and Tolerability of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy in Subjects with Fabry Disease - STAAR | Fabry Disease (X-linked lysosomal storage disease) MedDRA version: 20.0;Level: PT;Classification code 10016016;Term: Fabry's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Recombinant Adeno-associated virus 2/6 vector encoding the cDNA for human alpha galactosidase A Product Code: [ST-920] Other descriptive name: Adeno-associated virus serotype 2/6 encoding human alpha-galactosidase A cDNA Trade Name: PARACETAMOLO DOC GENERICI - 1000 MG COMPRESSA 16 COMPRESSE Product Name: Paracetamolo Product Code: [Paracetamolo] INN or Proposed INN: PARACETAMOLO Trade Name: ALISERIN - 25 MG GRANULATO EFFERVESCENTE 20 BUSTINE Product Name: difenidramina cloridrato Product Code: [difenidramina cloridrato] INN or Proposed INN: DIFENIDRAMINA CLORIDRATO Trade Name: PREDNISONE DOC GENERICI - 5 MG COMPRESSE 10 COMPRESSE IN BLISTER PVC-PVDC/ALU Product Name: Prednisone Product Code: [Prednisone] INN or Proposed INN: PREDNISONE | Sangamo Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 1;Phase 2 | United States;Taiwan;Canada;Australia;Germany;United Kingdom;Italy | ||
| 3 | NCT03952637 (ClinicalTrials.gov) | August 19, 2019 | 15/5/2019 | A Phase 1/2 Study of Intravenous Gene Transfer With an AAV9 Vector Expressing Human Beta-galactosidase in Type I and Type II GM1 Gangliosidosis | A Phase 1/2 Study of Intravenous Gene Transfer With an AAV9 Vector Expressing Human Beta-galactosidase in Type I and Type II GM1 Gangliosidosis | Lysosomal Diseases;Gangliosidosis;GM1 | Biological: AAV9-GLB1;Procedure: Abdominal ultrasound;Drug: Rituximab;Drug: Sirolimus;Drug: Methylprednisolone;Drug: Prednisone;Diagnostic Test: Audiology assessment with ABR;Diagnostic Test: Bone density scan (DEXA);Diagnostic Test: Electrocardiogram (EKG);Diagnostic Test: Echocardiogram;Other: Electroencephalogram (EEG) awake and extended overnight;Diagnostic Test: Laboratory tests;Procedure: Lumbar puncture;Procedure: Brain MRI/MRS/fMRI;Behavioral: Neurocognitive testing;Other: Neurology exam;Behavioral: PICC or other Central line placement;Procedure: Skeletal survey;Procedure: Skin biopsy;Procedure: Speech and modified barium swallow study;Procedure: Ophthalmology exam | National Human Genome Research Institute (NHGRI) | Sio Gene Therapies | Active, not recruiting | 6 Months | 12 Years | All | 16 | Phase 1/Phase 2 | United States |
26. HTLV-1関連脊髄症
臨床試験数 : 29 / 薬物数 : 47 - (DrugBank : 29) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 119
| 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 | NCT04301076 (ClinicalTrials.gov) | June 15, 2020 | 6/3/2020 | Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment (EPOCH) for Adult T-Cell Leukemia-Lymphoma (ATL) | A Phase 1 Study of Lenalidomide in Combination With EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL) | Acute Adult T-Cell Leukemia/Lymphoma;Adult T-Cell Leukemia/Lymphoma;Chronic Adult T-Cell Leukemia/Lymphoma;HTLV-1 Infection | Drug: Cyclophosphamide;Drug: Doxorubicin Hydrochloride;Drug: Etoposide;Drug: Lenalidomide;Drug: Prednisone;Drug: Vincristine Sulfate | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 1 | United States |
| 2 | NCT01000285 (ClinicalTrials.gov) | September 2010 | 19/10/2009 | EPOCH Chemotherapy and Bortezomib for Associated T-Cell Leukemia Lymphoma | Phase I/II Trial of Dose-Adjusted EPOCH Chemotherapy With Bortezomib Combined With Integrase Inhibitor Therapy for HTLV-1 Associated T-Cell Leukemia Lymphoma | Leukemia-Lymphoma, Adult T-Cell | Drug: Bortezomib;Drug: Etoposide;Drug: Vincristine;Drug: Doxorubicin;Drug: Prednisone;Drug: Cyclophosphamide;Drug: Raltegravir | Washington University School of Medicine | NULL | Completed | 18 Years | N/A | All | 18 | Phase 1/Phase 2 | United States |
| 3 | NCT00041327 (ClinicalTrials.gov) | October 2002 | 8/7/2002 | Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/Lymphoma | Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's Lymphoma | Lymphoma | Biological: filgrastim;Biological: recombinant interferon alfa;Drug: Etoposide;Drug: cyclophosphamide;Drug: doxorubicin hydrochloride;Drug: lamivudine;Drug: prednisone;Drug: vincristine sulfate;Drug: zidovudine | AIDS Malignancy Consortium | National Cancer Institute (NCI) | Completed | 18 Years | 120 Years | Both | 19 | Phase 2 | United States |
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 | NCT04598477 (ClinicalTrials.gov) | July 15, 2021 | 8/10/2020 | A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus) | An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Pemphigus | Pemphigus Vulgaris;Pemphigus Foliaceus | Biological: efgartigimod PH20 SC;Drug: prednisone | argenx | NULL | Recruiting | 18 Years | N/A | All | 213 | Phase 3 | United States;Australia;Bulgaria;China;France;Georgia;Germany;Greece;Hungary;India;Israel;Italy;Japan;Poland;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;United Kingdom |
| 2 | EUCTR2020-002917-16-IT (EUCTR) | 17/12/2020 | 24/05/2021 | A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus) | An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Pemphigus - ADDRESS+ | Pemphigus Vulgaris or Pemphigus Foliaceus MedDRA version: 20.0;Level: LLT;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod PH20 SC Product Code: [na] INN or Proposed INN: EFGARTIGIMOD ALFA Other descriptive name: ARGX-113 Trade Name: Prednison 5 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednison 10 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednison20 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednison 50 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan | ||
| 3 | EUCTR2020-002915-23-IT (EUCTR) | 11/12/2020 | 24/05/2021 | A study to assess the safety and efficacy of a subcutaneous formulation of efgartigimod PH20 SC in adults with Pemphigus (Vulgaris or Foliaceus) | A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) (ADDRESS) - ADDRESS | Pemphigus Vulgaris or Pemphigus Foliaceus MedDRA version: 20.0;Level: LLT;Classification code 10057069;Term: Pemphigus foliaceus;System Organ Class: 100000004858 MedDRA version: 20.0;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prednison 50 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednison 5 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: prednisone Trade Name: Prednison20 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Product Name: Efgartigimod PH20 SC Product Code: [na] INN or Proposed INN: EFGARTIGIMOD ALFA Trade Name: Prednison 10 mg GALEN Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Poland;Romania;Australia;Georgia;Bulgaria;Germany;Japan | ||
| 4 | NCT04598451 (ClinicalTrials.gov) | December 1, 2020 | 8/10/2020 | A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus) | A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) | Pemphigus Vulgaris;Pemphigus Foliaceus | Biological: efgartigimod PH20 SC;Other: Placebo;Drug: prednisone | argenx | NULL | Active, not recruiting | 18 Years | N/A | All | 222 | Phase 3 | United States;Australia;Bulgaria;China;France;Georgia;Germany;Greece;Hungary;India;Israel;Italy;Japan;Poland;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;United Kingdom |
| 5 | ChiCTR1800020382 | 2019-01-01 | 2018-12-27 | Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus | Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus | Pemphigus | Group 1:Rituximab 500mg single infusion combined with routinedose of corticosteriods therapy;Group 2:Rituximab 100mg single infusion combined with routinedose of corticosteriods therapy;Group 3:Oral or intravenous infusion of routinedose of corticosteriods (prednisone or methylprednisolone); | West China Hospital, Sichuna University | NULL | Recruiting | 18 | 80 | Both | Group 1:14;Group 2:14;Group 3:14; | China | |
| 6 | EUCTR2018-001417-32-FR (EUCTR) | 13/07/2018 | 11/06/2018 | Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3 | Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3. Immunological, clinical and medicoeconomic evaluation | Patients with Bullous pemphigoid included in RITUXIMAB3 study MedDRA version: 20.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: MABTHERA INN or Proposed INN: RITUXIMAB Trade Name: Prednisone Product Name: CORTANCYL 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednisone Product Name: CORTANCYL 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | CHU-Hôpitaux de Rouen | NULL | Not Recruiting | Female: yes Male: yes | 77 | Phase 3 | France | ||
| 7 | 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 |
| 8 | ChiCTR-TRC-12003540 | 2011-08-01 | 2012-12-19 | Use of intravenous Methotrexate plus Glucocorticoid for the Treatment of Pemphigus:A multicenter,randomized and controlled clinical trial | Guideline-oriented Research in the Management of Some Common and Severe Skin Diseases | Pemphigus | Glucocorticoid group:This group receives systemic glucocorticoid, initially, with prednisone at 1mg/kg/day.;Glucocorticoid plus MTX group:This group receives systemic glucocorticoid plus MTX and starts with prednisone at 1mg/kg/day and MTX IV drip infusion at 15mg/week. Then we adjust the dose of glucocorticoid according to the patients' responses. ; | Institute of dermatology, Chinese Academyof Medical Sciences | NULL | Completed | 18 | 75 | Both | Glucocorticoid group:90;Glucocorticoid plus MTX group:90; | China | |
| 9 | ChiCTR-TRC-12003539 | 2011-08-01 | 2012-12-27 | Use of Oral Methotrexate plus Glucocorticoid for the Treatment of Pemphigus:A multicenter,randomized and controlled clinincal trial | Guideline-oriented Research in the Management of Some Common and Severe Skin Diseases | Pemphigus | Glucocorticoid hormone group:This group receives systemic glucocorticoid , initially ,with prednisone at 1mg/kg/day. Then we adjust the dose of glucocorticoid according to the patients' responses. ;Glucocorticoids joint methotrexate (MTX) group:This group receives systemic glucocorticoid plus MTX and starts with prednisone at 1mg/kg/day and MTX oral intake at 15mg/week. Then we adjust the dose of glucocorticoid according to the patients' responses. ; | Institute of dermatology, Chinese Academyof Medical Sciences | NULL | Completed | 18 | 75 | Both | Glucocorticoid hormone group:90;Glucocorticoids joint methotrexate (MTX) group:90; | China | |
| 10 | EUCTR2008-005266-31-FR (EUCTR) | 06/02/2009 | 13/03/2009 | COMPARAISON D'UN TRAITEMENT PAR L'ANTICORPS MONOCLONAL ANTI-CD 20 : RITUXIMAB (MABTHERA®) ASSOCIE A UNE CORTICOTHERAPIE GENERALE COURTE PAR RAPPORT A UNE CORTICOTHERAPIE GENERALE DE LONGUE DUREE CHEZ LES PATIENTS ATTEINTS DE PEMPHIGUS - Rituximab III | COMPARAISON D'UN TRAITEMENT PAR L'ANTICORPS MONOCLONAL ANTI-CD 20 : RITUXIMAB (MABTHERA®) ASSOCIE A UNE CORTICOTHERAPIE GENERALE COURTE PAR RAPPORT A UNE CORTICOTHERAPIE GENERALE DE LONGUE DUREE CHEZ LES PATIENTS ATTEINTS DE PEMPHIGUS - Rituximab III | Pemphogoide bulleuse MedDRA version: 9.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid | Trade Name: mabthéra Product Name: mathéra Trade Name: Prednisone Product Name: CORTANCYL 20 mg | CHU-Hôpitaux de Rouen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 11 | NCT00626678 (ClinicalTrials.gov) | January 2008 | 21/2/2008 | Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone | A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Adjuvant Azathioprine Therapy in New Cases of Pemphigus Vulgaris Receiving Prednisone | Pemphigus Vulgaris | Drug: Azathioprine;Drug: Prednisone;Drug: Placebo | Tehran University of Medical Sciences | NULL | Completed | 10 Years | 75 Years | Both | 48 | Phase 2 | Iran, Islamic Republic of |
| 12 | NCT00283712 (ClinicalTrials.gov) | March 2006 | 26/1/2006 | Use of Infliximab for the Treatment of Pemphigus Vulgaris | A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Infliximab in Subjects With Pemphigus Vulgaris Receiving Prednisone | Pemphigus | Drug: Infliximab;Other: Placebo Comparator | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Completed | 18 Years | N/A | All | 20 | Phase 2 | United States |
40. 高安動脈炎
臨床試験数 : 24 / 薬物数 : 40 - (DrugBank : 18) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 110
| 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 | NCT03550781 (ClinicalTrials.gov) | June 1, 2018 | 5/5/2018 | Anti-inflammatory Treatment for Inactive Takayasu Arteritis | Does Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory Treatment? | Takayasu Arteritis;Anti-Inflammatory Agents | Drug: Prednisone, cyclophosphamide | Chinese Academy of Medical Sciences, Fuwai Hospital | NULL | Not yet recruiting | 10 Years | 40 Years | All | 40 | Phase 2/Phase 3 | NULL |
| 2 | NCT00006055 (ClinicalTrials.gov) | March 2000 | 5/7/2000 | Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases | Purpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu Arteritis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation | Fairview University Medical Center | NULL | Active, not recruiting | 1 Year | 55 Years | Both | 10 | N/A | United States |
41. 巨細胞性動脈炎
臨床試験数 : 131 / 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125
| 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 | EUCTR2020-004809-31-SE (EUCTR) | 11/01/2022 | 21/10/2021 | Study of efficacy and safety of secukinumab 300 mg and 150 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cell arteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets, USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets, USP 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets, USP 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets, USP 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 348 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 2 | EUCTR2020-004809-31-DK (EUCTR) | 18/11/2021 | 01/08/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 3 | EUCTR2020-004809-31-NO (EUCTR) | 16/11/2021 | 28/06/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe Product Name: Cosentyx Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 4 | EUCTR2020-004809-31-BG (EUCTR) | 08/11/2021 | 26/08/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 20mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 5 | EUCTR2020-004809-31-DE (EUCTR) | 19/10/2021 | 12/07/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 6 | EUCTR2020-004809-31-PT (EUCTR) | 13/10/2021 | 07/07/2021 | Study of efficacy and safety of secukinumab 300 mg and 150 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with giant cell arteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 348 | Phase 3 | Russian Federation;United States;Czechia;Portugal;Sweden;Netherlands;Brazil;Guatemala;Poland;France;Bulgaria;Argentina;Hungary;United Kingdom;Switzerland;Spain;New Zealand;Canada;Turkey;Belgium;Norway;Finland;Denmark;South Africa;Italy;Australia;Germany;Estonia | ||
| 7 | EUCTR2020-004809-31-FI (EUCTR) | 05/10/2021 | 16/07/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 8 | EUCTR2020-004809-31-FR (EUCTR) | 24/09/2021 | 22/06/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx Product Name: Cosentyx Product Code: AIN457 INN or Proposed INN: SECUKINUMAB Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 9 | EUCTR2020-004809-31-IT (EUCTR) | 16/09/2021 | 22/10/2021 | Study of efficacy and safety of secukinumab 300 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with giant cell arteritis (GCA) - - | Giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Prednisone Product Name: Prednisone Product Code: [-] INN or Proposed INN: PREDNISONE Trade Name: Prednisone Product Name: Prednisone Product Code: [-] INN or Proposed INN: PREDNISONE Trade Name: Prednisone Product Name: Prednisone Product Code: [-] INN or Proposed INN: PREDNISONE Trade Name: Prednisone Product Name: Prednisone Product Code: [-] INN or Proposed INN: PREDNISONE Trade Name: Cosentyx Product Name: Cosentyx Product Code: [AIN457] INN or Proposed INN: SECUKINUMAB | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Portugal;Spain;Russian Federation;Italy;Switzerland;France;Denmark;Australia;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 10 | NCT03892785 (ClinicalTrials.gov) | January 27, 2020 | 26/3/2019 | MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial | MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial | Giant Cell Arteritis | Drug: Prednisone treatment;Drug: Tocilizumab treatment;Drug: Methotrexate treatment;Other: Questionnaires;Biological: Blood samples | Centre Hospitalier Universitaire Dijon | NULL | Recruiting | 50 Years | N/A | All | 230 | Phase 3 | France |
| 11 | EUCTR2017-002988-18-FI (EUCTR) | 02/10/2019 | 12/09/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | Portugal;Serbia;United States;Estonia;Spain;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Slovenia;Finland;Austria;United Kingdom;Hungary;Canada;Argentina;Belgium;Croatia;Germany;Norway;Sweden | ||
| 12 | EUCTR2017-002988-18-HR (EUCTR) | 15/04/2019 | 17/05/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 13 | EUCTR2018-001003-36-HR (EUCTR) | 10/04/2019 | 17/05/2019 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 14 | EUCTR2017-002988-18-SI (EUCTR) | 22/03/2019 | 19/12/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 15 | EUCTR2017-002988-18-GB (EUCTR) | 04/03/2019 | 20/06/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg | Sanofi-Aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Estonia;Slovenia;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;Switzerland;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 16 | EUCTR2018-001003-36-DE (EUCTR) | 27/02/2019 | 21/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 17 | EUCTR2017-002988-18-PT (EUCTR) | 25/02/2019 | 05/11/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 18 | EUCTR2017-002988-18-AT (EUCTR) | 19/02/2019 | 28/09/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 19 | EUCTR2017-002988-18-FR (EUCTR) | 14/01/2019 | 09/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 20 | NCT03711448 (ClinicalTrials.gov) | January 7, 2019 | 15/10/2018 | Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis | Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis | Patients Relapsing Refractory Giant Cell Arteritis | Drug: prednisone treatment;Drug: prednisone and ustekinumab treatment;Other: questionnaires;Biological: Blood samples | Centre Hospitalier Universitaire Dijon | NULL | Recruiting | 50 Years | N/A | All | 38 | Phase 2 | France |
| 21 | EUCTR2017-002988-18-DK (EUCTR) | 04/01/2019 | 29/09/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 22 | EUCTR2017-002988-18-NL (EUCTR) | 10/12/2018 | 01/11/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 23 | EUCTR2017-002988-18-BE (EUCTR) | 07/12/2018 | 06/03/2019 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 24 | EUCTR2018-001003-36-GB (EUCTR) | 06/12/2018 | 20/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: Prednisone Tablets, USP Product Code: N/A INN or Proposed INN: n/a Other descriptive name: PREDNISONE | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 25 | EUCTR2018-001003-36-IT (EUCTR) | 30/11/2018 | 11/10/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovenia;Spain;Ireland;Italy;United Kingdom;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 26 | NCT03726749 (ClinicalTrials.gov) | November 28, 2018 | 30/10/2018 | Tocilizumab Plus a Short Prednisone Taper for GCA | Tocilizumab Plus a Short Prednisone Taper for Giant Cell Arteritis (GCA) | Giant Cell Arteritis | Drug: Tocilizumab;Drug: Prednisone | Massachusetts General Hospital | Roche-Genentech | Recruiting | 50 Years | N/A | All | 30 | Phase 4 | United States |
| 27 | EUCTR2018-001003-36-BE (EUCTR) | 28/11/2018 | 16/08/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 28 | EUCTR2017-002988-18-DE (EUCTR) | 26/11/2018 | 26/09/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 29 | NCT03600805 (ClinicalTrials.gov) | November 20, 2018 | 17/7/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Sarilumab SAR153191;Drug: Sarilumab matching placebo;Drug: Prednisone;Drug: Prednisone matching placebo | Sanofi | Regeneron Pharmaceuticals | Terminated | 50 Years | N/A | All | 83 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Russian Federation;Slovenia;Spain;Sweden;Switzerland;United Kingdom;Austria;Finland |
| 30 | EUCTR2017-002988-18-HU (EUCTR) | 19/11/2018 | 04/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 31 | EUCTR2018-001003-36-NL (EUCTR) | 13/11/2018 | 29/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Netherlands;Germany;New Zealand | ||
| 32 | EUCTR2017-002988-18-IT (EUCTR) | 08/11/2018 | 12/02/2021 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate theefficacy and safety of sarilumab in patients with giant cell arteritis - n.a. | Giant Cell Arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® Product Name: NA Product Code: [NA] INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® Product Name: na Product Code: [na] INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg Product Name: NA Product Code: [NA] INN or Proposed INN: PREDNISONE Trade Name: Cortancyl ® 1 mg Product Name: na Product Code: [na] INN or Proposed INN: PREDNISONE Trade Name: Cortancyl ® 20 mg Product Name: NA Product Code: [NA] INN or Proposed INN: PREDNISONE Trade Name: Cortancyl ® 5 mg Product Name: NA Product Code: [NA] INN or Proposed INN: PREDNISONE | SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | Portugal;United States;Estonia;Slovenia;Finland;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 33 | EUCTR2017-002988-18-ES (EUCTR) | 19/10/2018 | 25/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | Portugal;United States;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 34 | EUCTR2017-002988-18-SE (EUCTR) | 18/10/2018 | 11/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Israel;Chile;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 35 | EUCTR2017-002988-18-EE (EUCTR) | 18/10/2018 | 15/10/2018 | Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA | A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis | Giant Cell Arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Kevzara ® INN or Proposed INN: SARILUMAB Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Cortancyl ® 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 508 | Phase 3 | United States;Portugal;Estonia;Slovenia;Finland;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 36 | EUCTR2018-001003-36-SI (EUCTR) | 03/10/2018 | 30/08/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 37 | NCT03827018 (ClinicalTrials.gov) | September 20, 2018 | 25/1/2019 | KPL-301 for Subjects With Giant Cell Arteritis | A Phase 2, Randomized, Double-blind Placebo-controlled Study to Test the Efficacy and Safety of KPL-301 in Giant Cell Arteritis | Giant Cell Arteritis | Combination Product: mavrilimumab;Combination Product: placebo;Drug: prednisone | Kiniksa Pharmaceuticals, Ltd. | NULL | Completed | 50 Years | 85 Years | All | 70 | Phase 2 | United States;Australia;Belgium;Croatia;Estonia;Germany;Ireland;Italy;Netherlands;New Zealand;Poland;Serbia;Slovenia;Spain;United Kingdom |
| 38 | EUCTR2018-001003-36-ES (EUCTR) | 08/08/2018 | 28/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 39 | EUCTR2018-001003-36-EE (EUCTR) | 09/07/2018 | 11/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 40 | NCT02955147 (ClinicalTrials.gov) | December 1, 2016 | 31/10/2016 | Ustekinumab for the Treatment of Giant Cell Arteritis | Open Label Study to Test the Safety and Efficacy of Ustekinumab in Patients With Giant Cell Arteritis | Giant Cell Arteritis;Temporal Arteritis;Horton's Disease | Drug: Ustekinumab;Drug: Prednisone | Massachusetts General Hospital | NULL | Terminated | 50 Years | N/A | All | 13 | Phase 1/Phase 2 | United States |
| 41 | EUCTR2015-001758-14-IT (EUCTR) | 08/06/2016 | 20/01/2021 | A study to assess the efficacy and safety of Sirukumab in the treatment ofpatients with Giant Cell Arteritis, using multiple sites, and an untreatedpatient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - NA | Giant Cell Arteritis (GCA) MedDRA version: 20.0;Level: SOC;Classification code 10047065;Term: Vascular disorders;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Trade Name: Capsule di prednisone INN or Proposed INN: PREDNISONE Trade Name: Prednisone Capsule INN or Proposed INN: PREDNISONE Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone capsule INN or Proposed INN: PREDNISONE Other descriptive name: Prednisone | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | New Zealand;Sweden;United States;Spain;United Kingdom;Italy;France;Hungary;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands | ||
| 42 | EUCTR2015-001758-14-HU (EUCTR) | 15/04/2016 | 19/01/2016 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA) MedDRA version: 20.0;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Encorton Product Name: Encorton INN or Proposed INN: prednisone Other descriptive name: PREDNISONE | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | ||
| 43 | EUCTR2015-001758-14-NL (EUCTR) | 04/02/2016 | 26/08/2015 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA) MedDRA version: 19.1;Level: SOC;Classification code 10047065;Term: Vascular disorders;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 44 | EUCTR2015-001758-14-BG (EUCTR) | 08/01/2016 | 21/10/2015 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA) MedDRA version: 19.0;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | ||
| 45 | EUCTR2015-001758-14-DE (EUCTR) | 18/12/2015 | 15/07/2015 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA) MedDRA version: 19.1;Level: HLGT;Classification code 10047116;Term: Vascular inflammations;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Belgium;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand | ||
| 46 | EUCTR2015-001758-14-BE (EUCTR) | 14/12/2015 | 05/02/2016 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | ||
| 47 | NCT02531633 (ClinicalTrials.gov) | October 16, 2015 | 6/7/2015 | Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Sirukumab;Drug: Placebo to match sirukumab;Drug: Prednisone;Drug: Placebo to match prednisone | GlaxoSmithKline | NULL | Terminated | 50 Years | N/A | All | 161 | Phase 3 | United States;Australia;Belgium;Bulgaria;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Spain;United Kingdom |
| 48 | EUCTR2015-001758-14-ES (EUCTR) | 30/09/2015 | 31/07/2015 | A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy and Safety ofSirukumab in the Treatment of Patients with Giant Cell Arteritis - Not Applicable | Giant Cell Arteritis (GCA);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Product Name: Sirukumab Product Code: GSK2973327 INN or Proposed INN: Sirukumab Other descriptive name: CNTO 136 Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone Trade Name: Prednisone Capsules Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Over encapsulated prednisone | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Hungary;Poland;Belgium;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | ||
| 49 | EUCTR2011-006022-25-NL (EUCTR) | 09/10/2013 | 24/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 17.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: TOCILIZUMAB SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 50 | EUCTR2011-006022-25-BE (EUCTR) | 30/09/2013 | 17/06/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 51 | EUCTR2011-006022-25-PL (EUCTR) | 09/09/2013 | 16/07/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 19.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 52 | NCT01791153 (ClinicalTrials.gov) | July 22, 2013 | 12/2/2013 | An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA) | A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Tocilizumab;Drug: Prednisone;Drug: Tocilizumab Placebo;Drug: Prednisone Placebo;Drug: Corticosteroids;Drug: Methotrexate | Hoffmann-La Roche | NULL | Completed | 50 Years | N/A | All | 251 | Phase 3 | United States;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Spain;Sweden;United Kingdom;Austria |
| 53 | EUCTR2011-006022-25-ES (EUCTR) | 24/06/2013 | 10/06/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 16.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Spain;Austria;Italy;United Kingdom;France;Canada;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 54 | EUCTR2011-006022-25-DK (EUCTR) | 14/06/2013 | 14/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden;United States;Spain;Portugal | ||
| 55 | EUCTR2011-006022-25-PT (EUCTR) | 07/06/2013 | 22/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 56 | EUCTR2011-006022-25-DE (EUCTR) | 06/06/2013 | 13/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 57 | EUCTR2011-006022-25-GB (EUCTR) | 23/05/2013 | 15/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 19.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 58 | EUCTR2011-006022-25-SE (EUCTR) | 16/05/2013 | 07/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 59 | EUCTR2011-006022-25-AT (EUCTR) | 14/05/2013 | 10/05/2013 | A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 17.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 60 | EUCTR2011-006022-25-IT (EUCTR) | 05/05/2013 | 07/03/2013 | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS | Giant cell arteritis (GCA) MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Spain;Austria;Italy;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 61 | EUCTR2011-005090-22-GB (EUCTR) | 28/02/2012 | 17/01/2012 | A study of the effectiveness and safety of delayed release prednisone in patients with newly diagnosed Giant Cell Arteritis | A study of efficacy and safety of delayed release prednisone in newly diagnosed cases of Giant Cell Arteritis - Efficacy and safety of delayed release prednisone in GCA | Giant Cell Arteritis MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Trade Name: Lodotra Product Name: Lodotra (delayed release prednisolone) INN or Proposed INN: Prednisolone Other descriptive name: 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione | Southend Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom | ||||
| 62 | NCT01400464 (ClinicalTrials.gov) | July 2009 | 21/7/2011 | Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis | Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis | Giant Cell Arteritis | Drug: Prednisone therapy and pharmacokinetic | University Hospital, Caen | NULL | Active, not recruiting | 50 Years | N/A | Both | 150 | Phase 4 | France |
| 63 | NCT00006055 (ClinicalTrials.gov) | March 2000 | 5/7/2000 | Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases | Purpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu Arteritis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation | Fairview University Medical Center | NULL | Active, not recruiting | 1 Year | 55 Years | Both | 10 | N/A | United States | |
| 64 | NCT00004686 (ClinicalTrials.gov) | February 1994 | 24/2/2000 | Phase II Randomized Study of Glucocorticoids With or Without Methotrexate for Treatment of Giant Cell Arteritis | Giant Cell Arteritis | Drug: methotrexate;Drug: prednisone | The Cleveland Clinic | NULL | Completed | 50 Years | N/A | Both | 300 | Phase 2 | NULL |
42. 結節性多発動脈炎
臨床試験数 : 15 / 薬物数 : 26 - (DrugBank : 16) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 105
| 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 | NCT00307671 (ClinicalTrials.gov) | July 2005 | 27/3/2006 | Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years | Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants | Vasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis;Churg-Strauss Syndrome;Polyarteritis Nodosa | Drug: prednisone, methylprednisolone,cyclophosphamides;Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone;Drug: Mycophenolate mofetil,methotrexate | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 65 Years | N/A | Both | 108 | Phase 4 | France |
| 2 | NCT00006055 (ClinicalTrials.gov) | March 2000 | 5/7/2000 | Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases | Purpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu Arteritis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation | Fairview University Medical Center | NULL | Active, not recruiting | 1 Year | 55 Years | Both | 10 | N/A | United States |
43. 顕微鏡的多発血管炎
臨床試験数 : 88 / 薬物数 : 81 - (DrugBank : 21) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 90
| 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 | EUCTR2018-000768-27-IE (EUCTR) | 26/08/2019 | 20/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2018-000768-27-DK (EUCTR) | 05/08/2019 | 20/03/2019 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2018-000768-27-GB (EUCTR) | 17/04/2019 | 27/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) - InflaRx GmbH_IFX-1-P2.5 | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: PredniSONE Tablets, USP INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 2 | Spain;Ireland;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 4 | EUCTR2018-000768-27-BE (EUCTR) | 04/04/2019 | 01/05/2019 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 20.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE Trade Name: GALEN® tablet Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | France;Czech Republic;Spain;Belgium;Ireland;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2018-000768-27-DE (EUCTR) | 11/03/2019 | 19/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: Vilobelimab Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 6 | EUCTR2018-000768-27-NL (EUCTR) | 10/03/2019 | 20/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: Vilobelimab Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE Trade Name: GALEN® tablet Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 7 | EUCTR2018-000768-27-IT (EUCTR) | 27/02/2019 | 24/05/2021 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) - Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients wit | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) Product Code: [Glucocorticoids (GC)] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: GALEN® tablet Product Name: Glucocorticoids (GC) Product Code: [Glucocorticoids (GC)] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Product Name: IFX-1 Product Code: [IFX-1] INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Czechia;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 8 | EUCTR2018-000768-27-SE (EUCTR) | 08/02/2019 | 19/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: Vilobelimab Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | Spain;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Czechia;Sweden | ||
| 9 | EUCTR2018-000768-27-ES (EUCTR) | 17/01/2019 | 18/01/2019 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 20.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE Trade Name: GALEN® tablet Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | France;Czech Republic;Belgium;Spain;Ireland;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 10 | EUCTR2018-000768-27-CZ (EUCTR) | 10/01/2019 | 19/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: Vilobelimab Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 11 | EUCTR2016-001121-14-NO (EUCTR) | 06/10/2017 | 07/02/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;New Zealand;Sweden | ||
| 12 | EUCTR2016-001121-14-NL (EUCTR) | 15/06/2017 | 18/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 13 | EUCTR2016-001121-14-BE (EUCTR) | 08/05/2017 | 06/02/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 14 | EUCTR2016-001121-14-IT (EUCTR) | 04/05/2017 | 07/01/2021 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCAAssociated Vasculitis (AAV). | Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Trade Name: Prednison acis¿ 5 mg Product Name: Prednisone INN or Proposed INN: PREDNISONE Trade Name: Prednison acis¿ 20 mg | CHEMOCENTRYX, INC. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 15 | EUCTR2016-001121-14-HU (EUCTR) | 24/04/2017 | 23/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 16 | EUCTR2016-001121-14-DK (EUCTR) | 07/04/2017 | 01/02/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden | ||
| 17 | EUCTR2016-001121-14-GB (EUCTR) | 06/04/2017 | 23/12/2016 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Hungary;United States;United Kingdom;Switzerland;Spain;New Zealand;Canada;Austria;Czech Republic;Netherlands;Sweden;Belgium;Norway;Ireland;Denmark;Italy;Australia;France;Germany | ||
| 18 | EUCTR2016-001121-14-ES (EUCTR) | 21/03/2017 | 20/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 19 | EUCTR2016-001121-14-CZ (EUCTR) | 20/03/2017 | 12/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 20 | EUCTR2016-001121-14-AT (EUCTR) | 13/02/2017 | 10/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: prednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 21 | EUCTR2016-001121-14-SE (EUCTR) | 13/02/2017 | 21/12/2016 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 22 | EUCTR2009-013220-24-IT (EUCTR) | 22/01/2010 | 10/12/2009 | Plasma exchange and glucocorticoid dosing in the treatment of ANCA-associated vasculitis: a multicentre randomized controlled tria - PEXIVAS | Plasma exchange and glucocorticoid dosing in the treatment of ANCA-associated vasculitis: a multicentre randomized controlled tria - PEXIVAS | Acute renal severe to moderate failure with Wegener`s Granulomatosis or microscopic polyangiitis MedDRA version: 9.1;Level: HLGT;Classification code 10003816 MedDRA version: 9.1;Level: LLT;Classification code 10018378 | Trade Name: DELTACORTENE INN or Proposed INN: Prednisone Trade Name: DELTACORTENE INN or Proposed INN: Prednisone | AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Czech Republic;Poland;Spain;Denmark;United Kingdom;Italy;Sweden | ||
| 23 | NCT00307671 (ClinicalTrials.gov) | July 2005 | 27/3/2006 | Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years | Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants | Vasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis;Churg-Strauss Syndrome;Polyarteritis Nodosa | Drug: prednisone, methylprednisolone,cyclophosphamides;Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone;Drug: Mycophenolate mofetil,methotrexate | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 65 Years | N/A | Both | 108 | Phase 4 | France |
| 24 | NCT00104299 (ClinicalTrials.gov) | January 2005 | 24/2/2005 | Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis | Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI) | Vasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis | Drug: Rituximab plus cyclophosphamide placebo (rituximab group);Drug: Cyclophosphamide plus rituximab placebo (control group);Drug: Azathioprine;Drug: Methylprednisolone (or other glucocorticoid);Drug: Prednisone | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN);Genentech, Inc. | Completed | 15 Years | N/A | All | 197 | Phase 2/Phase 3 | United States;Netherlands |
| 25 | NCT00307645 (ClinicalTrials.gov) | May 2003 | 27/3/2006 | IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis | Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis | ANCA Associated Systemic Vasculitis Including Wegener’s;Granulomatosis and Microscopic Polyangiitis and;Renal Limited Vasculitis | Drug: Cyclophosphamide;Drug: Mycophenolate mofetil;Drug: Azathioprine;Drug: Prednisone (and methylprednisolone) | Assistance Publique - Hôpitaux de Paris | NULL | Terminated | 18 Years | N/A | Both | 160 | Phase 3 | France;United Kingdom |
| 26 | EUCTR2016-001121-14-IE (EUCTR) | 21/12/2016 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | |||
| 27 | EUCTR2016-001121-14-FR (EUCTR) | 22/06/2018 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | |||
| 28 | EUCTR2016-001121-14-DE (EUCTR) | 23/12/2016 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 21.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden |
44. 多発血管炎性肉芽腫症
臨床試験数 : 98 / 薬物数 : 108 - (DrugBank : 28) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 81
| 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 | EUCTR2018-000768-27-IE (EUCTR) | 26/08/2019 | 20/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2018-000768-27-DK (EUCTR) | 05/08/2019 | 20/03/2019 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2018-000768-27-GB (EUCTR) | 17/04/2019 | 27/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) - InflaRx GmbH_IFX-1-P2.5 | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: PredniSONE Tablets, USP INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 2 | Spain;Ireland;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 4 | EUCTR2018-000768-27-BE (EUCTR) | 04/04/2019 | 01/05/2019 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 20.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE Trade Name: GALEN® tablet Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | France;Czech Republic;Spain;Belgium;Ireland;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2018-000768-27-DE (EUCTR) | 11/03/2019 | 19/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: Vilobelimab Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 6 | EUCTR2018-000768-27-NL (EUCTR) | 10/03/2019 | 20/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: Vilobelimab Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE Trade Name: GALEN® tablet Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 7 | EUCTR2018-000768-27-IT (EUCTR) | 27/02/2019 | 24/05/2021 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) - Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients wit | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) Product Code: [Glucocorticoids (GC)] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: GALEN® tablet Product Name: Glucocorticoids (GC) Product Code: [Glucocorticoids (GC)] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Product Name: IFX-1 Product Code: [IFX-1] INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Czechia;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 8 | EUCTR2018-000768-27-SE (EUCTR) | 08/02/2019 | 19/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: Vilobelimab Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | Spain;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Czechia;Sweden | ||
| 9 | EUCTR2018-000768-27-ES (EUCTR) | 17/01/2019 | 18/01/2019 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 20.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE Trade Name: GALEN® tablet Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | France;Czech Republic;Belgium;Spain;Ireland;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 10 | EUCTR2018-000768-27-CZ (EUCTR) | 10/01/2019 | 19/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: Vilobelimab Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 11 | EUCTR2016-001121-14-NO (EUCTR) | 06/10/2017 | 07/02/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;New Zealand;Sweden | ||
| 12 | EUCTR2016-001121-14-NL (EUCTR) | 15/06/2017 | 18/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 13 | EUCTR2016-001121-14-BE (EUCTR) | 08/05/2017 | 06/02/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 14 | EUCTR2016-001121-14-IT (EUCTR) | 04/05/2017 | 07/01/2021 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCAAssociated Vasculitis (AAV). | Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Trade Name: Prednison acis¿ 5 mg Product Name: Prednisone INN or Proposed INN: PREDNISONE Trade Name: Prednison acis¿ 20 mg | CHEMOCENTRYX, INC. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 15 | EUCTR2016-001121-14-HU (EUCTR) | 24/04/2017 | 23/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 16 | EUCTR2016-001121-14-DK (EUCTR) | 07/04/2017 | 01/02/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden | ||
| 17 | EUCTR2016-001121-14-GB (EUCTR) | 06/04/2017 | 23/12/2016 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Hungary;United States;United Kingdom;Switzerland;Spain;New Zealand;Canada;Austria;Czech Republic;Netherlands;Sweden;Belgium;Norway;Ireland;Denmark;Italy;Australia;France;Germany | ||
| 18 | EUCTR2016-001121-14-ES (EUCTR) | 21/03/2017 | 20/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 19 | EUCTR2016-001121-14-CZ (EUCTR) | 20/03/2017 | 12/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 20 | EUCTR2016-001121-14-AT (EUCTR) | 13/02/2017 | 10/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: prednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 21 | EUCTR2016-001121-14-SE (EUCTR) | 13/02/2017 | 21/12/2016 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 22 | NCT01933724 (ClinicalTrials.gov) | February 17, 2014 | 28/8/2013 | The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach | The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach | Granulomatosis With Polyangiitis;Wegener Granulomatosis;Vasculitis | Drug: 5 mg prednisone;Drug: 0 mg prednisone | University of South Florida | National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Rare Diseases (ORD);National Center for Advancing Translational Sciences (NCATS);Rare Diseases Clinical Research Network | Active, not recruiting | 18 Years | N/A | All | 12 | Phase 3 | United States |
| 23 | NCT01940094 (ClinicalTrials.gov) | February 2014 | 6/9/2013 | The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach | The Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence Approach | Granulomatosis With Polyangiitis | Drug: 5 mg Prednisone;Drug: 0 mg Prednisone | University of Pennsylvania | National Heart, Lung, and Blood Institute (NHLBI);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Rare Diseases (ORD);National Center for Advancing Translational Sciences (NCATS);Rare Diseases Clinical Research Network | Recruiting | 18 Years | N/A | All | 159 | Phase 3 | United States;Canada |
| 24 | EUCTR2016-001121-14-IE (EUCTR) | 21/12/2016 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | |||
| 25 | EUCTR2016-001121-14-FR (EUCTR) | 22/06/2018 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | |||
| 26 | EUCTR2016-001121-14-DE (EUCTR) | 23/12/2016 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 21.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden |
45. 好酸球性多発血管炎性肉芽腫症
臨床試験数 : 31 / 薬物数 : 44 - (DrugBank : 18) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 101
| 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 | NCT00424749 (ClinicalTrials.gov) | June 2007 | 19/1/2007 | Rituxan in Churg Strauss Syndrome With Renal Involvement | A Pilot Study on the Use of Rituximab in the Treatment of Churg- Strauss Syndrome With Renal Involvement | Churg-Strauss Syndrome | Drug: Rituximab;Drug: Prednisone | Fernando Fervenza | Genentech, Inc.;Biogen;National Center for Research Resources (NCRR) | Terminated | 18 Years | N/A | All | 4 | Phase 2 | United States |
| 2 | NCT00307671 (ClinicalTrials.gov) | July 2005 | 27/3/2006 | Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years | Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants | Vasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis;Churg-Strauss Syndrome;Polyarteritis Nodosa | Drug: prednisone, methylprednisolone,cyclophosphamides;Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone;Drug: Mycophenolate mofetil,methotrexate | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 65 Years | N/A | Both | 108 | Phase 4 | France |
| 3 | NCT00006055 (ClinicalTrials.gov) | March 2000 | 5/7/2000 | Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases | Purpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu Arteritis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation | Fairview University Medical Center | NULL | Active, not recruiting | 1 Year | 55 Years | Both | 10 | N/A | 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 | NCT05651373 (ClinicalTrials.gov) | July 30, 2021 | 15/11/2022 | The Clinical Features and Pregnancy Outcomes of RA Patients | The Clinical Features and Pregnancy Outcomes of Patients With Rheumatoid Arthritis :a Prospective Cohort Study | Rheumatoid Arthritis;Pregnancy Related | Drug: Prednisone;Drug: Hydroxychloroquine;Drug: CertolizumabPegol injection | Qilu Hospital of Shandong University | NULL | Recruiting | 20 Years | 45 Years | Female | 100 | China | |
| 2 | ITMCTR2100005066 | 2021-07-15 | 2021-07-16 | A prospective non-randomized controlled study on the treatment of interstitial pneumonia of RA with Peitushengjinjiedutongluo method | A prospective cohort study on the treatment of interstitial pneumonia of RA with Peitushengjinjiedutongluo method | Rheumatoid arthritis with interstitial pneumonia | control group:Hydroxychloroquine + prednisone;experimental group:Syndrome Differentiation and Flavoring of Peitushengjin Chinese Medicine Granules; | Zhejiang Chinese Medical University | NULL | Pending | 18 | 65 | Both | control group:240;experimental group:285; | N/A | China |
| 3 | ChiCTR2100048802 | 2021-07-15 | 2021-07-16 | A prospective non-randomized controlled study on the treatment of interstitial pneumonia of RA with Peitushengjinjiedutongluo method | A prospective cohort study on the treatment of interstitial pneumonia of RA with Peitushengjinjiedutongluo method | Rheumatoid arthritis with interstitial pneumonia | experimental group:Syndrome Differentiation and Flavoring of Peitushengjin Chinese Medicine Granules;control group:Hydroxychloroquine + prednisone; | Zhejiang Chinese Medical University | NULL | Pending | 18 | 65 | Both | experimental group:285;control group:240; | N/A | China |
| 4 | ChiCTR2100041909 | 2021-01-01 | 2021-01-09 | Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome) | Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome) | Rheumatoid arthritis | Treatment group:Yupingfengguizhi solution, Prednisone Acetate Tablets, Methotrexate, Leflunomide ;control group:Prednisone Acetate Tablets, Methotrexate, Leflunomide; | Yunnan Traditional Chinese Medicine Hospital | NULL | Recruiting | 18 | 65 | Both | Treatment group:62;control group:31; | China | |
| 5 | ChiCTR2100041777 | 2021-01-01 | 2021-01-05 | Clinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritis | Clinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritis | rheumatoid arthritis | Treatment group:Juanbi granule, Prednisone Acetate Tablets, Methotrexate and Leflunomide ;control group:Prednisone Acetate Tablets, Methotrexate and Leflunomide; | Yunnan Hospital of Traditional Chinese Medicine /The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | Treatment group:62;control group:31; | China | |
| 6 | ITMCTR2100004610 | 2021-01-01 | 2021-01-05 | Clinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritis | Clinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritis | rheumatoid arthritis | control group:Prednisone Acetate Tablets, Methotrexate and Leflunomide;Treatment group:Juanbi granule, Prednisone Acetate Tablets, Methotrexate and Leflunomide ; | Yunnan Hospital of Traditional Chinese Medicine /The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | control group:31;Treatment group:62; | China | |
| 7 | ITMCTR2100004239 | 2021-01-01 | 2021-01-09 | Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome) | Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome) | Rheumatoid arthritis | control group:Prednisone Acetate Tablets, Methotrexate, Leflunomide;Treatment group:Yupingfengguizhi solution, Prednisone Acetate Tablets, Methotrexate, Leflunomide ; | Yunnan Traditional Chinese Medicine Hospital | NULL | Recruiting | 18 | 65 | Both | control group:31;Treatment group:62; | China | |
| 8 | NCT04569890 (ClinicalTrials.gov) | December 1, 2020 | 20/9/2020 | Treatment of Pregnancy RA | Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China | Rheumatoid Arthritis;Pregnancy Related | Drug: Certolizumab Pegol 200 MG/ML [Cimzia];Drug: Hydroxychloroquine;Drug: Prednisone | RenJi Hospital | NULL | Not yet recruiting | 20 Years | 40 Years | Female | 100 | N/A | China |
| 9 | EUCTR2018-004287-56-FR (EUCTR) | 21/11/2019 | 31/01/2020 | Methotrexate and Metformin in rheumatoid arthritis patients | Randomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study - METorMET2 | rheumatoid arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: METFORMINE ARROW 500mg Product Name: Metformin Trade Name: Methotrexate Product Name: Methotrexate Trade Name: Methotrexate Product Name: Methotrexate Trade Name: Acide folique Product Name: Acide folique Product Code: B03BB01 Trade Name: Prednisone Product Name: Prednisone Product Code: H02AB07 | CHU de Bordeaux | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France | ||
| 10 | EUCTR2017-003037-28-NL (EUCTR) | 02/10/2019 | 22/07/2019 | Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs. | Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs. - TOPIRA | RA patients with active RA despite treatment with DMARDs. MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE INN or Proposed INN: PREDNISOLONE Other descriptive name: Prednisolone | University Medical Center Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Netherlands | ||
| 11 | EUCTR2016-001618-18-FR (EUCTR) | 08/07/2016 | 09/06/2016 | Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients | STARComparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission - STAR | glucocorticoid withdrawal in rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prednisone Product Name: prednisone 5 mg Trade Name: Prednisone Product Name: prednisone 4 mg Trade Name: Prednisone Product Name: prednisone 3 mg Trade Name: Prednisone Product Name: prednisone 2 mg Trade Name: Prednisone Product Name: prednisone 1 mg Trade Name: Hydrocortisone 10mg | CHU Toulouse | NULL | Not Recruiting | Female: yes Male: yes | 122 | Phase 4 | France | ||
| 12 | NCT02573012 (ClinicalTrials.gov) | March 29, 2016 | 1/10/2015 | Study to Compare the Efficacy of Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Participants | Prospective, Multicentre, Placebo-controlled, Double-blind Interventional Study to Compare the Efficacy of Maintenance Treatment With Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Placebo matched to prednisone;Drug: Prednisone;Biological: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 314 | Phase 4 | France;Germany;Italy;Russian Federation;Serbia;Tunisia;Egypt;Switzerland;Turkey |
| 13 | EUCTR2014-004673-16-DE (EUCTR) | 12/01/2016 | 15/07/2015 | Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis. | Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg Product Code: RO001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg Product Code: RO 001-9265/F02-01 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: RoActemra Product Code: L04AC07 INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 226 | Phase 4 | Serbia;France;Egypt;Lebanon;Turkey;Russian Federation;Germany;Italy;Switzerland | ||
| 14 | EUCTR2014-004673-16-FR (EUCTR) | 16/11/2015 | 05/08/2015 | Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis. | Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg Product Code: RO001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg Product Code: RO 001-9265/F02-01 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 226 | Phase 4 | Serbia;Egypt;France;Slovenia;Lebanon;Turkey;Russian Federation;Germany;Tunisia;Italy;Switzerland | ||
| 15 | NCT02451748 (ClinicalTrials.gov) | August 2015 | 6/5/2015 | IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA | IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA | Rheumatoid Arthritis | Other: Lab Work;Drug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg);Drug: Certolizumab pegol (CDP870, tradename Cimzia);Drug: Hydroxychloroquine;Drug: Sulfasalazine;Drug: Medrol;Drug: Prednisone;Drug: Triamcinolone;Drug: Naproxen;Drug: Leflunomide;Drug: Methotrexate;Drug: humira | University of Illinois at Chicago | UCB Pharma | Completed | 18 Years | N/A | All | 32 | Phase 4 | United States |
| 16 | EUCTR2014-004673-16-IT (EUCTR) | 27/07/2015 | 04/06/2021 | Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis. | PROSPECTIVE, MULTICENTRE, PLACEBO CONTROLLED, DOUBLE-BLIND STUDY TO COMPARE THE EFFICACY OF MAINTENANCE TREATMENT WITH TOCILIZUMAB WITH OR WITHOUT GLUCOCORTICOID DISCONTINUATION IN RHEUMATOID ARTHRITIS PATIENTS - NA | Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ROACTEMRA - 162 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA 0,9ML (VETRO) - 4 SIRINGHE PRERIEMPITE Product Name: NA Product Code: RO487-7533/F10-04 INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Encorton, 5 mg, tablets INN or Proposed INN: PREDNISONE | F. HOFFMANN - LA ROCHE LTD. | NULL | Not Recruiting | Female: yes Male: yes | 226 | Phase 4 | France;Serbia;Egypt;Lebanon;Turkey;Russian Federation;Germany;Switzerland;Italy | ||
| 17 | NCT02287610 (ClinicalTrials.gov) | November 2014 | 6/11/2014 | A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis | A Non-Interventional Study to Evaluate the Effectiveness of Delayed-Release Prednisone (RAYOS) on Clinical Assessments and Serologic Disease Activity in Patients With Active Rheumatoid Arthritis in the Clinical Practice Setting | Rheumatoid Arthritis | Drug: RAYOS (delayed-release prednisone) | Horizon Pharma Ireland, Ltd., Dublin Ireland | NULL | Completed | 18 Years | N/A | All | 75 | N/A | NULL |
| 18 | ChiCTR1900026116 | 2014-06-01 | 2019-09-22 | The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trial | The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trial | rheumatoid arthritis | Experimental group:Prednisone+methotrexate+Hydrochloroquine;control group:placebo+methotrexate+Hydrochloroquine; | Central Hospital of Jinhua | NULL | Completed | 21 | 73 | Both | Experimental group:40;control group:40; | Phase 4 | China |
| 19 | EUCTR2013-003658-26-NL (EUCTR) | 13/11/2013 | 18/10/2013 | Individualised treatment strategy based on disease activity for early RA patients in usual clinical practice: The COBRA Cohort Study | Treat-to-target strategy for early RA patients in usual clinical practice: The COBRA Cohort Study - COBRA Cohort Study | Early Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Prednison Product Name: Prednison INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Plaquenil Product Name: hydroxycholoquine INN or Proposed INN: hydroxychloroquine sulfate Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: Sulfasalazine Product Name: Sulfasalazine INN or Proposed INN: Sulfasalazine Other descriptive name: SULFASALAZINE | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 20 | NCT02072200 (ClinicalTrials.gov) | September 2013 | 14/2/2014 | Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE) | A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning Stiffness | Rheumatoid Arthritis | Drug: Lodotra® | Mundipharma Korea Ltd | NULL | Completed | 20 Years | 80 Years | All | 147 | Phase 4 | Korea, Republic of |
| 21 | EUCTR2011-002392-41-BG (EUCTR) | 09/04/2012 | 07/02/2012 | A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis. | A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® Product Name: Prednisone INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria | ||
| 22 | EUCTR2011-002392-41-HU (EUCTR) | 28/03/2012 | 16/12/2011 | A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis. | A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Prednisolone INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® Product Name: Prednisone INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria | ||
| 23 | NCT01612377 (ClinicalTrials.gov) | March 2012 | 22/2/2012 | Long Term Safety Trial of z102 and Prednisone in Patients With Moderate to Severe Rheumatoid Arthritis | A Phase II, Double-blind, Controlled, Multi-center, Randomized, Long Term Safety Trial of z102 and Prednisone (5 mg or 7.5 mg) in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisolone-Dipyridamole;Drug: Prednisone;Drug: prednisone | Zalicus | NULL | Terminated | 18 Years | N/A | Both | 18 | Phase 2 | Serbia |
| 24 | EUCTR2010-023782-22-SK (EUCTR) | 25/01/2012 | 07/10/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 16.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 INN or Proposed INN: Not available Product Code: PF-04171327 INN or Proposed INN: Not available Product Code: PF-04171327 INN or Proposed INN: Not available Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 315 | Phase 2 | Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Hungary;Czech Republic;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 25 | EUCTR2010-023782-22-BG (EUCTR) | 21/12/2011 | 21/05/2012 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 15.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Hungary;Czech Republic;Mexico;Canada;Malaysia;Poland;Romania;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 26 | EUCTR2010-023782-22-ES (EUCTR) | 16/12/2011 | 20/07/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 14.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer, S.L.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 315 | Phase 2 | Hungary;Colombia;Germany;Malaysia;Bulgaria;South Africa;India;Slovakia;Russian Federation;Czech Republic;Ukraine;Serbia;Canada;Mexico;Korea, Republic of;Romania;Spain;United States;Poland | ||
| 27 | EUCTR2010-023782-22-DE (EUCTR) | 13/12/2011 | 16/09/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 16.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 INN or Proposed INN: na Product Code: PF-04171327 INN or Proposed INN: na Product Code: PF-04171327 INN or Proposed INN: na Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 28 | EUCTR2011-000436-28-PL (EUCTR) | 07/12/2011 | 20/06/2011 | A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis. | A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole Product Code: Dipyridamole INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Serbia;Hungary;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Chile;Bulgaria;Russian Federation | ||
| 29 | EUCTR2010-023782-22-HU (EUCTR) | 22/11/2011 | 27/09/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 14.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 30 | EUCTR2011-000436-28-BG (EUCTR) | 07/10/2011 | 06/10/2011 | A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis. | A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole Product Code: Dipyridamole INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria | ||
| 31 | NCT04169100 (ClinicalTrials.gov) | September 28, 2011 | 14/11/2019 | Novel Form of Acquired Long QT Syndrome | Novel Form of Acquired Long QT Syndrome | Long QT Syndrome;Connective Tissue Diseases;Rheumatoid Arthritis | Drug: Prednisone | Narrows Institute for Biomedical Research | VA New York Harbor Healthcare System | Recruiting | 18 Years | 89 Years | All | 25 | Phase 4 | United States |
| 32 | EUCTR2010-023782-22-CZ (EUCTR) | 21/09/2011 | 01/08/2011 | A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG | A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG | Rheumatoid Arthritis MedDRA version: 16.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: PF-04171327 Product Code: PF-04171327 Product Code: PF-04171327 Trade Name: Decortin INN or Proposed INN: PREDNISONE | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | United States;Serbia;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 33 | NCT01393639 (ClinicalTrials.gov) | September 2011 | 13/6/2011 | Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis | A Phase 2, Randomized, Double Blind Assessment Of Efficacy And Safety Of Pf 04171327(1, 5, 10, 15 Mg Dose, Daily) Compared To 5 Mg And 10 Mg Prednisone Daily And Placebo Daily In Subjects With Rheumatoid Arthritis Over An 8 Week Period Followed By A 4 Week Period Of Tapering Of Study Drug. | Rheumatoid Arthritis | Drug: PF-04171327;Drug: prednisone;Other: prednisone;Other: placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 323 | Phase 2 | United States;Bulgaria;Colombia;Czechia;Germany;Hungary;India;Korea, Republic of;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;Canada;Czech Republic |
| 34 | EUCTR2011-000436-28-HU (EUCTR) | 02/08/2011 | 10/08/2011 | A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis. | A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS | Treatment of patients with moderate to severe rheumatoid arthritis (RA) MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Z102 Product Code: Z102 INN or Proposed INN: Z102 (Prednisolone and Dipyridamole). Product Name: Prednisolone Product Code: Prednisolone INN or Proposed INN: Prednisolone Product Name: Dipyridamole Product Code: Dipyridamole INN or Proposed INN: Dipyridamole Trade Name: Dacortin ® INN or Proposed INN: PREDNISONE | Zalicus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria | ||
| 35 | NCT01369745 (ClinicalTrials.gov) | June 2011 | 7/6/2011 | A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis | A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisolone;Drug: dipyridamole;Drug: Prednisone;Drug: Z102;Other: placebo | Zalicus | NULL | Completed | 18 Years | N/A | All | 294 | Phase 2 | United States |
| 36 | EUCTR2009-013223-37-ES (EUCTR) | 25/11/2009 | 17/09/2009 | Estudio en fase 2a, aleatorizado, doble ciego, controlado con un fármaco activo y con placebo, de PF-04171327 en el tratamiento de los signos y síntomas de la artritis reumatoideA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS | Estudio en fase 2a, aleatorizado, doble ciego, controlado con un fármaco activo y con placebo, de PF-04171327 en el tratamiento de los signos y síntomas de la artritis reumatoideA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS | ARTRITIS REUMATOIDE MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: PF-04171327 Product Code: PF-04171327 Product Name: PF-04171327 Product Code: PF-04171327 Trade Name: DECORTIN (PREDNISONA) 5 MG COMPRIMIDOS INN or Proposed INN: Prednisone Other descriptive name: Decortin® | Pfizer S.A. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | Hungary;Czech Republic;Spain | ||
| 37 | EUCTR2009-013223-37-CZ (EUCTR) | 10/11/2009 | 17/08/2009 | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: PF-04171327 Product Code: PF-04171327 Product Name: PF-04171327 Product Code: PF-04171327 INN or Proposed INN: Prednisone Other descriptive name: Decortin® | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | Hungary;Czech Republic;Spain | ||
| 38 | EUCTR2009-013223-37-HU (EUCTR) | 16/10/2009 | 02/09/2009 | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: PF-04171327 Product Code: PF-04171327 Product Name: PF-04171327 Product Code: PF-04171327 INN or Proposed INN: Prednisone Other descriptive name: Decortin® | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | Hungary;Spain | ||
| 39 | NCT00938587 (ClinicalTrials.gov) | October 2009 | 13/7/2009 | A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis | A Phase 2a, Randomized, Double-Blind, Active And Placebo-Controlled Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: PF-04171327 10 mg;Other: Prednisone Placebo;Drug: PF-04171327 25 mg;Drug: Prednisone 5 mg;Other: Placebo for PF-04171327;Other: Placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 86 | Phase 2 | United States;Czechia;Hong Kong;Hungary;Korea, Republic of;Russian Federation;Serbia;Singapore;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic |
| 40 | NCT01075711 (ClinicalTrials.gov) | April 2009 | 24/2/2010 | Determine the Improvement in Activity Status/Quality of Life (QoL) of Patients With Rheumatoid Arthritis (RA) During Treatment With Lodotra (Prednisone) | Non-interventional Study for Determining the Improvement in the Activity Status / Life Quality of Patients With Rheumatoid Arthritis Being Treated With the Tempus Tablet | Arthritis, Rheumatoid | Drug: Prednisone | Merck KGaA | Merck Serono GmbH, Germany | Completed | 18 Years | N/A | Both | 2728 | N/A | Germany |
| 41 | NCT01172639 (ClinicalTrials.gov) | February 2009 | 28/7/2010 | Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis. | A 2 Year Prospective Multicentre Randomised Controlled Trial Comparing Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Prednisone | P. Verschueren | Agentschap voor Innovatie door Wetenschap en Technologie | Completed | 18 Years | N/A | All | 400 | Phase 4 | Belgium |
| 42 | EUCTR2007-006150-25-DE (EUCTR) | 09/01/2009 | 26/05/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects with Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate - TRU-015 | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: Prednisone Trade Name: Solu-Medrone 125mg INN or Proposed INN: Methylprednisolone Sodium Succinate Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: Prednisone Trade Name: Solu-Medrone 125mg INN or Proposed INN: Methylprednisolone Sodium Succinate | Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | Hungary;Germany;Serbia;Netherlands;Belgium;Mexico;France;Romania;Austria | |||
| 43 | EUCTR2007-006150-25-AT (EUCTR) | 03/12/2008 | 07/10/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg INN or Proposed INN: METHYLPREDNISOLONE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg INN or Proposed INN: METHYLPREDNISOLONE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | Hungary;Germany;Netherlands;Belgium;France;Austria | |||
| 44 | EUCTR2007-006150-25-NL (EUCTR) | 01/12/2008 | 02/06/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | Hungary;Germany;Netherlands;Belgium;France;Austria | |||
| 45 | EUCTR2007-006150-25-BE (EUCTR) | 05/09/2008 | 24/06/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 2 | France;Hungary;Belgium;Austria;Netherlands;Germany | ||
| 46 | NCT00746512 (ClinicalTrials.gov) | September 2008 | 3/9/2008 | A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088) | A Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Access the Effects of Oral Prednisone on Clinical Efficacy and the Power Doppler Ultrasound Signal of Synovium in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisone 15 mg;Drug: Placebo Tablets;Drug: Prednisone 7.5 mg;Drug: Placebo Over-Encapsulated Tablets | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 45 | Phase 1 | United Kingdom |
| 47 | EUCTR2007-006150-25-HU (EUCTR) | 04/07/2008 | 01/04/2009 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects with Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate - TRU-015 | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: Prednisone Trade Name: Solu-Medrone 125mg INN or Proposed INN: Methylprednisolone Sodium Succinate | Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;Serbia;Hungary;Mexico;Belgium;Romania;Austria;Netherlands;Germany | |||
| 48 | EUCTR2007-003508-36-GB (EUCTR) | 02/07/2008 | 29/02/2008 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Lodotra® INN or Proposed INN: Prednisone | Nitec Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Germany;United Kingdom | ||
| 49 | EUCTR2007-006150-25-FR (EUCTR) | 24/06/2008 | 05/05/2008 | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: TRU-015 Trade Name: Decortin 5mg tablets INN or Proposed INN: PREDNISONE Trade Name: Solu-Medrone 125mg Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 2 | France;Hungary;Belgium;Austria;Netherlands;Germany | ||
| 50 | EUCTR2007-003508-36-HU (EUCTR) | 17/06/2008 | 18/02/2008 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Lodotra® INN or Proposed INN: Prednisone | Nitec Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Hungary;Germany;United Kingdom | |||
| 51 | EUCTR2007-003508-36-DE (EUCTR) | 25/04/2008 | 28/03/2008 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2 | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | INN or Proposed INN: Prednisone | Nitec Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 350 | Hungary;Germany;United Kingdom | |||
| 52 | NCT00650078 (ClinicalTrials.gov) | March 2008 | 28/3/2008 | Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis | A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MR prednisone;Drug: Placebo | Horizon Pharma Ireland, Ltd., Dublin Ireland | NULL | Completed | 18 Years | 80 Years | All | 350 | Phase 3 | United States;Canada;Germany;Hungary;Poland;United Kingdom |
| 53 | NCT00634933 (ClinicalTrials.gov) | March 2008 | 5/3/2008 | Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate | Arthritis, Rheumatoid | Drug: TRU-015;Drug: Methylprednisolone;Drug: Prednisone | Pfizer | Trubion Pharmaceuticals/Emergent BioSolutions Inc. | Terminated | 18 Years | N/A | All | 222 | Phase 2 | United States;Belgium;Canada;France;Germany;Hungary;Mexico;Netherlands;Romania;Serbia;Austria |
| 54 | NCT00580229 (ClinicalTrials.gov) | December 2007 | 18/12/2007 | A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis. | A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: prednisone | University of South Florida | NULL | Completed | 18 Years | 80 Years | All | 50 | Phase 2/Phase 3 | United States |
| 55 | EUCTR2007-002976-32-NL (EUCTR) | 06/09/2007 | 30/08/2007 | COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis. | COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis. | Patients with early rheumatoid arthritis wil be treated with a combination therapy: COBRA according to BEST or a modified COBRA schedule (COBRA-light). | Trade Name: Prednisone Trade Name: Methotrexate Trade Name: Sulphasalazine | TIPharma | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 56 | NCT00480272 (ClinicalTrials.gov) | May 2007 | 29/5/2007 | Prospective Study on Intensive Early Rheumatoid Arthritis Treatment | A Phase IV Multicenter, Randomized, Double-blind Study. prospeCtive Study on Intensive Early Rheumatoid Arthritis Treatment With adalimUmab: Induction of REmission and Maintenance | Rheumatoid Arthritis | Drug: adalimumab, plus prednisone;Drug: adalimumab plus placebo | IRCCS Policlinico S. Matteo | NULL | Completed | 18 Years | 70 Years | All | 251 | Phase 4 | Italy |
| 57 | EUCTR2006-006186-16-NL (EUCTR) | 30/01/2007 | 16/07/2007 | IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVED | IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVED | rheumatoid arthritis and undifferentiated arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Methotrexate Product Code: MTX INN or Proposed INN: METHOTREXATE Product Name: Prednisone INN or Proposed INN: PREDNISONE Product Name: Sulfasalazine INN or Proposed INN: SULFASALAZINE Trade Name: hydroxychloroquine Product Name: hydroxychloroquine Product Code: HCQ INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE Trade Name: Humira Product Name: adalimumab | Leiden University Medical Center, department of rheumatology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 58 | EUCTR2006-003843-22-IT (EUCTR) | 24/10/2006 | 30/08/2006 | prospeCtive study on intensive early rheumatoid arthritis treatment with adalimUmab: induction of REmission and maintenance - 'CURE'A Phase IV multicenter, randomized, double-blind study | prospeCtive study on intensive early rheumatoid arthritis treatment with adalimUmab: induction of REmission and maintenance - 'CURE'A Phase IV multicenter, randomized, double-blind study | rheumatoid arthritis MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T INN or Proposed INN: Adalimumab Trade Name: METHOTREXATE*100CPR 2,5MG INN or Proposed INN: Methotrexate Trade Name: DELTACORTENE FORTE*10CPR 25MG INN or Proposed INN: Prednisone | OSPEDALE POLICLINICO S. MATTEO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Italy | |||
| 59 | EUCTR2005-004385-16-GB (EUCTR) | 03/01/2006 | 08/12/2005 | CIRCADIAN VARIATIONS IN CYTOKINES AND THE EFFECT OF TIMED RELEASE TABLET PREDNISONE IN RHEUMATOID ARTHRITIS | CIRCADIAN VARIATIONS IN CYTOKINES AND THE EFFECT OF TIMED RELEASE TABLET PREDNISONE IN RHEUMATOID ARTHRITIS | Rheumatoid arthritis | Product Name: Prednisone INN or Proposed INN: Prednisone | United Bristol Healthcare NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 12 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): | United Kingdom | ||
| 60 | NCT00146640 (ClinicalTrials.gov) | August 31, 2004 | 6/9/2005 | Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis | A New Timed-Release Tablet Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis- A Randomized, Multi-Centre, Double-Blind, Active Controlled Study With Open Extension on the New Drug Only | Rheumatoid Arthritis | Drug: MR Prednisone;Drug: IR Prednisone;Drug: Placebo - MR Prednisone;Drug: Placebo - IR Prednisone | Merck KGaA, Darmstadt, Germany | NULL | Completed | 18 Years | 80 Years | All | 288 | Phase 3 | Germany;Poland |
| 61 | NCT00006055 (ClinicalTrials.gov) | March 2000 | 5/7/2000 | Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases | Purpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu Arteritis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation | Fairview University Medical Center | NULL | Active, not recruiting | 1 Year | 55 Years | Both | 10 | N/A | United States |
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 | NCT05666336 (ClinicalTrials.gov) | December 31, 2022 | 8/12/2022 | Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients | Proteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Telitacicept;Drug: Hydroxychloroquine;Drug: Prednisone;Drug: Methylprednisolone;Drug: Cyclophosphamide;Drug: Mycophenolate Mofetil;Drug: Tacrolimus | Fen Li | NULL | Not yet recruiting | 18 Years | 75 Years | All | 30 | Phase 4 | NULL |
| 2 | 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 |
| 3 | ChiCTR2100048635 | 2021-07-19 | 2021-07-12 | The Impact of low-dose prednisone withdrawal on disease flare and organ damage in SLE patients: a randomized clinical trial | The Impact of low-dose prednisone withdrawal on disease flare and organ damage in SLE patients: a randomized clinical trial | Systemic Lupus Erythematosus | Withdrawal group:withdraw low dose prednisone;maintanence group:maintain low dose prednisone; | Peking University First Hospital | NULL | Pending | Both | Withdrawal group:92;maintanence group:92; | China | |||
| 4 | ITMCTR1900002316 | 2019-06-20 | 2019-05-04 | Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin | Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin | Systemic Lupus Erythematosus | healthy control group:nothing;control group:Prednisone acetate tablets\Hydroxychloroquine;Experimental group:Langchuangjing granule + Prednisone acetate tablets, Hydroxychloroquine; | Nanjing University of Chinese Medicine Affiliated Hospital | NULL | Pending | Both | healthy control group:20;control group:20;Experimental group:20; | Phase 1 | China | ||
| 5 | ChiCTR1900022934 | 2019-06-20 | 2019-05-04 | Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin | Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin | Systemic Lupus Erythematosus | Experimental group:Langchuangjing granule + Prednisone acetate tablets, Hydroxychloroquine;control group:Prednisone acetate tablets?Hydroxychloroquine;healthy control group:nothing; | Nanjing University of Chinese Medicine Affiliated Hospital | NULL | Pending | Both | Experimental group:20;control group:20;healthy control group:20; | Phase 1 | China | ||
| 6 | NCT03804723 (ClinicalTrials.gov) | June 2019 | 11/1/2019 | Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus | Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial | Systemic Lupus Erythematosus;Glucocorticoids;Therapy Withdrawal | Drug: oral Prednisone 5mg | University of Pisa | NULL | Not yet recruiting | 18 Years | 85 Years | All | 321 | N/A | NULL |
| 7 | ChiCTR1800020286 | 2019-02-01 | 2018-12-22 | Clinical evaluation of the application of Langchuangjing granule in the treatment of systemic lupus erythematosus | Efficacy and safety of Langchuangjing granule in the treatment of systemic lupus erythematosus: a clinical evaluation | Systemic Lupus Erythematosus | Group 2:Langchuangjing granule + Prednisone acetate tablets, hydroxychloroquine and other Western medicines for 12 weeks.;Group 1:Prednisone acetate tablets, hydroxychloroquine and other Western medicines for 12 weeks.; | Nanjing University of Chinese Medicine Affiliated Hospital | NULL | Pending | Both | Group 2:40;Group 1:20; | I (Phase 1 study) | China | ||
| 8 | ChiCTR1800017540 | 2018-09-01 | 2018-08-03 | A randomized controlled trial for the long-term outcomes of MMF on new onset SLE patients with high titers of anti-dsDNA antibody for reducing main organ involvement | A randomized controlled trial for the long-term outcomes of MMF on new onset SLE patients with high titers of anti-dsDNA antibody for reducing main organ involvement | systemic lupus erythematosus | 1:Hydroxychloroquine (5mg/kg/day) plus prednisone (0.5mg/kg/day);2:Hydroxychloroquine (5mg/kg/day) plus prednisone (0.5mg/kg/day) plus Mycophenolate Mofetil 500mg bid; | Ruijin Hospital | NULL | Completed | 18 | 65 | Both | 1:65;2:65; | Phase 4 | China |
| 9 | NCT03492255 (ClinicalTrials.gov) | April 12, 2018 | 16/3/2018 | CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid | CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid | Systemic Lupus Erythematosus (SLE) | Drug: Cyclophosphamide;Drug: Methylprednisolone;Drug: Prednisone;Drug: Mycophenolate Mofetil | University of Sao Paulo General Hospital | Fundação de Amparo à Pesquisa do Estado de São Paulo | Terminated | 18 Years | N/A | All | 49 | N/A | Brazil |
| 10 | NCT03098823 (ClinicalTrials.gov) | September 12, 2017 | 21/3/2017 | A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE | A Randomized, Double-Blind, Active Comparator-Controlled, Crossover Study to Assess the Capacity of RAYOS® Compared to Immediate-Release Prednisone to Improve Fatigue and Control Morning Symptoms in Subjects With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic;Lupus Erythematosus;Fatigue | Drug: RAYOS;Drug: Prednisone | Ampel BioSolutions, LLC | NULL | Completed | 18 Years | 99 Years | All | 62 | Phase 4 | United States |
| 11 | ChiCTR-INR-17011495 | 2017-05-25 | 2017-05-26 | Canceled by the investigator The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic sy | The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic systemic lupus erythematosus | Primary mild to moderate systemic systemic lupus erythematosus | Immunomodulatory treatment group:The level of SELSNA-SLEDAI was evaluated at week 4, week 12 and week 24, the BILAG table, the SLE lesion index, and the SLE damage index were measured at 4 weeks, 12 weeks and 24 weeks. The levels of Th17, Treg and Th17 / Treg were measured.;Leflunomide treatment group:Leflunomide tablets 10m, 1 times / day, orally. The SELSNA-SLEDAI score table, BILAG worksheet, SLE damage index score were assessed at week 4, week 12 and week 24, and serum Th17, Treg and Th17 / Treg ratios were measured.;Immunomodulatory treatment group and Leflunomide treatment group :0 weeks to give prednisone acetate tablets 0.5-1mg / kg.d (or patients can choose to take the same dose of methylprednisolone tablets), 4 weeks after the beginning of the dose by 2 weeks to reduce the regular dose of 10% Reduction to prednisone acetate tablets 10mg / day to maintain.;Immunomodulatory treatment group and Leflunomide treatment group:All patients without contraindications plus hydroxychloroquine tablets 0.2,2 / day, orally; and according to the condition plus calcium (800-1200mg / day), vitamin D (200-800IU / day) and other treatment.; | The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology | NULL | Recruiting | Both | Immunomodulatory treatment group:15;Leflunomide treatment group:15;Immunomodulatory treatment group and Leflunomide treatment group :30;Immunomodulatory treatment group and Leflunomide treatment group:30; | China | |||
| 12 | NCT02558517 (ClinicalTrials.gov) | January 2014 | 22/9/2015 | Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus | Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic Lupus | Systemic Lupus Erythematosus | Drug: prednisone discontinuation | Groupe Hospitalier Pitie-Salpetriere | NULL | Recruiting | 18 Years | 75 Years | Both | 136 | Phase 3 | France |
| 13 | NCT01946880 (ClinicalTrials.gov) | November 20, 2013 | 13/9/2013 | Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE) | An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients With Stable, Quiescent Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus;SLE | Drug: Mycophenolate Mofetil;Drug: Hydroxychloroquine or Chloroquine;Drug: Prednisone | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Terminated | 18 Years | 70 Years | All | 102 | Phase 2 | United States |
| 14 | EUCTR2009-017273-38-ES (EUCTR) | 26/10/2010 | 27/07/2010 | Estudio fase III, multicéntrico, aleatorizado, abierto de grupos paralelos para comparar la eficacia y seguridad de la pauta Prednisona-Ac Micofenólico-Ciclosporina a Prednisona-Ac Micofenólico en el tratamiento de las nefropatias lúpicas tipo III-IV-V | Estudio fase III, multicéntrico, aleatorizado, abierto de grupos paralelos para comparar la eficacia y seguridad de la pauta Prednisona-Ac Micofenólico-Ciclosporina a Prednisona-Ac Micofenólico en el tratamiento de las nefropatias lúpicas tipo III-IV-V | Nefritis lúpico tipo III,IV y V. MedDRA version: 9;Level: LLT;Classification code 10029142;Term: Nephritis systemic lupus erythematosus | Product Name: Ciclosporina Product Code: Csa INN or Proposed INN: CICLOSPORINA Other descriptive name: CICLOSPORIN INN or Proposed INN: PREDNISONA Other descriptive name: PREDNISONE Product Name: Acido Micofenolico Product Code: ACM INN or Proposed INN: MICOFENOLICO ACIDO Other descriptive name: MYCOPHENOLIC ACID | Manuel Praga Terente | NULL | Not Recruiting | Female: yes Male: yes | 38 | Spain | |||
| 15 | NCT01085097 (ClinicalTrials.gov) | September 1, 2010 | 4/3/2010 | A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids) | Lupus Nephritis | Drug: Laquinimod;Drug: Mycophenolate Mofetil;Drug: Prednisolone/Prednisone;Drug: Placebo;Drug: Methylprednisolone | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | 75 Years | All | 46 | Phase 2 | United States;Canada;France;Russian Federation;United Kingdom |
| 16 | ChiCTR-TRC-12001935 | 2008-01-12 | 2012-02-12 | Effect of Detoxification, Removing Stasis and Nourishing Kidney Method on Promoting the Reduction of Prednisone in Treating SLE | Effect of Detoxification, Removing Stasis and Nourishing Kidney Method on Promoting the Reduction of Prednisone in Treating SLE | mild-to-moderate systemic lupus erythematosus | Treatment Group:treated with prednisone and Jieduquyuzishen recipe;control group:treated with prednisone; | Zhejinag University of Chinese Medicine | NULL | Completed | 18 | 60 | Both | Treatment Group:161;control group:161; | 3 (Phase 3 study) | China |
| 17 | NCT00539838 (ClinicalTrials.gov) | December 19, 2007 | 3/10/2007 | A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN) | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Prednisone;Drug: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate);Drug: Methylprednisolone;Drug: Ocrelizumab;Drug: Placebo | Genentech, Inc. | Roche Pharma AG | Terminated | 16 Years | N/A | All | 33 | Phase 3 | United States |
| 18 | NCT00430677 (ClinicalTrials.gov) | June 2007 | 1/2/2007 | Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis | A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Corticosteroids (prednisone or prednisolone);Drug: Abatacept;Drug: Mycophenolate mofetil (MMF) | Bristol-Myers Squibb | NULL | Terminated | 18 Years | N/A | All | 423 | Phase 2/Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;China;France;Hong Kong;India;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Taiwan;Turkey;United Kingdom;Japan;Philippines;Puerto Rico |
| 19 | EUCTR2006-002107-13-IT (EUCTR) | 24/11/2006 | 09/03/2007 | A randomized, multicenter, open-label, 6-month study to explore the efficacy and safety of enteric-coated mycophenolate sodium myfortic in combination with two corticosteroid regimens for the treatment of lupus nephritis flare - ND | A randomized, multicenter, open-label, 6-month study to explore the efficacy and safety of enteric-coated mycophenolate sodium myfortic in combination with two corticosteroid regimens for the treatment of lupus nephritis flare - ND | Systemic lupus erythematosis MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Trade Name: MYFORTIC*50CPR RIV 360MG INN or Proposed INN: Mycophenolic acid Trade Name: DELTACORTENE*20CPR 5MG INN or Proposed INN: Prednisone Trade Name: MYFORTIC*50CPR RIV 360MG INN or Proposed INN: Mycophenolic acid Trade Name: DELTACORTENE*20CPR 5MG INN or Proposed INN: Prednisone | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;United Kingdom;France;Spain;Italy;Greece | |||
| 20 | NCT00336414 (ClinicalTrials.gov) | June 2006 | 12/6/2006 | Five-Year Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis | Five-Year Single-Blind, Phase III Effectiveness Randomised Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis: Oral Cyclophosphamide Versus High Dose Intravenous Cyclophosphamide Versus Intermediate Dose Intravenous Cyclophosphamide | Systemic Lupus Erythematosus Nephritis | Drug: cyclophosphamide-prednisone-azathioprine | Istituto Giannina Gaslini | NULL | Withdrawn | 1 Year | 18 Years | All | 0 | Phase 3 | Italy |
| 21 | EUCTR2005-003957-28-IT (EUCTR) | 02/05/2006 | 09/05/2006 | FIVE-YEAR SINGLE-BLIND, PHASE II EFFECTIVENESS RANDOMISED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE SYSTEMIC LUPUS ERYTHEMATOSUS NEPHTRITIS ORAL CYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUS CYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUS CYCLOPHOSPHAMIDE. - ND | FIVE-YEAR SINGLE-BLIND, PHASE II EFFECTIVENESS RANDOMISED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE SYSTEMIC LUPUS ERYTHEMATOSUS NEPHTRITIS ORAL CYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUS CYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUS CYCLOPHOSPHAMIDE. - ND | New onset juvenile sistemic lupus erythematosus nephritis MedDRA version: 6.1;Level: PT;Classification code 10025140 | INN or Proposed INN: Azathioprine INN or Proposed INN: Methylprednisolone INN or Proposed INN: Prednisone INN or Proposed INN: Cyclophosphamide INN or Proposed INN: Cyclophosphamide | ISTITUTO GIANNINA GASLINI | NULL | Not Recruiting | Female: yes Male: yes | 141 | Phase 3 | Belgium;Denmark;Italy | ||
| 22 | NCT00119678 (ClinicalTrials.gov) | September 2005 | 30/6/2005 | Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares | Systemic Lupus Erythematosus | Drug: Abatacept;Drug: Placebo;Drug: Prednisone | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 183 | Phase 2 | United States;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Italy;Korea, Republic of;Mexico;Puerto Rico;South Africa;Taiwan;United Kingdom;Sweden |
| 23 | NCT00137969 (ClinicalTrials.gov) | May 10, 2005 | 26/8/2005 | A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus | Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Rituximab;Drug: Placebo;Drug: Prednisone;Drug: Acetaminophen;Drug: Diphenhydramine | Genentech, Inc. | NULL | Completed | 16 Years | 75 Years | All | 262 | Phase 2/Phase 3 | United States;Canada |
| 24 | NCT00006055 (ClinicalTrials.gov) | March 2000 | 5/7/2000 | Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases | Purpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu Arteritis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation | Fairview University Medical Center | NULL | Active, not recruiting | 1 Year | 55 Years | Both | 10 | N/A | United States | |
| 25 | NCT00000421 (ClinicalTrials.gov) | September 1997 | 3/11/1999 | Serologically Active, Clinically Stable Systemic Lupus Erythematosus | Serologically Active, Clinically Stable Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Prednisone;Drug: Placebo | New York University School of Medicine | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | 13 Years | 65 Years | Female | 154 | Phase 2 | United States |
| 26 | NCT00001212 (ClinicalTrials.gov) | November 1986 | 3/11/1999 | Drug Therapy in Lupus Nephropathy | Immunosuppressive Drug Therapy in Membranous Lupus Nephropathy | Nephrotic Syndrome;Systemic Lupus Erythematosus | Drug: prednisone;Drug: cyclophosphamide;Drug: cyclosporin A | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | N/A | N/A | Both | 45 | Phase 2 | United States |
| 27 | EUCTR2017-002050-36-FR (EUCTR) | 03/11/2017 | Personalised approach to the tapering of corticosteroid treatment in systemic lupus patients | Personalised pharmacological approach to the tapering of corticosteroid doses in systemic lupus patients treated with prednisone - DECOR | Systemic lupus erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: Prednisone | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | NA | Female: yes Male: yes | 120 | Phase 4 | France |
50. 皮膚筋炎／多発性筋炎
臨床試験数 : 194 / 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
| 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 | ChiCTR-TRC-13003178 | 2013-05-01 | 2013-01-03 | Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study | Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study | Polymyositis/Dermatomyositis | group1-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg / d, then reduce 2.5mg every two weeks to 5mg/d, maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;group1-predinsone+MTX group:MTX 10-20mgQw×24w; MTX 7.5-10mgQw×48w, the usage of prednisone is the same as in the control group.;group1-predinsone+LEF group:LEF 20mg/d×24w; LEF 10mg/d×48w, the usage of prednisone is the same as in the control group.;group2-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg/d, then reduce 2.5mg every two weeks to 5mg/d,maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;group2-predinsone+CTX group:CTX iv 0.8-1.0g/4w×24w; CTX iv 0.8-1.0g/12w×48w, the usage of prednisone is the same as in the control group.;group2-predinsone+MTX group:MMF 1.5-2.0g /d×24w; MMF 0.75-1g/d×48w, the usage of prednisone is the same as in the control group.; | Department of rheumatology, China-Japan Friendship hospital | NULL | Recruiting | 18 | 70 | Both | group1-predinsone group(control group):94;group1-predinsone+MTX group:94;group1-predinsone+LEF group:94;group2-predinsone group(control group):94;group2-predinsone+CTX group:94;group2-predinsone+MTX group:94; | China | |
| 2 | EUCTR2005-003956-37-GB (EUCTR) | 18/06/2008 | 20/03/2008 | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisolone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisolone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Juvenile Dermatomyositis at onset | Trade Name: treatment defined only by active substance Product Name: prednisone Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methylprednisolone Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methotrexate Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methotrexate Product Code: not available INN or Proposed INN: not availa | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 3 | NCT00651040 (ClinicalTrials.gov) | May 2008 | 31/3/2008 | Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM | A Prospective, Randomised, Assessor-blind, Multicenter Study of Efficacy and Safety of Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With Polymyositis and Dermatomyositis. | Polymyositis;Dermatomyositis | Drug: Prednisone;Drug: Methotrexate | Institute of Rheumatology, Prague | Karolinska Institutet | Completed | 18 Years | 80 Years | All | 31 | Phase 3 | Czech Republic |
| 4 | EUCTR2005-003956-37-SE (EUCTR) | 23/02/2007 | 11/12/2006 | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Juvenile Dermatomyositis at onset | Trade Name: treatment defined only by active substance Product Name: Prednisone Product Code: Not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methylprednisolone Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: Cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: not available Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: Cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: Methotrexate Product Code: not available | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 5 | EUCTR2005-003956-37-BE (EUCTR) | 13/11/2006 | 25/10/2006 | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate - PRINTO JDM Trial | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate - PRINTO JDM Trial | Juvenile Dermatomyositis at onset | Product Name: Prednisolone INN or Proposed INN: Methylprednisolone Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolone sodium succinate Product Name: Cyclosporine INN or Proposed INN: Cyclosporine A Product Name: Cyclosporine INN or Proposed INN: Cyclosporine A Product Name: Methotrexate INN or Proposed INN: Methotrexate Product Name: Methotrexate INN or Proposed INN: Methotrexate | University Hospital Gent | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 6 | EUCTR2005-003956-37-DK (EUCTR) | 03/11/2006 | 15/09/2006 | Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Juvenile Dermatomyositis at onset | Product Name: Prednisone Product Name: methylprednisolone Product Name: Cyclosporine Product Name: Cyclosporine Product Name: Cyclosporine Product Name: Metotrexate Product Name: Methotrexate | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | Belgium;Denmark;Netherlands;United Kingdom;Italy;Sweden | ||
| 7 | EUCTR2005-003956-37-NL (EUCTR) | 26/09/2006 | 01/06/2006 | Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis:prednisone versus prednisone plus cyclosporine A versus prednisone plus mehotrexate | Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis:prednisone versus prednisone plus cyclosporine A versus prednisone plus mehotrexate | Juvenile Dermatomyositis at onset | INN or Proposed INN: Prednisone INN or Proposed INN: Methylprednisolone INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Methotrexate INN or Proposed INN: Methotrexate | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 8 | EUCTR2005-003956-37-IT (EUCTR) | 02/05/2006 | 12/09/2006 | FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMIZED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE DERMATOMYOSITIS PREDNISONE VERSUS PREDNISONE PLUS CYCLOSPORINE A VERSUS PREDNISONE PLUS METHOTREXATE - ND | FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMIZED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE DERMATOMYOSITIS PREDNISONE VERSUS PREDNISONE PLUS CYCLOSPORINE A VERSUS PREDNISONE PLUS METHOTREXATE - ND | New Onset juvenile dermatomyositis MedDRA version: 6.1;Level: PT;Classification code 10012503 | INN or Proposed INN: Prednisone INN or Proposed INN: Methylprednisolone INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Methotrexate INN or Proposed INN: Methotrexate | ISTITUTO GIANNINA GASLINI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 9 | NCT00323960 (ClinicalTrials.gov) | May 2006 | 9/5/2006 | Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis | Five-year Single-blind, Phase III Effectiveness Randomised Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis: Prednisone Versus Prednisone Plus Cyclosporine a Versus Prednisone Plus Methotrexate | Juvenile Dermatomyositis | Drug: 3 MPDN pulse + PDN;Drug: 3 MPDN pulse + PDN + CSA;Drug: 3 MPDN pulse + PDN + MTX | Istituto Giannina Gaslini | Pediatric Rheumatology International Trials Organization | Recruiting | 1 Year | 18 Years | Both | 120 | Phase 3 | Italy |
| 10 | NCT00035958 (ClinicalTrials.gov) | August 2002 | 7/5/2002 | Understanding the Pathogenesis and Treatment of Childhood Onset Dermatomyositis | Toward Improved Understanding of Pathogenesis and Treatment of Childhood Onset Dermatomyositis | Dermatomyositis | Drug: Prednisone;Drug: Methotrexate;Drug: Etanercept | Children's Hospital Medical Center, Cincinnati | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Immunex Corporation | Terminated | 4 Years | 16 Years | Both | 75 | Phase 2/Phase 3 | United States |
51. 全身性強皮症
臨床試験数 : 525 / 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
| 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 | NCT01086540 (ClinicalTrials.gov) | June 24, 2011 | 11/3/2010 | Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | Systemic Sclerosis-Associated PAH | Biological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophen | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Completed | 18 Years | 75 Years | All | 57 | Phase 2 | United States |
53. シェーグレン症候群
臨床試験数 : 305 / 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188
| 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 | ChiCTR1900024642 | 2019-08-01 | 2019-07-19 | Clinical Study of Iguratimod in the Treatment of Primary Sjogren's Syndrome | Clinical Study of Iguratimod in the Treatment of Primary Sjogren's Syndrome | Primary Sjogren's Syndrome | Experimental group:Iguratimod+Prednisone;control group:HCQ+Prednisone; | Chongqing Hospital of Traditional Chinese Medcine | NULL | Recruiting | 18 | 65 | Both | Experimental group:30;control group:30; | N/A | China |
| 2 | ITMCTR1900002482 | 2019-08-01 | 2019-07-19 | Clinical Study of Iguratimod in the Treatment of Primary Sjogren's Syndrome | Clinical Study of Iguratimod in the Treatment of Primary Sjogren's Syndrome | Primary Sjogren's Syndrome | Experimental group:Iguratimod+Prednisone;control group:HCQ+Prednisone; | Chongqing Hospital of Traditional Chinese Medcine | NULL | Recruiting | 18 | 65 | Both | Experimental group:30;control group:30; | N/A | China |
| 3 | ChiCTR-INR-16009629 | 2017-04-01 | 2016-10-26 | A double blinded Stratified sampling study of Jiedu Tongluo Shengjin prescription in treatment of primary Sjogren syndrome | A double blinded Stratified sampling study of Jiedu Tongluo Shengjin prescription in treatment of primary Sjogren syndrome | primary Sjogren's Syndrome | low disease activity-experimental group:Jiedu Tongluo Shengjin prescription;low disease activity-control group:Jiedu Tongluo Shengjin prescription placebo;moderate disease activity-experimental group:Jiedu Tongluo Shengjin prescription;moderate disease activity-experimental group:prednisone 10mg/d;moderate disease activity-experimental group:Hydorxychloroquine 0.2g/d;moderate disease activity-control group:Jiedu Tongluo Shengjin prescription placebo;moderate disease activity-control group:prednisone 10mg/d;moderate disease activity-control group:Hydorxychloroquine 0.2g/d; | Yueyang Hospital of Integrated Medicine affiliated to Shanghai University of Tradition Chinese Medicine | NULL | Pending | 18 | 70 | Both | low disease activity-experimental group:27;low disease activity-control group:27;moderate disease activity-experimental group:27;moderate disease activity-experimental group:27;moderate disease activity-experimental group:27;moderate disease activity-con | China | |
| 4 | NCT02370550 (ClinicalTrials.gov) | March 2015 | 18/2/2015 | Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome | Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial | Sjogren's Syndrome | Drug: Cyclosporin A;Drug: Prednisone;Drug: Placebo;Drug: Calcium carbonate D | Peking University People's Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 240 | Phase 4 | China |
61. 自己免疫性溶血性貧血
臨床試験数 : 146 / 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
| 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 | NCT01579110 (ClinicalTrials.gov) | April 2012 | 13/4/2012 | Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia. | Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia. | Anemia;Anemia, Hemolytic;Anemia, Hemolytic, Autoimmune;Hemolysis;Hematologic Diseases;Autoimmune Diseases;Immune System Diseases;Pathologic Processes | Drug: levamisole;Drug: Prednisone | Institute of Hematology & Blood Diseases Hospital | NULL | Active, not recruiting | 18 Years | N/A | Both | 100 | Phase 2 | China |
| 2 | NCT01345708 (ClinicalTrials.gov) | January 2009 | 28/4/2011 | A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia | A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia | Autoimmune Hemolytic Disease (Cold Type) (Warm Type) | Drug: prednisone, low dose rituximab | Fondazione Ospedale | University Hospital, Udine, Italy | Completed | 18 Years | N/A | Both | 23 | Phase 2 | Italy |
| 3 | EUCTR2008-006713-25-IT (EUCTR) | 23/09/2008 | 16/01/2009 | A SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - ND | A SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - ND | ANEMIE EMOLITICHE AUTOIMMUNI IDIOPATICHE | INN or Proposed INN: Rituximab | OSPEDALE MAGGIORE DI MILANO (IRCCS) | NULL | Not Recruiting | Female: yes Male: yes | Italy |
63. 特発性血小板減少性紫斑病
臨床試験数 : 391 / 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
| 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 | ChiCTR2100053604 | 2022-01-01 | 2021-11-24 | A clinical study of the efficacy of low-dose prednisone maintenance therapy on adult patients with relapsed chronic/persistent primary immune thrombocytopenia | A clinical study of the efficacy of low-dose prednisone maintenance therapy on adult patients with relapsed chronic/persistent primary immune thrombocytopenia | Primary immune thrombocytopenia | Experimental group:High-dose dexamethasone followed by low-dose prednisone maintenance treatment;Control group:Placebo-controlled after high-dose dexamethasone treatment; | The Second Affiliated Hospital of Guangxi Medical University | NULL | Recruiting | 18 | 60 | Both | Experimental group:113;Control group:113; | Phase 4 | China |
| 2 | ChiCTR2100053452 | 2022-01-01 | 2021-11-21 | A prospective, multicenter, randomized controlled study of different doses of prednisone in the treatment of children with primary immune thrombocytopenia | A prospective, multicenter, randomized controlled study of different doses of prednisone in the treatment of children with primary immune thrombocytopenia | Children Primary immune thrombocytopenia | experimental group:Prednisone 1.5-2.0mg/kg/d, divided into 2-3 times, the platelet count is stable for 1-2 weeks, and the dose is gradually reduced to withdrawal, and the course of treatment is 4-6 weeks;control group:Prednisone 3-4.0mg/kg/d for 4-7 days; | Huizhou Municipal Central Hospital | NULL | Recruiting | 0 | 18 | Both | experimental group:28;control group:28; | Phase 4 | China |
| 3 | ChiCTR1900027735 | 2020-01-01 | 2019-11-24 | Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP) | Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP) | Adult newly diagnosed immune thrombocytopenia | Study group:Dexamethasone 40mg/d×4d, recombinant human thrombopoietin (rhTPO) 300U/Kg subcutaneous injection, once/d×14d, if PLT>100×109/L or PLT increase =50×109/L during treatment period RhTPO drug was discontinued; rhTPO and dexamethasone were replaced with prednisone 0.5mg~1mg/kg once a day, 0.2mg/kg per week, and the drug was stopped wit;Control group:Dexamethasone 40mg/d×4d, if the PLT>100×10^9/L or PLT increase =50×10^9/L during the treatment period, dexamethasone was replaced with prednisone 0.5mg~ 1mg/kg orally every day, reduce 0.2mg/kg per week, and quickly reduce the dose within 6~8 weeks.; | Department of Hematology, Anhui Provincial Hospital | NULL | Pending | 18 | 80 | Both | Study group:30;Control group:30; | Phase 4 | China |
| 4 | NCT02914054 (ClinicalTrials.gov) | October 1, 2016 | 19/9/2016 | Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With Dexamethasone | Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With 3 Cycles Pulses of High-dose Dexamethasone (HD-DXM) | ITP;Croticosteroid Therapy | Drug: High dose Dexamethasone pulses;Drug: Prednisone | Isfahan University of Medical Sciences | Adibvira | Completed | 18 Years | N/A | All | 36 | Phase 2/Phase 3 | Iran, Islamic Republic of |
| 5 | NCT01356511 (ClinicalTrials.gov) | September 2010 | 17/5/2011 | High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP) | High-dose Dexamethasone and Conventional Dose Prednisone, for the First-line Treatment of Adults With ITP: a Multicenter, Randomized Controlled, Clinical Trial | Purpura, Thrombocytopenic, Idiopathic | Drug: Prednisone;Drug: Dexamethasone | Shandong University | Chinese Academy of Medical Sciences;Peking Union Medical College Hospital;Ruijin Hospital;Wuhan Union Hospital, China;Tongji Hospital;Shandong University of Traditional Chinese Medicine;Anhui Provincial Hospital;Zhejiang Provincial Hospital of TCM;Second Hospital of Shanxi Medical University;Xinjiang Uygur Autonomous Region People's Hospital;Shenzhen Second People's Hospital | Completed | 18 Years | 80 Years | Both | 261 | Phase 4 | China |
| 6 | EUCTR2008-000417-30-IT (EUCTR) | 19/06/2008 | 11/04/2008 | Randomized study for the treatment of primary Immune Thrombocytopenic Purpura (ITP) in newly diagnosed untreated adult patients. Comparison of standard dose prednisone versus high-dose Dexamethasone. GIMEMA Protocol ITP0207 - GIMEMA ITP0207 | Randomized study for the treatment of primary Immune Thrombocytopenic Purpura (ITP) in newly diagnosed untreated adult patients. Comparison of standard dose prednisone versus high-dose Dexamethasone. GIMEMA Protocol ITP0207 - GIMEMA ITP0207 | ITP Primary Immune Thrombocytopenic Purpura in newly diagnosed untreated adult patients MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Dexamethasone INN or Proposed INN: Dexamethasone Product Name: Prednisone INN or Proposed INN: Prednisone | G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 7 | NCT00161564 (ClinicalTrials.gov) | February 2004 | 8/9/2005 | A Trial to Treat Patients With ITP Who Do Not Achieve a Durable Response to Rituxan Alone | A Randomized Trial Comparing Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine,and Prednisone) in Subjects With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment | Idiopathic Thrombocytopenic Purpura (ITP) | Drug: Rituximab | Weill Medical College of Cornell University | Genentech, Inc. | Withdrawn | 12 Years | N/A | All | 0 | Phase 2 | United States |
64. 血栓性血小板減少性紫斑病
臨床試験数 : 92 / 薬物数 : 85 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 76
| 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 | NCT00713193 (ClinicalTrials.gov) | November 2007 | 9/7/2008 | Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in Thrombotic Thrombocytopenic Purpura (TTP) | A Multi-Center, Randomized Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in the Initial Therapy of Thrombotic Thrombocytopenic Purpura (TTP) | Thrombotic Thrombocytopenic Purpura | Drug: Cyclosporine;Drug: Prednisone | Ohio State University | Food and Drug Administration (FDA) | Completed | 18 Years | N/A | All | 16 | Phase 3 | United States |
65. 原発性免疫不全症候群
臨床試験数 : 500 / 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
| 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 | NCT00187057 (ClinicalTrials.gov) | September 2002 | 12/9/2005 | Study for Treatment of Cancer in Children With Ataxia-telangiectasia | Pilot Study I for Treatment of Cancer in Children With Ataxia-Telangiectasia | Ataxia-Telangiectasia | Drug: vinblastine, vincristine, prednisone, daunorubicin;Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase;Drug: etoposide, cytarabine, mercaptopurine;Drug: dexamethasone, procarbazine;Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy | St. Jude Children's Research Hospital | Children's Hospital of Philadelphia;National Cancer Institute (NCI) | Completed | N/A | 10 Years | Both | 6 | N/A | United States |
| 2 | NCT00006054 (ClinicalTrials.gov) | March 2000 | 5/7/2000 | Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies | Immunologic Deficiency Syndromes;Chediak-Higashi Syndrome;Common Variable Immunodeficiency;Graft Versus Host Disease;X-Linked Lymphoproliferative Syndrome;Familial Erythrophagocytic Lymphohistiocytosis;Hemophagocytic Lymphohistiocytosis;X-linked Agammaglobulinemia;Wiskott-Aldrich Syndrome;Chronic Granulomatous Disease;X-linked Hyper IgM Syndrome;Severe Combined Immunodeficiency;Leukocyte Adhesion Deficiency Syndrome;Virus-Associated Hemophagocytic Syndrome | Drug: anti-thymocyte globulin;Drug: busulfan;Drug: cyclophosphamide;Drug: cyclosporine;Drug: etoposide;Drug: methotrexate;Drug: methylprednisolone;Drug: prednisone;Procedure: Allogeneic Bone Marrow Transplantation | Fairview University Medical Center | NULL | Terminated | N/A | 35 Years | Both | N/A | United States |
66. IgA腎症
臨床試験数 : 275 / 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
| 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 | NCT04020328 (ClinicalTrials.gov) | September 12, 2019 | 10/7/2019 | Leflunomide Plus Low Dose Corticosteroid in Immunoglobulin A (IgA) Nephropathy With Renal Insufficiency | A Randomized, Controlled Trial to Evaluate Leflunomide Plus Low Dose Corticosteroid Therapy in Progressive IgA Nephropathy With Renal Insufficiency | Glomerulonephritis, IGA;Renal Insufficiency, Chronic | Drug: Leflunomide 20 mg+prednisone 0.5mg/kg/d | Shenzhen Second People's Hospital | NULL | Recruiting | 14 Years | 65 Years | All | 70 | Phase 4 | China |
| 2 | EUCTR2016-004507-31-FR (EUCTR) | 27/01/2017 | 02/02/2017 | N/A | N/A - TIGER | MedDRA version: 19.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders | Trade Name: METHYLPREDNISOLONE MYLAN Générique Product Name: METHYLPREDNISOLONE MYLAN Générique INN or Proposed INN: Methylprednisolone Other descriptive name: Methylprednisolone Trade Name: PREDNISONE ARROW 20mg Product Name: PREDNISONE ARROW 20mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: PREDNISONE ARROW 5 mg Product Name: PREDNISONE ARROW 5 mg INN or Proposed INN: Prednisone 5 mg Other descriptive name: Prednisone 5 mg | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 122 | Phase 3 | France | ||
| 3 | NCT03218852 (ClinicalTrials.gov) | December 2016 | 7/12/2016 | Extended Follow-up of Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy | An Extended Follow-up of the Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced Stage IgA Nephropathy | IgA Nephropathy | Drug: prednisone and cyclophosphamide;Drug: prednisone alone | Guangdong General Hospital | NULL | Active, not recruiting | 18 Years | 70 Years | All | 133 | Phase 4 | China |
| 4 | NCT02712697 (ClinicalTrials.gov) | June 2016 | 17/11/2015 | Integrative Medicine of IgA Nephropathy | Treatment of Shentong Granules Plus Prednisone on Patients With Severe IgA Nephropathy(Ying-deficiency of the Liver and Kidney Pattern): a Randomized, Double-blind,Placebo-controlled Multicentre Clinical Trial | Primary IgA Nephropathy | Drug: WM (Shentong Granules);Drug: Hormone (prednisone) | Shanghai University of Traditional Chinese Medicine | RenJi Hospital;Ruijin Hospital;Shanghai 6th People's Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Fudan University | Not yet recruiting | 18 Years | 70 Years | Both | 140 | N/A | China |
| 5 | NCT01758120 (ClinicalTrials.gov) | December 2012 | 12/12/2012 | Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy | A Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy | IgA Nephropathy | Drug: prednisone plus cyclophosphamide;Drug: Prednisone alone | Guangdong General Hospital | NULL | Active, not recruiting | 18 Years | 70 Years | All | 135 | Phase 4 | China |
| 6 | NCT01451710 (ClinicalTrials.gov) | March 2011 | 7/10/2011 | The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy | The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy | IgA Nephropathy | Drug: Prednisone or Prednisolone | Nanjing University School of Medicine | NULL | Completed | 18 Years | 65 Years | Both | 30 | N/A | China |
| 7 | ChiCTR-OPN-16010028 | 2011-01-01 | 2016-11-23 | Effects of Tripterygium wilfordii induction therapy to IgA nephropathy patients with heavy proteinuria | Effects of Tripterygium wilfordii induction therapy to IgA nephropathy patients with heavy proteinuria | IgA nephropathy | Prednisone (PRE) group:1mg/kg prednisone once daily;conventional-dose TW (CTW) group:60 mg TW daily;double-dose TW (DTW) group:?????120mg; | Yancheng Third People's Hospital | NULL | Completed | 21 | 54 | Both | Prednisone (PRE) group:10;conventional-dose TW (CTW) group:10;double-dose TW (DTW) group:10; | NULL | |
| 8 | NCT01269021 (ClinicalTrials.gov) | November 2010 | 10/12/2010 | An Multi-site Prospective Study to Assess the Efficacy and Safety of MMF in the Treatment of Proliferative IgA Nephropathy(IgAN) | Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China. | IgA Nephropathy (IgAN) | Drug: mycophenolate mofetil plus lower dose of Prednisone;Drug: Prednisone in full dose | Zhi-Hong Liu, M.D. | NULL | Completed | 18 Years | 60 Years | Both | 176 | N/A | China |
| 9 | ChiCTR-TRC-10000824 | 2010-01-01 | 2010-04-06 | the clinical effect of Fufang Shenyan Tablet on IgA Nephropathy patients | Multicenter, randomized, double-blind, placebo-controlled clinical research of the clinical effect of Fufang Shenyan Tablet on IgA Nephropathy patients | IgA Nephropathy | the control group:The 24-hour urinary protein 0.5-2.0g: Lotensin 10mg, bid; placebos 2.5g tid; The 24-hour urinary protein 2.0-3.5g: on this basis, combined with prednisone 40mg/d; If patients with hypertension(target blood pressure <=130/80mmHg), used Lotensin 10mg bid alone control it difficultly, give Norvasc 5mg, qd~bid instead; if still poorly controlled, combined with Betaloc 12.5mg, bid;the treatment group:The 24-hour urinary protein 0.5-2.0g: Lotensin 10mg, bid; Fufang Shenyan Tablets 2.5g tid; The 24-hour urinary protein 2.0-3.5g: on this basis, combined with prednisone 40mg/d; If patients with hypertension (target blood pressure <=130/80mmHg), used Lotensin 10mg bid alone control it difficultly, give Norvasc 5mg, qd~bid instead; if still poorly controlled, combined with Betaloc 12.5mg, bid; | The First Affiliated Hospital of Xi'an Jiaotong University Medical College | NULL | Completed | 18 | 65 | Both | the control group:60;the treatment group:60; | China | |
| 10 | ChiCTR-TRC-13003702 | 2010-01-01 | 2013-10-12 | Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropathy | Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropathy | IgA Nephropathy | Experimental Group:Chinese Herb Prescription Granule, 6g, Bid, po. 48 weeks;Placebo Comparator:Placebo of Chinese Herb Prescription Granule, 6g, Bid, po. 48 weeks plus prednisone, 0.5mg-1mg/kg/d, po. 48 weeks; | Department of Nephrology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine | NULL | Completed | 18 | 60 | Both | Experimental Group:100;Placebo Comparator:10; | China | |
| 11 | NCT01879514 (ClinicalTrials.gov) | January 2010 | 25/3/2013 | Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath | Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath | IgA Nephropathy | Drug: Chinese Herb Prescription Granule plus prednisone;Drug: Placebo | Shanghai University of Traditional Chinese Medicine | Shanghai Sixth People's Hospital;RenJi Hospital | Recruiting | 18 Years | 60 Years | Both | 200 | N/A | China |
| 12 | ChiCTR-TRC-09000338 | 2009-04-01 | 2009-02-23 | Full dose of RASS blockade versus steroids therapy in patients with IgA nephropathy | Full dose of RASS blockade versus steroids therapy in patients with IgA nephropathy | IgA nephropathy | Group A:Full dose of RASS blockade (ACEI and ARB blocker);Group B:prednisone ; | The First Affiliated Hospital of Zhejiang University | NULL | Completed | 18 | 70 | Male | Group A:60;Group B:60; | China | |
| 13 | NCT00657059 (ClinicalTrials.gov) | September 2007 | 8/4/2008 | Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN) | A Prospective, Multicenter, Randomized Controlled Trial of Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN) | IgA Nephropathy | Drug: irbesartan;Drug: methylprednisolone (MP) or prednisone (pred);Drug: mycophenolate mofetil (MMF) | Sun Yat-sen University | NULL | Completed | 14 Years | 60 Years | All | 151 | Phase 3 | China |
| 14 | ChiCTR-TRC-06000004 | 2006-01-01 | 2006-09-14 | ACEi/ARB alone versus ACEi/ARB plus Steroids in the treatment of primary IgA nephropathy, a randomized multicenter controlled trial | ACEi/ARB alone versus ACEi/ARB plus Steroids in the treatment of primary IgA nephropathy, a randomized multicenter controlled trial | primary IgA nephropathy | group 1:treated with ACEI/ARB( ARB therapy is subjected to patients with cough after use of ACEI) Inhibace (cilazapril): start at 1.25mg/day, increase the dose by 1.25mg/day/week to 2.5-5mg/day Cozaar (losartan): 25~50mg/day, increased to 50~100mg/day Last for one year;group 2:Oral prednisone for 6 mos 0.8mg/kg/day x 8 wks Tapered 0.2mg/kg/day/mo in combination with ACEI/ARB; | The First Hospital, Peking University | NULL | Completed | 16 | 65 | Both | group 1:78;group 2:78; | China | |
| 15 | NCT00378443 (ClinicalTrials.gov) | January 2006 | 19/9/2006 | ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCT | Glomerulonephritis, IGA | Drug: prednisone + Inhibace/Cozaar;Drug: Inhibace/Cozaar | Peking University | NULL | Active, not recruiting | 16 Years | 65 Years | Both | N/A | NULL | ||
| 16 | NCT01392833 (ClinicalTrials.gov) | December 1999 | 5/7/2011 | Steroids and Azathioprine in Advanced IgAN | Steroids and Azathioprine in Early and Advanced IgA Nephropathy: Amendments to a Prospective Randomised Multicenter Trial | IgA Nephropathy;Chronic Kidney Disease | Drug: methylprednisolone;Drug: azathioprine;Drug: prednisone | A. Manzoni Hospital | NULL | Completed | 16 Years | 70 Years | Both | 46 | Phase 3 | NULL |
79. 家族性高コレステロール血症（ホモ接合体）
臨床試験数 : 145 / 薬物数 : 114 - (DrugBank : 26) / 標的遺伝子数 : 8 - 標的パスウェイ数 : 17
| 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 | EUCTR2016-001446-25-IT (EUCTR) | 02/10/2017 | 06/05/2021 | This is a study to investigate if gene therapy is safe in people with homozygous familial hypercholesterolemia (also called HoFH). | AAV8-mediated Low Density Lipoprotein Receptor (LDLR) Gene Replacement in Subjects with Homozygous Familial Hypercholesterolemia (HoFH) | Adults with homozygous familial hypercholesterolemia;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AAV8.TBG.hLDLR Product Code: AAV8.TBG.hLDLR Product Name: prednisone Product Code: prednisone | REGENXBIO Inc. | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 1;Phase 2 | United States;Canada;Netherlands;Italy |
81. 先天性副腎皮質酵素欠損症
臨床試験数 : 87 / 薬物数 : 87 - (DrugBank : 23) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 68
| 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 | NCT04536662 (ClinicalTrials.gov) | October 1, 2020 | 23/8/2020 | Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21a-hydroxylase Deficiency | Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21a-hydroxylase Deficiency | Congenital Adrenal Hyperplasia | Drug: Hydrocortisone;Drug: Prednisone;Drug: Dexamethasone | Shanghai Jiao Tong University School of Medicine | NULL | Not yet recruiting | 14 Years | 45 Years | All | 120 | Phase 4 | China |
| 2 | NCT03760835 (ClinicalTrials.gov) | August 11, 2016 | 9/11/2018 | Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment | Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment | Congenital Adrenal Hyperplasia | Drug: Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone);Drug: Dual release hydrocortisone (plenadren) | Federico II University | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 4 | Italy |
84. サルコイドーシス
臨床試験数 : 149 / 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 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 | NCT05247554 (ClinicalTrials.gov) | March 1, 2022 | 9/2/2022 | Randomized Controlled Trial of Hydroxychloroquine Combined With Low-dose Corticosteroid in Pulmonary Sarcoidosis | Randomized Controlled Trial Testing the Effect of Hydroxychloroquine Combined With Low-dose Corticosteroid Therapy in Pulmonary Sarcoidosis | Pulmonary Sarcoidosis | Drug: Hydroxychloroquine + low-dose prednisone;Drug: Prednisone | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 18 Years | 80 Years | All | 200 | Phase 3 | NULL |
| 2 | JPRN-jRCTs011210048 | 05/11/2021 | 05/11/2021 | Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial | Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial - CHASM CS- RCT | Cardiac Sarcoidosis Cardiac Sarcoidosis | Subjects meeting the study inclusion/exclusion criteria will be randomized equally to receive either: 1. Prednisone 0.5 mg kg/day for 6-months (MAX dose 30 mg per day) or 2. Methotrexate 15-20 mg po, sc, or IM once a week for 6-months + Folic Acid 2 mg OD for 6 months + Prednisone 20 mg day for 1 month, then 10 mg OD for 1 month, then 5 mg OD for one month then STOP | Toshiyuki Nagai | NULL | Pending | >= 18age old | Not applicable | Both | 194 | Phase 3 | Canada;United States;United Kingdom;Japan |
| 3 | EUCTR2019-004148-31-NL (EUCTR) | 26/02/2020 | 15/11/2019 | The PREDMETH trial: Effectiveness of methotrexate versus prednisone as first-line therapy for pulmonary sarcoidosis – A randomized controlled trial | The PREDMETH trial: Effectiveness of methotrexate versus prednisone as first-line therapy for pulmonary sarcoidosis – A randomized controlled trial - PREDMETH trial | pulmonary sarcoidosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE Trade Name: Prednison Product Name: Prednison INN or Proposed INN: prednisone Other descriptive name: PREDNISONE | Erasmus Medisch Centrum Dept. of Pulmonology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 4 | Netherlands | ||
| 4 | NCT03593759 (ClinicalTrials.gov) | January 15, 2019 | 27/6/2018 | Cardiac Sarcoidosis Randomized Trial | Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial | Cardiac Sarcoidosis;Sarcoidosis | Drug: Prednisone or Prednisolone;Drug: Methotrexate | Ottawa Heart Institute Research Corporation | Canadian Institutes of Health Research (CIHR) | Recruiting | 18 Years | N/A | All | 194 | Phase 3 | United States;Canada;Japan;United Kingdom |
| 5 | NCT03324503 (ClinicalTrials.gov) | December 8, 2017 | 12/10/2017 | A Study to Estimate the Effect Sizes of HRCT Endpoints in Response to Glucocorticoid Induction Therapy in Subjects With Pulmonary Sarcoidosis | A Multicenter, Open-Label Study to Estimate the Effect Sizes of HRCT Endpoints in Response to GLUCOCORTICOID Induction Therapy in Subjects With Pulmonary Sarcoidosis | Sarcoidosis, Pulmonary | Drug: Glucocorticoid (prednisone or prednisolone) | Celgene | NULL | Completed | 18 Years | 65 Years | All | 8 | N/A | United States;Netherlands;United Kingdom |
| 6 | NCT01210677 (ClinicalTrials.gov) | April 2014 | 27/9/2010 | Cardiac Sarcoidosis Response To Steroids Trial | CArdiac Sarcoidosis Response TO steRoids (CASTOR) Trial | Cardiac Sarcoidosis;Sarcoidosis | Drug: Prednisone | Ottawa Heart Institute Research Corporation | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | Canada |
| 7 | NCT02200146 (ClinicalTrials.gov) | March 2009 | 10/7/2014 | Hydroxychloroquine as Steroid-Sparing Agent in Pulmonary Sarcoidosis (HySSAS). | Hydroxychloroquine as Steroid-Sparing Agent in Pulmonary Sarcoidosis (HySSAS). A Multicenter, Prospective, Controlled, Randomized Trial. | Pulmonary Sarcoidosis | Drug: Prednisone;Drug: Hydroxychloroquine + Prednisone | University of Milano Bicocca | Agenzia Italiana del Farmaco | Completed | 18 Years | 70 Years | Both | 94 | Phase 3 | Italy |
| 8 | EUCTR2008-001340-39-IT (EUCTR) | 30/06/2008 | 13/06/2008 | Hydroxychloroquine as Steroid-Sparing Agent in pulmonary Sarcoidosis (HySSAS). A multicenter, prospectic, controlled, randomized trial. - HySSAS | Hydroxychloroquine as Steroid-Sparing Agent in pulmonary Sarcoidosis (HySSAS). A multicenter, prospectic, controlled, randomized trial. - HySSAS | Pulmonary Sarcoidosis | Trade Name: PLAQUENIL*25CPR RIV 200MG INN or Proposed INN: Hydroxychloroquine Trade Name: DELTACORTENE*10CPR 25MG INN or Proposed INN: Prednisone | UNIVERSITA' DEGLI STUDI DI MILANO-BICOCCA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 9 | NCT00000596 (ClinicalTrials.gov) | June 1978 | 27/10/1999 | Diffuse Fibrotic Lung Disease | Lung Diseases;Pulmonary Fibrosis;Sarcoidosis | Drug: prednisone;Drug: cyclophosphamide;Drug: dapsone | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 18 Years | N/A | Both | Phase 2 | NULL |
85. 特発性間質性肺炎
臨床試験数 : 627 / 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
| 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 | NCT05674994 (ClinicalTrials.gov) | March 15, 2023 | 9/12/2022 | Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis | Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled Trial | Acute Exacerbation of Idiopathic Pulmonary Fibrosis | Drug: Methylprednisone/Prednisone;Other: Placebo | Groupe Hospitalier Paris Saint Joseph | NULL | Not yet recruiting | 18 Years | N/A | All | 110 | Phase 3 | France |
| 2 | NCT04534478 (ClinicalTrials.gov) | September 7, 2020 | 31/8/2020 | Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 | Randomized, Open, Parallel, Single-center, Non-inferiority Clinical Trial, With an Active Control Group, Comparing Two Oral Prednisone Regimens With the Aim of Optimizing the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 Infection | COVID-19 Pneumonia | Drug: Prednisone | Hospital Universitari Vall d'Hebron Research Institute | NULL | Not yet recruiting | 18 Years | N/A | All | 120 | Phase 4 | NULL |
| 3 | NCT01432080 (ClinicalTrials.gov) | September 2011 | 8/9/2011 | Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant | Does Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot Study | Respiratory Tract Infections;Bronchiolitis Obliterans;Cryptogenic Organizing Pneumonia;Lung Diseases, Interstitial | Drug: Prednisone;Drug: Azithromycin;Drug: Montelukast;Drug: Symbicort | Maisonneuve-Rosemont Hospital | The Canadian Blood and Marrow Transplant Group | Terminated | 18 Years | N/A | All | 12 | Phase 2 | Canada |
| 4 | NCT00518310 (ClinicalTrials.gov) | May 2005 | 16/8/2007 | Azathioprine and Prednisone in the Treatment of Idiopathic Pulmonary Fibrosis | Azathioprine and Prednisone in the Treatment of Idiopathic Pulmonary Fibrosis: a Randomized, Double-Blind, Controlled Study | Idiopathic Pulmonary Fibrosis | Drug: Placebo;Drug: AZAPRED | Thorax National Institute | Sociedad Chilena de Enfermedades Respiratorias;Servicio de Salud Metropolitano Oriente, Ministerio de Salud de Chile | Recruiting | 45 Years | 79 Years | Both | 100 | N/A | Chile |
| 5 | NCT00052039 (ClinicalTrials.gov) | April 2002 | 21/1/2003 | A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone | A Randomized, Double-Blind, Three-Arm, Phase IIIb Study Comparing the Safety and Efficacy of Interferon Gamma-1b Alone, IFN-Gamma 1b With Azathioprine, and Azathioprine Alone in Patients With Idiopathic Pulmonary Fibrosis Receiving Prednisone | Lung Disease;Pulmonary Fibrosis | Drug: interferon-gamma 1b;Drug: azathioprine | InterMune | NULL | Terminated | 20 Years | 79 Years | Both | 0 | Phase 3 | Italy |
| 6 | NCT00262405 (ClinicalTrials.gov) | January 2001 | 12/9/2005 | Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis | Phase II Trial of Zileuton Compared to Azathioprine/Prednisone for the Treatment of Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: zileuton;Drug: azathioprine/prednisone | University of Michigan | National Institutes of Health (NIH) | Completed | 35 Years | 80 Years | Both | 44 | Phase 2 | United States |
86. 肺動脈性肺高血圧症
臨床試験数 : 1,205 / 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
| 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 | NCT01086540 (ClinicalTrials.gov) | June 24, 2011 | 11/3/2010 | Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | Systemic Sclerosis-Associated PAH | Biological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophen | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Completed | 18 Years | 75 Years | All | 57 | Phase 2 | United States |
95. 自己免疫性肝炎
臨床試験数 : 52 / 薬物数 : 68 - (DrugBank : 27) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 111
| 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 | NCT02463331 (ClinicalTrials.gov) | May 2003 | 18/5/2015 | Possible Role of Chloroquine to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial | Possible Role of Chloroquine in Conjunction to Prednisone to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial | Autoimmune Hepatitis | Drug: Chloroquine diphosphate;Drug: prednisone;Drug: azathioprine | University of Sao Paulo General Hospital | NULL | Completed | 18 Years | N/A | All | 57 | Phase 4 | NULL |
| 2 | NCT00838214 (ClinicalTrials.gov) | March 2001 | 5/2/2009 | Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis | Efficacy and Safety of Budesonide Capsules (3x3mg/d)Versus Prednisone in Patients With a Diagnose of Active Autoimmune Hepatitis. A Double-blind, Randomized, Active-controlled, Multicentre Study | Autoimmune Hepatitis | Drug: budesonide;Drug: prednisone | Dr. Falk Pharma GmbH | NULL | Completed | 10 Years | 70 Years | All | 208 | Phase 2/Phase 3 | Germany |
96. クローン病
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
| 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 | NCT03833596 (ClinicalTrials.gov) | October 25, 2018 | 21/12/2018 | Exclusive Enteral Nutrition and Corticosteroids Therapy in Crohn's Disease (EENCD) | Synergistic Effect of Exclusive Enteral Nutrition Formula in Addition to Corticosteroids Therapy to Induce Clinical Remission in Patients With Crohn's Disease: a Pilot Study Involving a Multidimensional Assessment of Potential Mechanisms | Crohn's Disease | Drug: Prednisone;Dietary Supplement: Exclusive Enteral Nutrition | McMaster University | Nestlé | Terminated | 18 Years | 75 Years | All | 3 | Phase 4 | Canada |
| 2 | NCT02324699 (ClinicalTrials.gov) | April 2016 | 19/12/2014 | Corticosteroids With Vedolizumab in Crohn's Disease | Corticosteroids as Co-Induction Agents With Vedolizumab in Crohn's Disease: a Double-blind Placebo Controlled Randomized Trial | Crohn's Disease | Drug: Prednisone;Drug: Placebo;Drug: Vedolizumab | Icahn School of Medicine at Mount Sinai | Takeda | Terminated | 18 Years | 70 Years | All | 1 | Phase 4 | United States |
| 3 | ChiCTR-IIR-16007751 | 2016-01-01 | 2016-01-13 | Clinical study of acupuncture and moxibustion treatment for Cohn's disease | Molecular regulation mechanism of acupuncture and moxibustion therapy in inhibiting epithelial-mesenchymal transition of intestinal fibrosis in Crohn's disease | Crohn's disease | Acupuncture Group:Acupuncture, Moxibustion, Prednisone and azathioprine;Placebo acupuncture group:Placebo acupuncture, moxibustion, Prednisone and azathioprine;Drug Group:Prednisone and azathioprine; | Shanghai Research Institute of Acupuncture and Meridian | NULL | Recruiting | 16 | 70 | Both | Acupuncture Group:40;Placebo acupuncture group:40;Drug Group:40; | I (Phase 1 study) | China |
| 4 | EUCTR2010-020137-10-LT (EUCTR) | 13/05/2015 | 12/03/2015 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 5 | EUCTR2010-020137-10-HU (EUCTR) | 12/01/2012 | 22/11/2011 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Germany;Netherlands;Sweden | ||
| 6 | EUCTR2010-020137-10-BE (EUCTR) | 23/03/2011 | 04/10/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 7 | NCT01235689 (ClinicalTrials.gov) | February 11, 2011 | 4/11/2010 | Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's Disease | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: Adalimumab;Drug: Prednisone;Drug: Azathioprine | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 75 Years | All | 252 | Phase 3 | Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 8 | EUCTR2010-020137-10-NL (EUCTR) | 17/12/2010 | 23/12/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany;Sweden | ||
| 9 | EUCTR2010-020137-10-CZ (EUCTR) | 08/11/2010 | 04/08/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 10 | EUCTR2010-020137-10-IT (EUCTR) | 07/11/2010 | 08/11/2010 | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn`s Disease. - CALM | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn`s Disease. - CALM | Crohn`s disease. MedDRA version: 9.1;Level: LLT;Classification code 10011401 | Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T INN or Proposed INN: Adalimumab Trade Name: Azathioprin-ratiopharm 25 mg INN or Proposed INN: Azathioprine Trade Name: Azathioprine - ratiopharm 50 mg INN or Proposed INN: Azathioprine Trade Name: Decortin 5 mg INN or Proposed INN: Prednisone Trade Name: Decortin 20 mg INN or Proposed INN: Prednisone | Abbott GmBH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 11 | EUCTR2010-020137-10-ES (EUCTR) | 20/10/2010 | 20/08/2010 | Estudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Estudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Enfermedad de Crohn.Crohn's disease MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 12 | EUCTR2010-020137-10-FR (EUCTR) | 14/10/2010 | 23/08/2010 | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 13 | EUCTR2010-020137-10-DE (EUCTR) | 05/10/2010 | 20/07/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 14 | EUCTR2010-020137-10-GB (EUCTR) | 20/09/2010 | 19/07/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 15 | EUCTR2010-020137-10-AT (EUCTR) | 16/09/2010 | 11/08/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 16 | EUCTR2010-020137-10-SE (EUCTR) | 15/09/2010 | 27/07/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 17 | EUCTR2006-003870-88-DE (EUCTR) | 27/11/2006 | 29/09/2006 | A Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR I | A Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR I | In the present study, the corticosteroid-sparing effect of certolizumab pegol will be assessed in patients with moderate to severe Crohn’s disease who have received initial acute corticosteroid therapy (prednisone or prednisolone) for induction of remission. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 352 | Phase 3 | Germany | ||
| 18 | NCT00098111 (ClinicalTrials.gov) | April 2005 | 3/12/2004 | Imuran (Azathioprine) Dose-Ranging Study in Crohn's Disease | A Double-Blinded, Randomized, Parallel Arm, Dose Ranging Study of IMURAN in Subjects With Active Crohn's Disease Requiring Treatment With Prednisone: A Crohn's Disease Optimal Range Dose of IMURAN Study (ACORDIS) | Crohn's Disease | Drug: azathioprine | Massachusetts General Hospital | NULL | Terminated | 14 Years | N/A | Both | 31 | Phase 3 | United States |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| 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 | NCT04882683 (ClinicalTrials.gov) | June 1, 2021 | 6/5/2021 | Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis | Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis | Ulcerative Colitis | Drug: Prednisone;Drug: Azathioprine;Drug: Adalimumab;Biological: umbilical cord blood mononuclear cells | Shandong Qilu Stem Cells Engineering Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 50 | N/A | China |
| 2 | ChiCTR2100046284 | 2021-05-06 | 2021-05-12 | Clinical study of cord blood mononuclear cells on treatment of hormone-resistant or hormone-dependent ulcerative colitis | Clinical study of cord blood mononuclear cells on treatment of hormone-resistant or hormone-dependent ulcerative colitis | ulcerative colitis | Control group:Prednisone+Azathioprine/Adalimumab;Test group:Prednisone+Azathioprine/Adalimumab+umbilical cord blood mononuclear cells; | The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | Control group:25;Test group:25; | China | |
| 3 | EUCTR2020-003420-16-IT (EUCTR) | 29/01/2021 | 02/08/2021 | A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis. | SPRINT_”AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MODERATE TO SEVERE ULCERATIVE COLITIS.” - SPRINT | Moderate to severe ulcerative colitis. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amgevita Product Name: Adalimumab Product Code: [n.d.] INN or Proposed INN: ADALIMUMAB Product Name: Azatioprina Product Code: [n.d.] INN or Proposed INN: AZATIOPRINA Product Name: Prednisone Product Code: [n.d.] INN or Proposed INN: PREDNISONE INN or Proposed INN: PREDNISONE | IRCCS ISTITUTO CLINICO HUMANITAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 4 | Portugal;France;Spain;Belgium;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 4 | ChiCTR1900024591 | 2019-07-22 | 2019-07-18 | Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis | Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis | Ulcerative colitis | TCM Group:Prednisone+New Wumeiwan Formula;Convenience medicine Group:Prednisone+Mesalazine Enteric-coated tablets (Salofalk);Combined Group:Prednisone+New Wumeiwan Formula+Mesalazine Enteric-coated tablets(Salofalk); | Peking University First Hospital | NULL | Pending | 18 | 65 | Both | TCM Group:40;Convenience medicine Group:40;Combined Group:40; | China | |
| 5 | ITMCTR1900002475 | 2019-07-22 | 2019-07-18 | Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis | Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis | Ulcerative colitis | Combined Group:Prednisone+New Wumeiwan Formula+Mesalazine Enteric-coated tablets(Salofalk);Convenience medicine Group:Prednisone+Mesalazine Enteric-coated tablets (Salofalk);TCM Group:Prednisone+New Wumeiwan Formula; | Peking University First Hospital | NULL | Pending | 18 | 65 | Both | Combined Group:40;Convenience medicine Group:40;TCM Group:40; | CHINA | |
| 6 | NCT02921555 (ClinicalTrials.gov) | October 11, 2018 | 22/9/2016 | Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis | Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis. | Ulcerative Colitis | Drug: Methylprednisolone;Drug: Prednisone | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa | NULL | Completed | 18 Years | N/A | All | 75 | Phase 4 | Spain |
| 7 | NCT02910245 (ClinicalTrials.gov) | November 2016 | 9/9/2016 | Mercaptopurine Therapy in Ulcerative Colitis | Efficacy of Optimized Thiopurine Therapy in Ulcerative Colitis (OPTIC) | Colitis, Ulcerative | Drug: Mercaptopurine (Purinethol);Drug: Placebo;Drug: Mesalamine;Drug: Prednisone | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | ZonMw: The Netherlands Organisation for Health Research and Development | Recruiting | 18 Years | 80 Years | All | 136 | Phase 3 | Netherlands |
| 8 | ChiCTR-ICR-15007188 | 2015-10-09 | 2015-10-09 | Percutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trial | Percutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trial | Ulcerative colitis | Percutaneous endoscopic mini-colostomy group:Oral steroids (prednisone 1mg.kg-1d-1) +Percutaneous endoscopic mini-colostomy andsubsequent drug delivery (mesalazine 3g / d);Control Group:Oral steroids (prednisone 1mg.kg-1d-1) andmesalazine 3g / d; | Southern Medical University, Nanfang Hospital, Department of Gastroenterology | NULL | Recruiting | Both | Percutaneous endoscopic mini-colostomy group:21;Control Group:21; | China | |||
| 9 | EUCTR2007-003815-30-PT (EUCTR) | 31/07/2009 | 05/03/2009 | An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone plus Adacolumn® GMA Apheresis versus Prednisone Alone in the Treatment of Patients with Mild or Moderately Active Steroid Dependent Ulcerative Colitis | An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone plus Adacolumn® GMA Apheresis versus Prednisone Alone in the Treatment of Patients with Mild or Moderately Active Steroid Dependent Ulcerative Colitis | Mild or Moderately Active Steroid Dependent Ulcerative Colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Dacortin Product Name: prednisone INN or Proposed INN: Prednisone INN or Proposed INN: Prednisone Trade Name: Dacortin Product Name: prednisone Product Code: H02AB INN or Proposed INN: PREDNISONE INN or Proposed INN: PREDNISONE | GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa) | NULL | Not Recruiting | Female: yes Male: yes | Portugal;Spain | ||||
| 10 | EUCTR2006-004230-32-BE (EUCTR) | 21/12/2007 | 04/12/2007 | Efficacy and safety of Beclomethasone dipropionate, gastro-resistant, prolonged release tablets (CHF1514) compared to oral prednisone, in a 8-week treatment period, in patients with active ulcerative colitis. An international, multicentre, randomized, double blind, parallel group study. - Beta study | Efficacy and safety of Beclomethasone dipropionate, gastro-resistant, prolonged release tablets (CHF1514) compared to oral prednisone, in a 8-week treatment period, in patients with active ulcerative colitis. An international, multicentre, randomized, double blind, parallel group study. - Beta study | Ulcerative colitis extending proximally beyond the rectum. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Clipper 30 cpr 5mg R.M. INN or Proposed INN: BECLOMETASONE DIPROPIONATE Trade Name: Deltacortene 20 cpr 5mg INN or Proposed INN: PREDNISONE Trade Name: Deltacortene 10 cpr 25mg INN or Proposed INN: PREDNISONE | CHIESI Farmaceutici S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Belgium;Spain;Italy;Poland | |||
| 11 | EUCTR2006-004230-32-PL (EUCTR) | 07/12/2007 | 05/09/2007 | EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study | EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study | Ulcerative Colitis extending proximally beyond the rectum with bleeding, verified by endoscopic examination MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Clipper INN or Proposed INN: Beclomethasone diproprionate Trade Name: Deltacortene INN or Proposed INN: Prednisone Trade Name: Deltacortene INN or Proposed INN: Prednisone | Chiesi Farmaceutici SpA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Belgium;Spain;Poland;Italy | ||
| 12 | EUCTR2007-003815-30-ES (EUCTR) | 27/11/2007 | 24/10/2007 | Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada. | Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada. | Colitis ulcerosa corticodependiente leve o moderada MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: DACORTIN Product Name: PREDNISONE INN or Proposed INN: PREDNISONE Other descriptive name: N/A | GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa) | NULL | Not Recruiting | Female: yes Male: yes | Portugal;Spain | ||||
| 13 | EUCTR2006-004230-32-ES (EUCTR) | 22/08/2007 | 26/09/2007 | EFICACIA Y SEGURIDAD DE COMPRIMIDOS DE BECLOMETASONA DIPROPIONATO (CHF1514) GASTRORRESISTENTES DE LIBERACIÓN PROLONGADA, FRENTE A PREDNISONA ORAL, DURANTE UN PERIODO DE TRATAMIENTO DE 8 SEMANAS EN PACIENTES CON COLITIS ULCEROSA ACTIVA. ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE GRUPOS PARALELOS. - Estudio BETA | EFICACIA Y SEGURIDAD DE COMPRIMIDOS DE BECLOMETASONA DIPROPIONATO (CHF1514) GASTRORRESISTENTES DE LIBERACIÓN PROLONGADA, FRENTE A PREDNISONA ORAL, DURANTE UN PERIODO DE TRATAMIENTO DE 8 SEMANAS EN PACIENTES CON COLITIS ULCEROSA ACTIVA. ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE GRUPOS PARALELOS. - Estudio BETA | Colitis ulcerosa activa, extendiéndose en sentido proximal más allá del recto. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Clipper INN or Proposed INN: BECLOMETASONE DIPROPIONATE Trade Name: Deltacortene INN or Proposed INN: PREDNISONE Trade Name: Deltacortene INN or Proposed INN: PREDNISONE | Chiesi Farmaceutici SpA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Belgium;Poland;Spain;Italy | ||
| 14 | EUCTR2006-004230-32-IT (EUCTR) | 06/06/2007 | 12/11/2007 | Efficacy and safety of beclometasone dipropionate (BDP) gastro-resistant prolonged release tablets (CHF1514) compared to oral steroid (prednisone) in an 8-week treatment period in patients with active moderate ulcerative colitis. A multicentre, randomised, controlled, double blind, parallel group study. Beta study - BETA | Efficacy and safety of beclometasone dipropionate (BDP) gastro-resistant prolonged release tablets (CHF1514) compared to oral steroid (prednisone) in an 8-week treatment period in patients with active moderate ulcerative colitis. A multicentre, randomised, controlled, double blind, parallel group study. Beta study - BETA | Mild moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: CLIPPER*30CPR 5MG R.M. INN or Proposed INN: Beclometasone Trade Name: DELTACORTENE*20CPR 5MG INN or Proposed INN: Prednisone Trade Name: DELTACORTENE FORTE*10CPR 25MG INN or Proposed INN: Prednisone | CHIESI | NULL | Not Recruiting | Female: yes Male: yes | 300 | Belgium;Spain;Italy;Poland |
113. 筋ジストロフィー
臨床試験数 : 646 / 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
| 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 | NCT04322357 (ClinicalTrials.gov) | July 30, 2020 | 24/3/2020 | Weekend Steroids and Exercise as Therapy for DMD | Impact and Interplay of Corticosteroid Regimen and Exercise Training on DMD Muscle Function | Duchenne Muscular Dystrophy (DMD) | Drug: Prednisone;Behavioral: In-home Exercise Training;Drug: Prednisone with daily edasalonexent;Drug: Prednisone plus exercise | University of Florida | U.S. Army Medical Research and Development Command;Catabasis Pharmaceuticals | Recruiting | 5 Years | 8 Years | Male | 89 | Phase 2 | United States |
| 2 | EUCTR2017-002704-27-NL (EUCTR) | 10/10/2019 | 25/02/2019 | A Study to Assess the efficacy and the safety of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD) | A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - VISION DMD | Duchenne muscular dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: VAMOROLONE Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: VAMOROLONE Product Name: Prednisone INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ReveraGen BioPharma, Inc. | NULL | Not Recruiting | Female: no Male: yes | 120 | Phase 2 | United States;Czechia;Greece;Spain;Israel;Italy;United Kingdom;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 3 | EUCTR2017-002704-27-ES (EUCTR) | 13/08/2019 | 11/06/2019 | A Study to Assess the efficacy and the safety of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD) | A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - VISION DMD | Duchenne muscular dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: VAMOROLONE Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: VAMOROLONE Product Name: Prednisone INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ReveraGen BioPharma, Inc. | NULL | Not Recruiting | Female: no Male: yes | 120 | Phase 2 | United States;Greece;Spain;Israel;Italy;United Kingdom;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 4 | EUCTR2017-002704-27-GR (EUCTR) | 01/08/2019 | 10/06/2019 | A Study to Assess the efficacy and the safety of Vamorolone in Boys withDuchenne Muscular Dystrophy (DMD) | A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- andActive-controlled Study with Double-Blind Extension to Assess the Efficacyand Safety of Vamorolone in Ambulant Boys with Duchenne MuscularDystrophy (DMD) - VISION DMD | Duchenne muscular dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: VAMOROLONE Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: VAMOROLONE Product Name: Prednisone INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ReveraGen BioPharma, Inc | NULL | Not Recruiting | Female: no Male: yes | 120 | Phase 2 | Czech Republic;Canada;Greece;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2017-002704-27-BE (EUCTR) | 06/07/2019 | 21/02/2018 | A Study to Assess the efficacy and the safety of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD) | A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - VISION DMD | Duchenne muscular dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: VAMOROLONE Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: VAMOROLONE Product Name: Prednisone INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ReveraGen BioPharma, Inc. | NULL | Not Recruiting | Female: no Male: yes | 120 | Phase 2 | United States;Czechia;Greece;Spain;Israel;Italy;United Kingdom;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 6 | NCT04054375 (ClinicalTrials.gov) | July 1, 2019 | 7/8/2019 | Weekly Steroids in Muscular Dystrophy | Open Label Safety and Efficacy of Once Weekly Steroid in Patients With LGMD and Becker Muscular Dystrophy | Limb-girdle Muscular Dystrophy;Becker Muscular Dystrophy | Drug: Prednisone | Northwestern University | NULL | Active, not recruiting | 18 Years | 65 Years | All | 20 | Phase 2 | United States |
| 7 | EUCTR2017-002704-27-CZ (EUCTR) | 19/06/2019 | 22/03/2019 | A Study to Assess the efficacy and the safety of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD) | A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - VISION DMD | Duchenne muscular dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: VAMOROLONE Product Name: Prednisone INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: VAMOROLONE | ReveraGen BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 120 | Phase 2 | United States;Greece;Spain;Israel;United Kingdom;Italy;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 8 | EUCTR2017-002704-27-GB (EUCTR) | 21/09/2018 | 25/06/2019 | A Study to Assess the efficacy and the safety of Vamorolone in comparison to Prednisone in Boys with Duchenne Muscular Dystrophy (DMD) | A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - VISION DMD | Duchenne muscular dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: VAMOROLONE Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: VAMOROLONE Product Name: Prednisone INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ReveraGen BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 120 | Phase 2 | United States;Greece;Spain;Israel;United Kingdom;Italy;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 9 | EUCTR2017-002704-27-SE (EUCTR) | 15/08/2018 | 12/03/2018 | A Study to Assess the efficacy and the safety of Vamorolone in Boys with Duchenne Muscular Dystrophy (DMD) | A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - VISION DMD | Duchenne muscular dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: VAMOROLONE Product Name: Vamorolone Product Code: VBP15 INN or Proposed INN: VAMOROLONE Product Name: Prednisone INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ReveraGen BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 120 | Phase 2 | United States;Czechia;Greece;Spain;Israel;Italy;United Kingdom;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 10 | NCT03439670 (ClinicalTrials.gov) | June 29, 2018 | 9/1/2018 | A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) | A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study With Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys With Duchenne Muscular Dystrophy (DMD) | Duchenne Muscular Dystrophy | Drug: Vamorolone;Drug: Prednisone;Other: Placebo | ReveraGen BioPharma, Inc. | European Union;Cooperative International Neuromuscular Research Group;Newcastle University;University of Pittsburgh | Completed | 4 Years | 7 Years | Male | 121 | Phase 2 | United States;Australia;Belgium;Canada;Czechia;Greece;Israel;Netherlands;Spain;Sweden;United Kingdom;Germany;Italy |
| 11 | NCT02036463 (ClinicalTrials.gov) | November 2014 | 6/1/2014 | A Trial of Chronotherapy of Corticosteroids in Duchenne Muscular Dystrophy | CINRG0513: A Trial of Chronotherapy of Corticosteroids in Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy (DMD) | Drug: Prednisone;Drug: Placebo | Ann & Robert H Lurie Children's Hospital of Chicago | Children's Research Institute | Withdrawn | 3 Years | 6 Years | Male | 0 | Phase 2 | United States |
| 12 | EUCTR2010-023744-33-IT (EUCTR) | 26/02/2013 | 28/12/2012 | Duchenne muscular dystrophy: a clinical trial to find the optimum steroid regimen. | Duchenne muscular dystrophy: double-blind randomized trial to find optimum steroid regimen. - FOR-DMD | Duchenne muscular dystrophy boys between 4 and 8 years of age, able to rise from the floor without support, not previously treated with steroids. MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: DELTACORTENE*20CPR 5MG INN or Proposed INN: PREDNISONE Trade Name: DELTACORTENE*20CPR 5MG INN or Proposed INN: PREDNISONE Trade Name: DEFLAN*10CPR 6MG INN or Proposed INN: DEFLAZACORT | AZIENDA OSPEDALIERA DI PADOVA | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 300 | United States;Canada;United Kingdom;Italy | |||
| 13 | EUCTR2010-023744-33-GB (EUCTR) | 12/11/2012 | 20/09/2012 | Trial to find best steroid treatment for Duchenne muscular dystrophy | Duchenne muscular dystrophy: double-blind randomized trial to find optimum steroid regimen - FOR-DMD | Duchenne muscular dystrophy (DMD) MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Deflazacort Product Name: Deflazacort 6 mg Tablets INN or Proposed INN: Deflazacort Trade Name: Prednisone Product Name: Prednisone 5 mg tablets INN or Proposed INN: Prednisone | University of Rochester | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 300 | United States;Canada;Germany;Italy;United Kingdom | |||
| 14 | NCT00308113 (ClinicalTrials.gov) | April 2007 | 27/3/2006 | CoQ10 and Prednisone in Non-Ambulatory DMD | PITT0503: Clinical Trial of Coenzyme Q10 and Prednisone in Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy | Drug: Prednisone;Dietary Supplement: Coenzyme Q10 | Cooperative International Neuromuscular Research Group | United States Department of Defense | Terminated | 10 Years | 18 Years | Male | 3 | Phase 3 | United States;Australia;Puerto Rico |
| 15 | NCT00110669 (ClinicalTrials.gov) | January 2004 | 12/5/2005 | High-dose Prednisone in Duchenne Muscular Dystrophy | A Randomized Study of Daily vs. High-dose Weekly Prednisone Therapy in Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy | Drug: Prednisone | Cooperative International Neuromuscular Research Group | NULL | Completed | 4 Years | 10 Years | Male | 64 | Phase 3 | United States;India |
| 16 | NCT00004646 (ClinicalTrials.gov) | April 1995 | 24/2/2000 | Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy | Drug: prednisone | National Center for Research Resources (NCRR) | National Institute of Neurological Disorders and Stroke (NINDS);University of Rochester | Completed | 5 Years | 15 Years | Male | 20 | Phase 3 | NULL |
162. 類天疱瘡（後天性表皮水疱症を含む。）
臨床試験数 : 90 / 薬物数 : 122 - (DrugBank : 47) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 144
| 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 | NCT05267600 (ClinicalTrials.gov) | June 9, 2022 | 14/2/2022 | A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid (BALLAD) | A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid | Bullous Pemphigoid | Biological: efgartigimod PH20 SC;Other: placebo;Drug: Prednisone | argenx | NULL | Recruiting | 18 Years | N/A | All | 160 | Phase 2/Phase 3 | United States;Australia;Bulgaria;Croatia;France;Germany;Greece;Hungary;Israel;Italy;Latvia;Netherlands;Poland;Serbia;Spain;United Kingdom |
| 2 | ChiCTR2000029007 | 2020-01-01 | 2020-01-11 | Clinical observation of subclinical dosage of cyclosporine combined with glucocorticoid in the treatment of moderate and severe bullous pemphigoid | Clinical observation of subclinical dosage of cyclosporine combined with glucocorticoid in the treatment of moderate and severe bullous pemphigoid | Bullous Pemphigoid | experimental group:subclinical dosage of Cyclosporine, Prednisone or Methylprednisolone and Halometasone Cream.;control group:Prednisone or Methylprednisolone, Halometasone Cream; | The First Affiliated Hospital of Kunming Medical University | NULL | Recruiting | Both | experimental group:30;control group:30; | Phase 4 | China | ||
| 3 | EUCTR2018-001417-32-FR (EUCTR) | 13/07/2018 | 11/06/2018 | Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3 | Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3. Immunological, clinical and medicoeconomic evaluation | Patients with Bullous pemphigoid included in RITUXIMAB3 study MedDRA version: 20.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: MABTHERA INN or Proposed INN: RITUXIMAB Trade Name: Prednisone Product Name: CORTANCYL 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednisone Product Name: CORTANCYL 20 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | CHU-Hôpitaux de Rouen | NULL | Not Recruiting | Female: yes Male: yes | 77 | Phase 3 | France | ||
| 4 | NCT02837965 (ClinicalTrials.gov) | April 2013 | 24/6/2016 | Observational Study Assessing Outcomes, Treatment Patterns and Related Costs in Patients in Bullous Pemphigoid | Multicenter Prospective Observational Study Assessing Outcomes, Adverse Events, Treatment Patterns and Related Costs in Patients Diagnosed With Bullous Pemphigoid | Bullous Pemphigoid | Drug: treatment with topical superpotent corticosteroid therapy;Drug: treatment with systemic therapy (methotrexate);Drug: treatment systemic therapy (prednisone);Drug: treatment with systemic therapy (prednisone);Drug: treatment with systemic therapy (doxycycline) | CHU de Reims | NULL | Recruiting | 18 Years | N/A | Both | 150 | N/A | France |
| 5 | ChiCTR-TRC-12003593 | 2011-08-01 | 2012-12-30 | Use of Oral Methotrexate plus Glucocorticoid for the Treatment of bullous pemphigoid:A multicenter,randomized and controlled clinincal trial | Guideline-oriented Research in the Management of Some Common and Severe Skin Diseases | bullous pemphigoid | Glucocorticoids group:This group receives systemic glucocorticoid, initially, with prednisone at 1mg/kg/day. Then we adjust the dose of glucocorticoid according to the patients' responses.;Glucocorticoid plus MTX group:This group receives systemic glucocorticoid plus MTX and starts with prednisone at 1mg/kg/day and MTX IV drip infusion at 15mg/week. Then we adjust the dose of glucocorticoid according to the patients' responses.; | Institute of dermatology; Chinese Academy of Medical Sciences | NULL | Completed | 18 | Both | Glucocorticoids group:90;Glucocorticoid plus MTX group:90; | China | ||
| 6 | ChiCTR-TRC-12003538 | 2011-08-01 | 2012-12-27 | Use of inravenous Methotrexate plus Glucocorticoid for the Treatment of bullous pemphigoid:A multicenter,randomized and controlled clinincal trial | Guideline-oriented Research in the Management of Some Common and Severe Skin Diseases | Bullous pemphigoid | Glucocorticoids group:This group receives systemic glucocorticoid, initially, with prednisone at 1mg/kg/day. Then we adjust the dose of glucocorticoid according to the patients' responses;Glucocorticoid plus MTX group:This group receives systemic glucocorticoid plus MTX and starts with prednisone at 1mg/kg/day and MTX IV drip infusion at 15mg/week. Then we adjust the dose of glucocorticoid according to the patients' responses.; | Institute of dermatology, Chinese Academy of Medical Sciences | NULL | Recruiting | 18 | 0 | Both | Glucocorticoids group:90;Glucocorticoid plus MTX group:90; | China | |
| 7 | EUCTR2008-005266-31-FR (EUCTR) | 06/02/2009 | 13/03/2009 | COMPARAISON D'UN TRAITEMENT PAR L'ANTICORPS MONOCLONAL ANTI-CD 20 : RITUXIMAB (MABTHERA®) ASSOCIE A UNE CORTICOTHERAPIE GENERALE COURTE PAR RAPPORT A UNE CORTICOTHERAPIE GENERALE DE LONGUE DUREE CHEZ LES PATIENTS ATTEINTS DE PEMPHIGUS - Rituximab III | COMPARAISON D'UN TRAITEMENT PAR L'ANTICORPS MONOCLONAL ANTI-CD 20 : RITUXIMAB (MABTHERA®) ASSOCIE A UNE CORTICOTHERAPIE GENERALE COURTE PAR RAPPORT A UNE CORTICOTHERAPIE GENERALE DE LONGUE DUREE CHEZ LES PATIENTS ATTEINTS DE PEMPHIGUS - Rituximab III | Pemphogoide bulleuse MedDRA version: 9.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid | Trade Name: mabthéra Product Name: mathéra Trade Name: Prednisone Product Name: CORTANCYL 20 mg | CHU-Hôpitaux de Rouen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 8 | NCT00472030 (ClinicalTrials.gov) | August 2007 | 8/5/2007 | Efficacy and Safety of Omalizumab in Bullous Pemphigoid | An Open Label Case Series on the Effects of Xolair (Omalizumab) in Bullous Pemphigoid | Bullous Pemphigoid | Drug: Omalizumab;Drug: prednisone | University of Iowa | Genentech, Inc. | Completed | 18 Years | N/A | All | 2 | Phase 4 | United States |
164. 眼皮膚白皮症
臨床試験数 : 15 / 薬物数 : 54 - (DrugBank : 34) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 141
| 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 | NCT00006054 (ClinicalTrials.gov) | March 2000 | 5/7/2000 | Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies | Immunologic Deficiency Syndromes;Chediak-Higashi Syndrome;Common Variable Immunodeficiency;Graft Versus Host Disease;X-Linked Lymphoproliferative Syndrome;Familial Erythrophagocytic Lymphohistiocytosis;Hemophagocytic Lymphohistiocytosis;X-linked Agammaglobulinemia;Wiskott-Aldrich Syndrome;Chronic Granulomatous Disease;X-linked Hyper IgM Syndrome;Severe Combined Immunodeficiency;Leukocyte Adhesion Deficiency Syndrome;Virus-Associated Hemophagocytic Syndrome | Drug: anti-thymocyte globulin;Drug: busulfan;Drug: cyclophosphamide;Drug: cyclosporine;Drug: etoposide;Drug: methotrexate;Drug: methylprednisolone;Drug: prednisone;Procedure: Allogeneic Bone Marrow Transplantation | Fairview University Medical Center | NULL | Terminated | N/A | 35 Years | Both | N/A | United States |
205. 脆弱Ｘ症候群関連疾患
臨床試験数 : 5 / 薬物数 : 7 - (DrugBank : 5) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 25
| 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 | NCT00033293 (ClinicalTrials.gov) | March 15, 2004 | 9/4/2002 | Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma | A Pilot Study Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone | Disseminated Neuroblastoma;Localized Resectable Neuroblastoma;Localized Unresectable Neuroblastoma;Regional Neuroblastoma;Stage 4S Neuroblastoma | Biological: therapeutic immune globulin;Other: clinical observation;Drug: cyclophosphamide;Drug: prednisone;Procedure: magnetic resonance imaging;Other: laboratory biomarker analysis;Drug: Corticotropin-Releasing Hormone | Children's Oncology Group | National Cancer Institute (NCI) | Active, not recruiting | N/A | 8 Years | All | 53 | Phase 3 | United States;Australia;Canada;Netherlands;New Zealand;Puerto Rico;Switzerland |
222. 一次性ネフローゼ症候群
臨床試験数 : 310 / 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
| 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 | NCT05772871 (ClinicalTrials.gov) | March 30, 2023 | 24/2/2023 | The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children | Compare the Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule Versus Combined With Levamisole for Primary Nephrotic Syndrome in Children: A Prospective, Multi-center, Randomized, Double-blind, Non-inferiority Study | Nephrotic Syndrome in Children | Drug: Huaiqihuang granule;Drug: Prednisone;Drug: Levamisole placebo;Drug: Levamisole;Drug: Huaiqihuang Granule placebo | Jianhua Zhou | LinkDoc Technology (Beijing) Co. Ltd. | Not yet recruiting | 18 Months | 18 Years | All | 402 | Phase 4 | NULL |
| 2 | NCT04745728 (ClinicalTrials.gov) | April 14, 2021 | 4/2/2021 | Different Immunosuppressive Treatment in iMN | Different Immunosuppressive Treatment in Idiopathic Membranous Nephropathy: a Prospective Cohort | Idiopathic Membranous Nephropathy | Drug: Prednisone;Drug: Cyclophosphamide;Drug: Rituximab | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 200 | Phase 3 | China |
| 3 | ChiCTR2100041655 | 2020-12-30 | 2021-01-01 | Effect of thymosin 1 on recurrent minor nephrotic syndrome in adults | A prospective, randomized controlled trial of oral prednisone combined with thymosin 1 in recurrent adult patients with minimal lesions nephrotic syndrome | Minimal change nephrotic syndrome | Oral prednisone:oral prednisone;Oral prednisone combined with thymosin 1 group:Thymosin 1 was injected; | Affiliated Hospital of Guangdong Medical University | NULL | Recruiting | 18 | 70 | Both | Oral prednisone:27;Oral prednisone combined with thymosin 1 group:27; | China | |
| 4 | ChiCTR2000037014 | 2020-10-01 | 2020-08-26 | The predictive value of gut permeability in children with steroid dependent nephrotic syndrome | The predictive value of gut permeability in children with steroid dependent nephrotic syndrome | Primary nephrotic syndrome | Steroid sensitive nephrotic syndrome group (SSNS group):Prednisone treatment recommended by the guidelines;Steroid dependent nephrotic syndrome group (SDNS group):Prednisone treatment recommended by the guidelines; | Shanghai Children's Hospital | NULL | Pending | Both | Steroid sensitive nephrotic syndrome group (SSNS group):40;Steroid dependent nephrotic syndrome group (SDNS group):30; | China | |||
| 5 | NCT03970577 (ClinicalTrials.gov) | July 29, 2020 | 15/4/2019 | RItuximab From the FIRst Episode of Idiopathic Nephrotic Syndrome | Rituximab From the First Episode of Minimal Change Nephrotic Syndrome for Preventing Relapse Risk in Adult Patients: a Multicenter Randomized Controlled Trial | Minimal Change Nephrotic Syndrome (MCNS) | Drug: Rituximab;Drug: Prednisone | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 18 Years | N/A | All | 148 | Phase 2 | France |
| 6 | ChiCTR2000033766 | 2020-07-01 | 2020-06-11 | Diagnostic value of serum C4d, PLA2R, THSD7A antibody in idiopathic membranous nephropathy and analysis of therapeutic effect of tacrolimus | Diagnostic value of serum C4d, PLA2R, THSD7A antibody in idiopathic membranous nephropathy and analysis of therapeutic effect of tacrolimus | Membranous nephropathy | 1:Prednisone + cyclophosphamide;2:Prednisone + Tacrolimus; | The First Affiliated Hospital of Bengbu Medical College | NULL | Pending | 17 | 70 | Both | 1:30;2:30; | Phase 4 | China |
| 7 | NCT04424862 (ClinicalTrials.gov) | June 9, 2020 | 7/6/2020 | Multitarget Therapy for Idiopathic Membranous Nephropathy | Multitarget Therapy for Idiopathic Membranous Nephropathy | Efficacy | Drug: Prednisone, ciclosporin and mycophenolate mofetil;Drug: Ponticelli Regimen | Beijing Friendship Hospital | NULL | Completed | 18 Years | 70 Years | All | 82 | Phase 4 | China |
| 8 | EUCTR2018-003437-15-FR (EUCTR) | 03/04/2019 | 27/02/2019 | Rituximab from the FIRst Episode of Idiopathic Nephrotic Syndrome | Rituximab from the FIRst Episode of Idiopathic Nephrotic Syndrome - RIFIREINS | Minimal Change Nephrotic Syndrome (MCNS) MedDRA version: 20.0;Level: LLT;Classification code 10029168;Term: Nephrotic syndrome with lesion of minimal change glomerulonephritis;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France | ||
| 9 | NCT03864250 (ClinicalTrials.gov) | November 26, 2018 | 4/3/2019 | Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy | Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy: A Randomized, Open, Controlled, Multicenter Clinical Trial | Tacrolimus;Idiopathic Membranous Nephropathy;Clinical Trial | Drug: Tacrolimus;Drug: Prednisone | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | NULL | Recruiting | 18 Years | 80 Years | All | 124 | N/A | China |
| 10 | NCT03298698 (ClinicalTrials.gov) | August 22, 2018 | 24/8/2017 | Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome | Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome Unresponsive to 8 Weeks of High Dose Prednisone | Idiopathic Nephrotic Syndrome;Minimal Change Disease;Focal Segmental Glomerulosclerosis | Drug: Rituximab;Drug: Prednisone | Radboud University | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 3 | Netherlands |
| 11 | NCT03549663 (ClinicalTrials.gov) | July 4, 2018 | 10/5/2018 | Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN) | Random, Open, Control and Monocentric Clinical Research on Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN) | Idiopathic Membranous Nephropathy | Drug: Tacrolimus;Drug: Prednisone | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | NULL | Recruiting | 18 Years | 80 Years | All | 108 | N/A | China |
| 12 | NCT03466801 (ClinicalTrials.gov) | March 20, 2018 | 13/1/2018 | The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I. | The Efficacy of Prednisone Alone and Combination Therapy With Methylprednisolone and Cyclophosphamide in the Treatment of Membranous Nephropathy in Stage I. | Idiopathic Membranous Nephropathy | Drug: Prednisone;Drug: MP and CTX | Wenhu Liu | NULL | Terminated | 18 Years | 80 Years | All | 6 | N/A | China |
| 13 | ChiCTR1800014719 | 2018-02-01 | 2018-01-31 | A retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosis | A retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosis | idiopathic focal segmental glomerulosclerosis | tacrolimus group:nothing;prednisone group:nothing; | the First Affiliated Hospital of Third Military Medical University | NULL | Recruiting | Both | tacrolimus group:24;prednisone group:17; | China | |||
| 14 | ChiCTR1900027627 | 2017-12-01 | 2019-11-22 | Efficacy of leflunomide combined with prednisone for the treatment of PLA2R-associated primary membranous nephropathy | Efficacy of leflunomide combined with prednisone for the treatment of PLA2R-associated primary membranous nephropathy | f PLA2R-associated primary membranous nephropathy | experimental group:LEF combined with prednisone;control group:yclophosphamide (CTX) combined with prednisone; | Department of Nephrology, The First Affiliated Hospital of Bengbu Medical College | NULL | Completed | Both | experimental group:30;control group:30; | Phase 4 | China | ||
| 15 | NCT02921789 (ClinicalTrials.gov) | May 22, 2017 | 30/9/2016 | Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients | A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients | Kidney Transplantation;Primary Focal Segmental Glomerulosclerosis (FSGS) | Drug: Bleselumab;Drug: Basiliximab;Drug: Mycophenolate Mofetil (MMF);Drug: Tacrolimus Capsules;Drug: Methylprednisone;Drug: Prednisone | Astellas Pharma Global Development, Inc. | Kyowa Kirin Co., Ltd. | Completed | 18 Years | N/A | All | 67 | Phase 2 | United States;Canada |
| 16 | ChiCTR-TRC-11001454 | 2011-08-01 | 2011-08-08 | Tacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trial | Tacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trial | minimal change disease in adults;ICD10:N04.001 | Group A:Tacrolimus orally taken 0.5-1mg q12h for 36w, tape;Group B:prednisone orally taken for 36w, 1.0 mg/kg.d, tape; | Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University | NULL | Completed | Both | Group A:60;Group B:60; | China | |||
| 17 | ChiCTR-TQR-12002602 | 2009-10-09 | 2012-10-16 | The Effects of an Combinedative Treatment of with Prednisone plus and Fluvastatin on the Levels of Cholesterol and Bilirubin in the Patients with Minimal Change Nephropathy | The Effects of an Combinedative Treatment of with Prednisone plus and Fluvastatin on the Levels of Cholesterol and Bilirubin in the Patients with Minimal Change Nephropathy | Minimal change nephrotic syndrome in children | Treatment:prednisone 1~2 mg/kg/day+Fluvastatin Sodium Capsule;Control:prednisone 1~2 mg/kg/day; | Treatment center of kidney disease, 281th hospital of PLA | NULL | Completed | 4 | 12 | Both | Treatment:30;Control:30; | I (Phase 1 study) | China |
| 18 | NCT01197040 (ClinicalTrials.gov) | October 2009 | 7/9/2010 | Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome | Low Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome | Nephrotic Syndrome | Drug: Prednisone;Drug: acid mycophenolic (Myfortic) | Assistance Publique - Hôpitaux de Paris | Novartis | Completed | 18 Years | N/A | All | 117 | Phase 3 | France |
| 19 | NCT00956059 (ClinicalTrials.gov) | September 2009 | 10/8/2009 | Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis | Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis | Focal Segmental Glomerulosclerosis | Drug: prednisone, FK506, MMF;Drug: prednisone | Xi’an Jiaotong University College of Medicine | NULL | Not yet recruiting | 16 Years | 70 Years | Both | 40 | N/A | China |
| 20 | NCT00801463 (ClinicalTrials.gov) | January 2009 | 2/12/2008 | Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis | Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis | Proteinuria;Focal Segmental Glomerulosclerosis | Drug: tripterygium wilfordii (TW) | Nanjing University School of Medicine | NULL | Completed | 18 Years | 60 Years | Both | 67 | N/A | China |
| 21 | ChiCTR-TRC-08000098 | 2008-04-01 | 2008-04-14 | Reseaech on integrated therapy of traditional Chinese medicine for membranous nephropathy | Reseaech on integrated therapy of traditional Chinese medicine for membranous nephropathy | Idiopathic membranous nephropathy | Treatment group:Integrated therapy of TCM;Control group:Prednisone and CTX; | Longhua Hospital Affiliated to Shanghai University of TCM | NULL | Completed | 18 | 75 | Both | Treatment group:95;Control group:95; | I (Phase 1 study) | China |
| 22 | ChiCTR-TRC-10001024 | 2008-01-01 | 2010-09-14 | Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis | Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis | primary focal segmental glomerulosclerosis | group A:intravenous CTX 0.5-0.75g/m2 Monthly+Oral prednisone (Prednisolone) 0.8mg/kg.d ;group B:Oral FK506 FK506 0.1mg/kg.d+prednisone (Prednisolone) 0.5mg/kg.d ; | Shanghai Jiaotong University Affiliated Ruijin Hospital | NULL | Completed | 18 | 75 | Both | group A:30;group B:30; | China | |
| 23 | ChiCTR-OPN-17012789 | 2006-06-01 | 2017-09-25 | Glucocorticoids in the treatment of patients with primary focal segmental glomerulosclerosis and moderate proteinuria | Glucocorticoids in the treatment of patients with primary focal segmental glomerulosclerosis and moderate proteinuria | focal segmental glomerulosclerosis | study group:prednisone treatment;control group:ACEI/ARB; | Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | NULL | Completed | 17 | 80 | Both | study group:52;control group:50; | China | |
| 24 | NCT00362531 (ClinicalTrials.gov) | November 2004 | 9/8/2006 | Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome | Phase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome | Idiopathic Membranous Nephropathy;Nephrotic Syndrome | Drug: tacrolimus combined with prednisone | Peking University | NULL | Completed | 18 Years | 70 Years | Both | Phase 2/Phase 3 | NULL | |
| 25 | NCT00135967 (ClinicalTrials.gov) | May 2002 | 25/8/2005 | Mycophenolate Mofetil in Membranous Nephropathy | Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study | Glomerulonephritis, Membranous | Drug: mycophenolate mofetil orally 1000 mg twice a day (BID);Drug: prednisone 0,5 mg/kg orally on alternate days;Drug: intravenous (i.v.) methylprednisolone 1000 mg, total 9 | Radboud University | Hoffmann-La Roche | Completed | 18 Years | 75 Years | Both | 30 | Phase 2/Phase 3 | Netherlands |
224. 紫斑病性腎炎
臨床試験数 : 16 / 薬物数 : 43 - (DrugBank : 21) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 58
| 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 | ChiCTR2000039686 | 2020-12-01 | 2020-11-05 | To evaluate the efficacy and safety of tacrolimus in the treatment of children with Henoch Schonlein purpura nephritis | A multicentre, randomized, prospective, observational study evaluating the efficacy and safety of tacrolimus in the treatment of Henoch Schonlein purpura nephritis in children at 24 weeks | Henoch Schonlein purpura nephritis | Experimental drug treatment group:Tacroximus capsule (trade name: Saifu X R), 0.1mg /kg/d, orally taken 1 hour before or 2-3 hours after meals twice a day for 24 weeks;Prednisone 1.5-2mg/kg/d was taken orally for 4 weeks and then changed to oral administration every other day for 4 weeks, gradually reducing the amount.;Control treatment group:Cyclophosphamide 8-10mg/ kg/d was given intravenously for 2 consecutive days, once every 2-4 weeks for 4 consecutive times, and once every 3 weeks for 2 consecutive times for 6 times in total.Prednisone 1.5-2mg/kg/d was taken orally with breakfast in the morning. ; | Shengjing Hospital of China Medical University | NULL | Recruiting | Both | Experimental drug treatment group:156;Control treatment group:78; | Phase 4 | China | ||
| 2 | NCT03222687 (ClinicalTrials.gov) | September 1, 2015 | 7/7/2017 | Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis | Off-label Use of Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis: Effectiveness and Safety | Henoch-Schönlein Purpura Nephritis | Drug: tacrolimus;Drug: prednisone | Shandong University | NULL | Completed | N/A | 18 Years | All | 25 | Phase 4 | NULL |
| 3 | NCT02532790 (ClinicalTrials.gov) | August 2015 | 20/8/2015 | The Research of Standard Diagnosis and Treatment for HSPN With Mild Proteinuria in Children | The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis With Mild Proteinuria in Children | Henoch-Schoenlein Purpura Nephritis | Drug: Prednisone;Drug: ACEI | Nanjing Children's Hospital | NULL | Recruiting | 2 Years | 16 Years | All | 100 | Phase 2 | China |
| 4 | NCT02532777 (ClinicalTrials.gov) | August 2015 | 20/8/2015 | The Research of Standard Diagnosis and Treatment for HSPN in Children | The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children | Henoch-Schoenlein Purpura Nephritis | Drug: Prednisone;Drug: Cyclophosphamide(CTX);Drug: Mycophenolate mofetil(MMF);Drug: Leflunomide(LEF);Drug: Angiotensin-converting enzyme inhibitor(ACEI);Drug: Methylprednisolone | Nanjing Children's Hospital | NULL | Recruiting | 2 Years | 16 Years | All | 100 | Phase 2 | China |
| 5 | NCT03591471 (ClinicalTrials.gov) | September 2014 | 9/12/2014 | Study on Children Henoch-Schönlein Purpura Nephritis With TCM Multistep Treatment | Demonstrated Study on Children Henoch-Schönlein Purpura Nephritis With Multistep Treatment of Traditional Chinese Medicine Combined Disease and Syndrome Differentiation | Henoch-Schönlein Purpura Nephritis | Drug: Glycosides Of Tripterygium Wilfordii Hook(GTW);Drug: Sulfotanshinone Sodium Injection;Drug: Chinese herbs based on syndrome differentiation;Drug: Prednisone Acetate Tablets;Drug: Benazepril Hydrochloride Tablets;Drug: Low Molecular Weight Heparin Calcium Injection;Drug: Dipyridamole Tab 25 MG;Drug: Chinese medicine placebo | Henan University of Traditional Chinese Medicine | Peking University First Hospital;Children's Hospital of Fudan University;Shanghai Children's Hospital;Chengdu University of Traditional Chinese Medicine;Affiliated Hospital of Yunnan University of Traditional Chinese Medicine | Unknown status | 2 Years | 18 Years | All | 500 | Phase 1/Phase 2 | China |
228. 閉塞性細気管支炎
臨床試験数 : 97 / 薬物数 : 118 - (DrugBank : 32) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 156
| 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 | NCT01432080 (ClinicalTrials.gov) | September 2011 | 8/9/2011 | Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant | Does Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot Study | Respiratory Tract Infections;Bronchiolitis Obliterans;Cryptogenic Organizing Pneumonia;Lung Diseases, Interstitial | Drug: Prednisone;Drug: Azithromycin;Drug: Montelukast;Drug: Symbicort | Maisonneuve-Rosemont Hospital | The Canadian Blood and Marrow Transplant Group | Terminated | 18 Years | N/A | All | 12 | Phase 2 | Canada |
283. 後天性赤芽球癆
臨床試験数 : 19 / 薬物数 : 36 - (DrugBank : 23) / 標的遺伝子数 : 20 - 標的パスウェイ数 : 102
| 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 | NCT00006055 (ClinicalTrials.gov) | March 2000 | 5/7/2000 | Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases | Purpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu Arteritis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation | Fairview University Medical Center | NULL | Active, not recruiting | 1 Year | 55 Years | Both | 10 | N/A | United States |
284. ダイアモンド・ブラックファン貧血
臨床試験数 : 36 / 薬物数 : 95 - (DrugBank : 34) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 126
| 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 | NCT01464164 (ClinicalTrials.gov) | January 2012 | 31/10/2011 | Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan Anemia | Phase I/II, Open-Label Study to Determine Safety and Efficacy of Sotatercept (ACE-011) in Adults With Red Blood Cell Transfusion- Dependent Diamond Blackfan Anemia | Diamond Blackfan Anemia | Drug: Sotatercept;Drug: Sotatercept with prednisone boost | Northwell Health | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 1/Phase 2 | United States |
288. 自己免疫性後天性凝固因子欠乏症
臨床試験数 : 206 / 薬物数 : 231 - (DrugBank : 28) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 21
| 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 | NCT00306670 (ClinicalTrials.gov) | April 2006 | 23/3/2006 | Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Acquired Hemophilia A | A Prospective, Phase II/III Randomized, Mult-institutional Controlled, Open-label, Phase II Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Patients With Acquired Hemophilia A | Hemophilia A | Drug: Rituxan;Drug: prednisone | Georgetown University | Genentech, Inc. | Terminated | 18 Years | 65 Years | All | 2 | Phase 2/Phase 3 | United States |
299. 嚢胞性線維症
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| 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 | NCT03070522 (ClinicalTrials.gov) | May 1, 2017 | 8/2/2017 | Prednisone in Cystic Fibrosis Pulmonary Exacerbations | Randomized Controlled Trial of Prednisone in Cystic Fibrosis Pulmonary Exacerbations | Cystic Fibrosis Pulmonary Exacerbation | Drug: Prednisone;Drug: Placebos | The Hospital for Sick Children | Canadian Cystic Fibrosis Foundation | Recruiting | N/A | N/A | All | 84 | Phase 3 | Canada |
300. IgG4関連疾患
臨床試験数 : 40 / 薬物数 : 47 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141
| 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 | JPRN-jRCT2071210001 | 18/08/2021 | 01/04/2021 | A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease | A Phase 3, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease - VIB0551.P3.S2 | IgG4-Related Disease | RCP: Blinded treatment on Day 1, Day 15, and Week 26: - Inebilizumab group: Inebilizumab 300 mg intravenous (IV) - Placebo group: IV placebo Both groups: Oral prednisone (or equivalent) tablets from Day 1 to the end of Week 8 (tapering dose regimen: 2 weeks each at 20, 15, 10, and 5 mg/day of prednisone or equivalent, open-label, from commercial supply). Optional OLP: Open-label inebilizumab 300 mg IV on Day 1 and Week 26; blinded inebilizumab 300 mg or matching placebo on Day 15, depending on RCP treatment. | Katayama Sota | NULL | Recruiting | >= 20age old | Not applicable | Both | 16 | Phase 3 | USA;China;Australia;Canada;France;Italy;Germay;Hong Kong;Hungary;Israel;Ireland;Mexico;Netherlands;Poland;Argentina;Spain;UK;Turkey;Ukraine;Sweden;India;Japan |
| 2 | NCT04660565 (ClinicalTrials.gov) | January 2021 | 23/9/2020 | Belimumab Treatment for IgG4-related Disease | Belimumab Treatment for IgG4-related Disease, a Prospective, Open-label Clinical Trial | IgG4-related Disease | Drug: Prednisone and Belimumab;Drug: Prednisone | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 60 | Phase 4 | China |
| 3 | EUCTR2020-000417-33-IT (EUCTR) | 16/12/2020 | 21/10/2020 | Inebilizumab efficacy and safety in IgG4 related disease | A Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease(short title: MITIGATE – InebilizuMab effIcacy and safeTy in IGg4 relATed disEase) - MITIGATE | Immunoglobulin G4-related disease (IgG4-RD) MedDRA version: 20.0;Level: PT;Classification code 10077271;Term: Immunoglobulin G4 related disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Inebilizumab Product Code: [Inebilizumab] INN or Proposed INN: Inebilizumab Other descriptive name: afucosylated IgG1 kappa monoclonal antibody Trade Name: PREDNISONE DOC GENERICI - 5 MG COMPRESSE 30 COMPRESSE IN BLISTER PVC-PVDC/ALU Product Name: Prednisone Product Code: [Prednisone] INN or Proposed INN: PREDNISONE Trade Name: CETIRIZINA SANDOZ - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE IN BLISTER PVC/ALU Product Name: Cetirizina Product Code: [Cetirizina] INN or Proposed INN: CETIRIZINA Trade Name: PARACETAMOLO NOVA ARGENTIA - 500 MG COMPRESSE 20 COMPRESSE Product Name: Paracetamolo Product Code: [Paracetamolo] INN or Proposed INN: PARACETAMOLO Trade Name: METILPREDNISOLONE HIKMA - 1000 MG POLVERE PER SOLUZIONE INIETTABILE 10 FLACONCINI IN VETRO Product Name: Metilprednisolone Product Code: [Metilprednisolone] INN or Proposed INN: METILPREDNISOLONE | VIELABIO Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Ukraine;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Australia;Germany;Netherlands;China;Japan;Sweden;Korea, Republic of | ||
| 4 | NCT02703194 (ClinicalTrials.gov) | March 2016 | 27/2/2016 | Leflunomide for Maintenance of Remission in IgG4 Related Disease | A Study of Safety and Efficacy of Leflunomide for Maintenance of Remission in IgG4 Related Disease | Immunoglobulin G4 Related Sclerosing Disease | Drug: Prednisone;Drug: Leflunomide | Chinese PLA General Hospital | NULL | Completed | 18 Years | 80 Years | All | 68 | Phase 4 | China |
| 5 | NCT02458196 (ClinicalTrials.gov) | April 2015 | 15/4/2015 | Study of Treatment Response on IgG4 Related Disease (IgG4RD) | A Randomized Trial of Treatment in Patients With IgG4-Related Disease | Autoimmune Disease | Drug: Prednisone;Drug: Prednisone and Mycophenolate mofetil | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 70 Years | All | 60 | Phase 2 | China |
| 6 | NCT01758393 (ClinicalTrials.gov) | December 2012 | 24/12/2012 | Glucocorticoids in Patients With IgG4-RD | A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease | IgG4-related Disease | Drug: Prednisone | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 70 Years | Both | 40 | Phase 2/Phase 3 | China |
307. カナバン病
臨床試験数 : 6 / 薬物数 : 11 - (DrugBank : 5) / 標的遺伝子数 : 2 - 標的パスウェイ数 : 2
| 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 | NCT04833907 (ClinicalTrials.gov) | April 1, 2021 | 24/3/2021 | rAAV-Olig001-ASPA Gene Therapy for Treatment of Children With Typical Canavan Disease | Phase 1/2, Open Label, Sequential Cohort Study of a Single Intracranial Dose of AVASPA Gene Therapy for Treatment of Children With Typical Canavan Disease | Canavan Disease | Drug: rAAV-Olig001-ASPA;Drug: Levetiracetam;Drug: Prednisone | Myrtelle Inc. | NULL | Active, not recruiting | 3 Months | 60 Months | All | 24 | Phase 1/Phase 2 | United States |
331. 特発性多中心性キャッスルマン病
臨床試験数 : 33 / 薬物数 : 41 - (DrugBank : 21) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 123
| 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 | NCT03864419 (ClinicalTrials.gov) | October 24, 2019 | 1/3/2019 | Rituximab Hyaluronidase in Combination With Chemotherapy in Treating Aggressive B-cell Lymphoma in Uganda | A Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With Local Standard-of-Care Chemotherapy for the Treatment of Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma or as Monotherapy for Kaposi Sarcoma Herpesvirus Associated Multicentric Castleman Disease in Pediatrics and Adults in Uganda | Burkitt Lymphoma;KSHV-associated Multicentric Castleman Disease;Diffuse Large B-Cell Lymphoma | Biological: Rituximab and Hyaluronidase Human;Drug: Cyclophosphamide;Drug: Vincristine;Drug: Methotrexate;Drug: Doxorubicin;Drug: Doxorubicin Hydrochloride;Drug: Prednisone;Drug: Etoposide;Biological: Rituximab | Fred Hutchinson Cancer Center | NULL | Recruiting | 2 Years | N/A | All | 40 | Phase 1 | Uganda;United States |
| 2 | NCT03043105 (ClinicalTrials.gov) | January 1, 2017 | 31/1/2017 | TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot Trial | Thalidomide, Cyclophosphamide and Prednisone in Newly Diagnosed Multicentric Castleman's Disease: a Prospective, Single-center, Single-arm, Phase-II Pilot Trial | Multicentric Castleman Disease | Drug: Thalidomide, cyclophosphamide and prednisone | Peking Union Medical College Hospital | NULL | Active, not recruiting | 18 Years | N/A | All | 25 | Phase 2 | China |
| 3 | NCT02228512 (ClinicalTrials.gov) | August 15, 2014 | 27/8/2014 | Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas | Phase I/II Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas (Primary Effusion Lymphoma and Large Cell Lymphoma Arising in KSHV-Associated Multicentric Castleman Disease) | Large Cell Lymphoma Arising in KSHV-associated Multicentric Castleman Disease;Primary Effusion Lymphoma | Drug: Pomalidomide;Drug: Rituximab;Drug: Prednisone;Drug: Etoposide;Drug: Doxorubicin;Drug: Vincristine;Drug: Cyclophosphamide | National Cancer Institute (NCI) | NULL | Withdrawn | 18 Years | 99 Years | All | 0 | Phase 1/Phase 2 | United States |
| 4 | NCT00092222 (ClinicalTrials.gov) | October 28, 2004 | 21/9/2004 | Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity | Targeted Oncolytic Virotherapy and Natural History Study of KSHV-Associated Multicentric Castleman's Disease With Laboratory and Clinical Correlates of Disease Activity | Lymphoproliferative Disorder;HHV-8;Malignancy;HIV | Drug: Etoposide;Drug: Interferon-alpha;Drug: Rituximab;Drug: Zidovudine;Drug: Liposomal Doxorubicin;Drug: Bortezomib;Drug: Valganciclovir;Drug: Doxorubicin;Drug: Vincristine;Drug: Cyclophosphamide;Drug: Filgrastim (G-CSF);Drug: Prednisone;Drug: Sirolimus;Other: Observation Only | National Cancer Institute (NCI) | NULL | Active, not recruiting | 18 Years | N/A | All | 75 | Phase 2 | United States |