Corticosteroid ( DrugBank: - )
9 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 13 | Multiple sclerosis/Neuromyelitis optica | 8 |
| 42 | Polyarteritis nodosa | 1 |
| 43 | Microscopic polyangiitis | 3 |
| 44 | Wegener granulomatosis | 1 |
| 45 | Eosinophilic granulomatosis with Polyangiitis | 1 |
| 66 | IgA nephropathy | 7 |
| 96 | Crohn disease | 15 |
| 97 | Ulcerative colitis | 45 |
| 222 | Primary nephrotic syndrome | 9 |
13. Multiple sclerosis/Neuromyelitis optica
Clinical trials : 3,340 / Drugs : 2,163 - (DrugBank : 383) / Drug target genes : 241 - Drug target pathways : 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 | NCT04979650 (ClinicalTrials.gov) | May 22, 2021 | 2/7/2021 | Corticosteroid Effects on Asymptomatic Gadolinium-enhancing Lesions in Multiple Sclerosis | Corticosteroid Pulse Therapy Effects on MRI Asymptomatic Gadolinium-enhancing Lesions Conversion to a Non-enhancing Black Hole With or Without Treatment in MS Clinic of Booalisina Hospital Sari 2021-2023 | Multiple Sclerosis, Relapsing-Remitting;Magnetic Resonance Imaging;Methylprednisolone | Drug: Methylprednisolone succinate;Drug: Normal saline | Mazandaran University of Medical Sciences | NULL | Enrolling by invitation | 18 Years | 55 Years | All | 104 | Phase 2 | Iran, Islamic Republic of |
| 2 | NCT04660539 (ClinicalTrials.gov) | March 2, 2021 | 24/11/2020 | A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica Spectrum Disorder | Drug: satralizumab;Drug: azathioprine (AZA);Drug: mycophenolate mofetil (MMF);Drug: oral corticosteroids | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | N/A | All | 119 | Phase 3 | United States;Bulgaria;Canada;Croatia;Germany;Hungary;Italy;Japan;Korea, Republic of;Malaysia;Poland;Puerto Rico;Romania;Spain;Taiwan;Turkey;Ukraine;United Kingdom |
| 3 | NCT03752307 (ClinicalTrials.gov) | February 15, 2019 | 15/11/2018 | Safety and Tolerability of ISX (Isoxsuprine HCL) in MS Relapses | Double-blind, Placebo-controlled, Randomized Study of the Safety and Tolerability of Isoxsuprine HCL Combined With High Dose Steroid Treatment of Multiple Sclerosis (MS) Relapse | Multiple Sclerosis | Drug: Isoxsuprine Hydrochloride;Drug: Placebo;Drug: Corticosteroid | University of New Mexico | NULL | Completed | 18 Years | 50 Years | All | 2 | Phase 1/Phase 2 | United States |
| 4 | NCT03605238 (ClinicalTrials.gov) | August 15, 2018 | 29/6/2018 | Treatment of Relapsed and/or Refractory AQP4-IgG Seropositive NMOSD by Tandem CAR T Cells Targeting CD19 and CD20 | Clinical Study of CD19/CD20 tanCAR T Cells in Relapsed and/or Refractory AQP4-IgG Seropositive Neuromyelitis Optica Spectrum Disorders (NMOSD) | Neuromyelitis Optica Spectrum Disorder | Biological: Corticosteroids & tanCART19/20 | Chinese PLA General Hospital | NULL | Withdrawn | 12 Years | 75 Years | All | 0 | Phase 1 | China |
| 5 | NCT04450030 (ClinicalTrials.gov) | August 1, 2018 | 24/6/2020 | Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis | Immunoadsorption Versus High-dose Intravenous Corticosteroids in Relapsing Multiple Sclerosis - Assessment of Mechanism of Action | Multiple Sclerosis, Relapsing-Remitting | Drug: Methyl Prednisolonate;Procedure: Immunoadsorption | University Hospital Muenster | NULL | Active, not recruiting | 18 Years | 65 Years | All | 204 | Germany | |
| 6 | 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 |
| 7 | NCT02296346 (ClinicalTrials.gov) | October 2014 | 18/11/2014 | Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis | A Randomized, Controlled, Open-Label Study to Evaluate the Efficacy of Extracorporeal Photopheresis (ECP) Versus Corticosteroids in the Treatment of Patients With Secondary Progressive Multiple Sclerosis (SPMS) | Secondary Progressive Multiple Sclerosis | Drug: SoluMedrol;Device: Extracorporeal Photopheresis | University of Utah | Mallinckrodt | Terminated | 18 Years | 75 Years | All | 13 | N/A | United States |
| 8 | NCT00418145 (ClinicalTrials.gov) | September 2003 | 2/1/2007 | Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks | Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA) | Multiple Sclerosis | Drug: megadose oral methylprednisolone;Drug: IV methylprednisolone | Fred Lublin | National Multiple Sclerosis Society;Pfizer | Terminated | 18 Years | 50 Years | All | 16 | Phase 3 | United States |
42. Polyarteritis nodosa
Clinical trials : 15 / Drugs : 26 - (DrugBank : 16) / Drug target genes : 26 - Drug target pathways : 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 | NCT00647166 (ClinicalTrials.gov) | May 2008 | 26/3/2008 | Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) | Evaluation of a New Treatment Strategy for Patients With Microscopic Polyangiitis, Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) Without Poor Prognosis Factors | MPA;PAN or EGPA With FFS=0;At Diagnosis or Within the First 15 Days Following Initiation of Corticosteroids | Drug: corticosteroid and azathioprine;Drug: corticosteroid and placebo | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | Both | 114 | Phase 3 | France |
43. Microscopic polyangiitis
Clinical trials : 88 / Drugs : 81 - (DrugBank : 21) / Drug target genes : 15 - Drug target pathways : 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 | JPRN-UMIN000012072 | 2013/12/01 | 01/12/2013 | A prospective, open label, single arm, historical control trial of tocilizumab with corticosteroids in patients with microscopic polyangiitis | A prospective, open label, single arm, historical control trial of tocilizumab with corticosteroids in patients with microscopic polyangiitis - Tocilizumab with corticosteroids in microscopic polyangiitis | Microscopic polyangiitis | Tocilizumab group | Department of Rheumatology & Clinical Immunology Saitama Medical Center, Saitama Medical Universitity | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 20 | Phase 3 | Japan |
| 2 | NCT00647166 (ClinicalTrials.gov) | May 2008 | 26/3/2008 | Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) | Evaluation of a New Treatment Strategy for Patients With Microscopic Polyangiitis, Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) Without Poor Prognosis Factors | MPA;PAN or EGPA With FFS=0;At Diagnosis or Within the First 15 Days Following Initiation of Corticosteroids | Drug: corticosteroid and azathioprine;Drug: corticosteroid and placebo | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | Both | 114 | Phase 3 | France |
| 3 | NCT00307658 (ClinicalTrials.gov) | March 2001 | 27/3/2006 | Intravenous Immunoglobulin After Relapse in Vasculitis | Intravenous Immunoglobulin After Relapse in Vasculitis (Microscopic Polyangiitis, Wegener’s Granulomatosis and SHURG-STRAUSS Syndrome) During and After Corticosteroids and Immunosuppressant Therapies a Multicenter Prospective Trial | ANCA + Vasculitides Relapsing Either Under Corticosteroid;and Immunosuppressant Therapies or After One Year;Post Treatment. | Drug: Intravenous immunoglobulins (human immunoglobulins G) | Assistance Publique - Hôpitaux de Paris | NULL | Terminated | 18 Years | N/A | Both | 40 | Phase 3 | France |
44. Wegener granulomatosis
Clinical trials : 98 / Drugs : 108 - (DrugBank : 28) / Drug target genes : 22 - Drug target pathways : 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 | NCT00647166 (ClinicalTrials.gov) | May 2008 | 26/3/2008 | Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) | Evaluation of a New Treatment Strategy for Patients With Microscopic Polyangiitis, Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) Without Poor Prognosis Factors | MPA;PAN or EGPA With FFS=0;At Diagnosis or Within the First 15 Days Following Initiation of Corticosteroids | Drug: corticosteroid and azathioprine;Drug: corticosteroid and placebo | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | Both | 114 | Phase 3 | France |
45. Eosinophilic granulomatosis with Polyangiitis
Clinical trials : 31 / Drugs : 44 - (DrugBank : 18) / Drug target genes : 18 - Drug target pathways : 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 | NCT00647166 (ClinicalTrials.gov) | May 2008 | 26/3/2008 | Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) | Evaluation of a New Treatment Strategy for Patients With Microscopic Polyangiitis, Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) Without Poor Prognosis Factors | MPA;PAN or EGPA With FFS=0;At Diagnosis or Within the First 15 Days Following Initiation of Corticosteroids | Drug: corticosteroid and azathioprine;Drug: corticosteroid and placebo | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | Both | 114 | Phase 3 | France |
66. IgA nephropathy
Clinical trials : 275 / Drugs : 258 - (DrugBank : 82) / Drug target genes : 36 - Drug target pathways : 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 | EUCTR2021-005609-28-ES (EUCTR) | 18/03/2022 | 03/01/2022 | Study to assess whether the drug Ravulizumab works in patients with kidney problems due to IgA immunoglobulin and who do not respond to corticosteroids | A PILOT PROOF-OF–CONCEPT STUDY TO ASSESS THE EFFICACY AND SAFETY OF A 6 MONTHS RAVULIZUMAB TREATMENT IN PATIENTS WITH FLARES OF CORTICOSTEROID-RESISTANT IDIOPATHIC IgA NEPHROPATHY | Treatment for IgA nephropathy flares;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Ultomiris 300 mg/30 ml INN or Proposed INN: Ravulizumab Other descriptive name: ALXN1210 | Dr. Alfons Segarra Medrano | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1 | Phase 4 | Spain | ||
| 2 | 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 |
| 3 | NCT02981212 (ClinicalTrials.gov) | June 2016 | 24/11/2016 | Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid in Advanced IgA Nephropathy | Multi-center, Randomized, Open Label, Comparative, Phase IV Study to Evaluate the Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid for 48 Weeks in Advanced IgA Nephropathy | IgA Nephropathy | Drug: Mycophenolate Mofetil;Drug: ACE inhibitor;Drug: Corticosteroid;Drug: ARB | Yonsei University | Chong Kun Dang Pharmaceutical Corp.;Kyung Hee University Hospital at Gangdong;Kyungpook National University;Pusan National University Yangsan Hospital;Inje University;Seoul St. Mary's Hospital;Chonbuk National University Hospital | Recruiting | 19 Years | 65 Years | Both | 100 | Phase 4 | Korea, Republic of |
| 4 | NCT03015974 (ClinicalTrials.gov) | January 2016 | 3/1/2017 | Registry of IgA Nephropathy in Chinese Children | Registry of IgA Nephropathy in Chinese Children | IgA Nephropathy;Proteinuria in Nephrotic Range;Immunosuppressive Treatment | Drug: Corticosteroid;Drug: Cyclophosphamide;Drug: Mycophenolate mofetil;Drug: Dipyridamole;Drug: ACE Inhibitor or Angiotensin receptor antagonist | Peking University First Hospital | Nanjing PLA General Hospital;Beijing Children's Hospital;Central South University;The Children's Hospital of Zhejiang University School of Medicine;First Affiliated Hospital, Sun Yat-Sen University;Tongji Hospital;Hunan Children's Hospital;Shanghai Children's Hospital;Nanjing Children's Hospital;Children's Hospital of Chongqing Medical University;Shandong Provincial Hospital;Fuzhou General Hospital;Second Affiliated Hospital of Wenzhou Medical University;Children's Hospital of Hebei Province;Guangzhou Women and Children's Medical Center;Jiangxi Province Children's Hospital;Guangzhou First People's Hospital;Xian Children's Hospital;Capital Institute of Pediatrics, China;The First Hospital of Jilin University;Wuhan Women and Children's Medical Center;Tianjin Children's Hospital;Chengdu Women's and Children's Central Hospital;The First People's Hospital of Yunnan | Recruiting | 1 Month | 18 Years | All | 1200 | China | |
| 5 | NCT02571842 (ClinicalTrials.gov) | January 2012 | 6/10/2015 | Rituximab in Recurrent IgA Nephropathy | A Randomized, Prospective, Open-Label Study of Rituximab in the Treatment of Recurrent IgA Nephropathy With Active Endocapillary Proliferation Pathology | Recurrent IgA Nephropathy | Drug: Intravenous Rituximab;Drug: ACEI/ARB and corticosteroids | Chulalongkorn University | NULL | Recruiting | 18 Years | 70 Years | Both | 30 | Phase 4 | Thailand |
| 6 | NCT00755859 (ClinicalTrials.gov) | May 1998 | 18/9/2008 | Steroids and Azathioprine Versus Steroids Alone in IgAN | Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial. | IGA Nephropathy | Drug: steroids plus azathioprine;Drug: steroids | A. Manzoni Hospital | NULL | Completed | 16 Years | 70 Years | Both | 206 | Phase 4 | Italy;Switzerland |
| 7 | NCT00367562 (ClinicalTrials.gov) | January 1996 | 22/8/2006 | Inhibition of the Renin Angiotensin System Plus Corticosteroids for the Treatment of Proteinuria in IGA Nephropathy | Phase IV Open Label Uncontrolled Trial of the Dual Blockade of the Renin Angiotensin System With Enalapril Plus Valsartan Combined With Oral Methylprednisolone for the Treatment of Proteinuria in IGA Nephropathy | IGA Nephropathy | Drug: ENALAPRIL VALSARTAN METHYLPREDNISONE | Hospital Britanico | NULL | Completed | 21 Years | 70 Years | Both | 20 | Phase 4 | Argentina |
96. Crohn disease
Clinical trials : 2,442 / Drugs : 1,278 - (DrugBank : 248) / Drug target genes : 142 - Drug target pathways : 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 | NCT05542355 (ClinicalTrials.gov) | September 15, 2022 | 2/9/2022 | EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease | A Phase 1, Multicentre, 2-Part, Randomised, Parallel-arm, Placebo-controlled, Partially Double-blind Study to Evaluate the Safety and Target Engagement of EXL01 in the Maintenance of Steroid-induced Clinical Response or Remission in Participants With Mild to Moderate Crohn's Disease | Crohn Disease | Drug: EXL01;Drug: Placebo;Other: SoC corticosteroid - Induction Period;Other: SoC corticosteroid - Tapering | Exeliom Biosciences | Alimentiv Inc. | Recruiting | 18 Years | 75 Years | All | 67 | Phase 1 | Belgium;Poland |
| 2 | NCT05284136 (ClinicalTrials.gov) | April 1, 2022 | 28/2/2022 | Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease | Prospective rAndomized Controlled tRial of Crohn's diseAse Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease - PARADISE | Crohn Disease | Dietary Supplement: Crohn's disease exclusion diet (CDED);Drug: Oral prednisolone | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 16 Years | 70 Years | All | 80 | Phase 2/Phase 3 | France;Netherlands |
| 3 | NCT03905109 (ClinicalTrials.gov) | April 15, 2020 | 3/4/2019 | Safety Evaluation of ABX464 in Patients With Moderate to Severe Active Crohn's Disease | A Phase 2a, Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety of ABX464 Compared With Placebo in Patients With Moderate to Severe Active Crohn's Disease Who Have Inadequate Response, Loss of Response, or Intolerance to Prior Amino-salicylates, Immunosuppressant Treatment, Biologics, and/or Corticosteroid Treatment | Crohn Disease | Drug: ABX464;Drug: Placebo | Abivax S.A. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | Belgium |
| 4 | 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 |
| 5 | 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 |
| 6 | NCT02392286 (ClinicalTrials.gov) | March 2015 | 12/3/2015 | Corticosteroid Dosage for Crohn's Disease Flare | A Prospective, Randomized Trial Comparing the Efficacy of Body-weight Based Versus Fixed Corticosteroid Dosage on Remission in Patients With Moderate to Severe Crohn's Disease Flares | Crohn's Disease;Inflammatory Bowel Disease | Drug: Corticosteroid | Yale University | NULL | Terminated | 18 Years | N/A | All | 15 | Phase 4 | United States |
| 7 | NCT02056418 (ClinicalTrials.gov) | January 2014 | 24/1/2014 | Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult | A Randomized, Controlled, Single-blind Study of Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult | Crohn Disease | Dietary Supplement: enteral nutrition;Drug: corticosteroid | Jinling Hospital, China | NULL | Active, not recruiting | 18 Years | 75 Years | Both | 30 | Phase 4 | China |
| 8 | EUCTR2010-022017-26-GB (EUCTR) | 07/01/2011 | 08/12/2010 | A pilot study on the effects of an alternate-day corticosteroid regimen in children with active crohn’s disease - Alternate-day corticosteroid regimen in children with Crohn’s disease | A pilot study on the effects of an alternate-day corticosteroid regimen in children with active crohn’s disease - Alternate-day corticosteroid regimen in children with Crohn’s disease | Crohn's disease MedDRA version: 12.;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: Prednisolone INN or Proposed INN: Prednisolone | Central Manchester University Hospitals Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 27 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): | United Kingdom | ||
| 9 | NCT00672763 (ClinicalTrials.gov) | May 2008 | 2/5/2008 | Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (The IBDVit Study): Double-Blind, Placebo-Controlled Trial of Adjuvant Vitamin D (Colecalciferol) With Corticosteroids in Active Crohn's Disease | Crohn's Disease | Drug: Colecalciferol D3 (Vigantol Oil);Drug: Medium chain triglycerides | Imperial College London | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | United Kingdom |
| 10 | EUCTR2007-006692-37-GB (EUCTR) | 10/04/2008 | 25/01/2008 | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit | IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Vigantol Oel Product Name: Vigantol Oel TM | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 11 | EUCTR2006-003871-11-DE (EUCTR) | 06/02/2007 | 26/10/2006 | An open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR II | An open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR II | The trial aims to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). 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 | Germany | |||
| 12 | NCT00356408 (ClinicalTrials.gov) | January 2007 | 25/7/2006 | Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease | An Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752). | Crohn's Disease | Biological: Certolizumab pegol | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 106 | Phase 3 | United States;Canada;Germany |
| 13 | 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 | ||
| 14 | NCT00349752 (ClinicalTrials.gov) | November 2006 | 30/6/2006 | Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease | A Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease. | Crohn's Disease | Biological: certolizumab pegol 400 mg;Other: Placebo | UCB Pharma | NULL | Terminated | 18 Years | N/A | All | 174 | Phase 3 | United States;Canada;Germany;Belgium |
| 15 | NCT00056355 (ClinicalTrials.gov) | March 2003 | 10/3/2003 | Extracorporeal Photopheresis to Maintain Symptoms Remission During Steroid Withdrawal in Patients With Steroid-Dependent Crohn's Disease | A Single Arm Study of Extracorporeal Photoimmune Therapy With Uvadex For Corticosteroid Sparing in Patients With Corticosteroid-Dependent Crohn's Disease Who May Also Be Refractory or Intolerant to Immunosuppressants and/or Anti-Tumor Necrosis Factor Agen | Crohn Disease | Drug: UVADEX and UVAR XTS Photopheresis System | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | N/A | N/A | Both | 10 | Phase 1 | United States |
97. Ulcerative colitis
Clinical trials : 2,630 / Drugs : 1,459 - (DrugBank : 265) / Drug target genes : 144 - Drug target pathways : 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 | NCT05684484 (ClinicalTrials.gov) | February 1, 2023 | 26/12/2022 | Role of Roflumilast in Ulcerative Colitis | Clinical Study to Evaluate the Possible Efficacy and Safety of Roflumilast in Patients With Ulcerative Colitis. | Ulcerative Colitis | Drug: Roflumilast 500 Ug ORAL TABLET [Daliresp];Drug: corticosteroids +immune suppressive +amino salicylic acid | Tanta University | NULL | Not yet recruiting | 15 Years | 80 Years | All | 52 | Phase 4 | NULL |
| 2 | NCT04999228 (ClinicalTrials.gov) | November 1, 2021 | 5/8/2021 | Top Down Versus Step up in Pediatric Ulcerative Colitis | First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis | Ulcerative Colitis;Infliximab;Children | Drug: Infliximab;Drug: Corticosteroids | Children's Hospital of Fudan University | NULL | Recruiting | 6 Years | 18 Years | All | 40 | Phase 4 | China |
| 3 | NCT04879966 (ClinicalTrials.gov) | May 17, 2021 | 6/5/2021 | A Cohort Study Comparing IFX to CS for Moderate to Severe UC | A Multicenter Prospective Cohort Study Comparing Infliximab to Corticosteroids for Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis | Drug: Infliximab;Drug: Corticosteroid | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Recruiting | 18 Years | 70 Years | All | 342 | China | |
| 4 | EUCTR2018-003558-26-GB (EUCTR) | 11/02/2020 | 05/11/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - Investigate the safety and efficacy of study drug ABX464-103 | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 244 | Phase 2 | United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 5 | EUCTR2018-003558-26-FR (EUCTR) | 10/12/2019 | 08/02/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands | ||
| 6 | EUCTR2018-003558-26-DE (EUCTR) | 30/10/2019 | 15/03/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands | ||
| 7 | NCT03760003 (ClinicalTrials.gov) | September 23, 2019 | 29/11/2018 | Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis | A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-a] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment | Ulcerative Colitis | Drug: ABX464 25mg;Drug: ABX464 50mg;Drug: ABX464 100mg;Drug: Placebo | Abivax S.A. | NULL | Completed | 18 Years | 75 Years | All | 254 | Phase 2 | United States;Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom |
| 8 | EUCTR2018-003558-26-BE (EUCTR) | 29/08/2019 | 27/05/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | United States;Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 9 | EUCTR2018-003558-26-SI (EUCTR) | 12/06/2019 | 07/03/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 10 | EUCTR2018-003558-26-IT (EUCTR) | 11/06/2019 | 22/01/2021 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - ABX464-103 | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABX464 Product Code: [ABX464] Product Name: ABX464 Product Code: [ABX464] | Abivax | NULL | Not Recruiting | Female: yes Male: yes | 232 | Phase 2 | Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Germany;Netherlands | ||
| 11 | EUCTR2018-003558-26-SK (EUCTR) | 23/05/2019 | 20/03/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | Belarus;Serbia;United States;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 12 | EUCTR2018-003558-26-CZ (EUCTR) | 22/05/2019 | 14/03/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 232 | Phase 2 | Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;France;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy | ||
| 13 | EUCTR2018-003558-26-HU (EUCTR) | 21/05/2019 | 25/03/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 232 | Phase 2 | United States;Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany | ||
| 14 | EUCTR2018-003558-26-PL (EUCTR) | 20/05/2019 | 12/04/2019 | Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments. | A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. | Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | Belarus;Serbia;United States;Czechia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Germany | ||
| 15 | NCT03942861 (ClinicalTrials.gov) | February 21, 2019 | 25/4/2019 | Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. | Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. | Ulcerative Colitis;Ultrasound Therapy; Complications | Drug: Solu-Medrol | Copenhagen University Hospital at Herlev | NULL | Recruiting | 18 Years | 70 Years | All | 50 | Denmark | |
| 16 | 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 |
| 17 | EUCTR2017-000937-30-AT (EUCTR) | 22/02/2018 | 03/01/2018 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Spain;Poland;Belgium;Austria;Germany | ||
| 18 | ChiCTR2100043797 | 2018-01-01 | 2021-02-28 | The efficacy and mechanism of fecal microbiota transplantation in the treatment of patients with ulcerative colitis | The efficacy and mechanism of fecal microbiota transplantation in the treatment of patients with ulcerative colitis | Ulcerative colitis | Case series:Single or multiple FMT were performed via the working channel of the colonoscope or transendoscopic enteral tubing in 2 months. All patients were given concomitant oral mesalamine (4g/d) and patients who were taking corticosteroid did a mandatory taper of 2.5 mg per week until it was withdrawn.; | Department of Gastroenterology, Jinan Central Hospital | NULL | Completed | 21 | 81 | Both | Case series:28; | N/A | China |
| 19 | EUCTR2017-000937-30-PL (EUCTR) | 13/12/2017 | 25/09/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Spain;Belgium;Poland;Austria;Germany | ||
| 20 | EUCTR2017-000937-30-ES (EUCTR) | 27/11/2017 | 10/10/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Poland;Belgium;Spain;Austria;Germany | ||
| 21 | EUCTR2017-000937-30-FR (EUCTR) | 07/11/2017 | 19/09/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Spain;Poland;Belgium;Austria;Germany | ||
| 22 | EUCTR2016-001170-15-ES (EUCTR) | 19/10/2017 | 02/08/2017 | Intravenous corticosteroids in moderate ulcerative colitis | Efficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course in comparison with monotherapy oral corticosteroid course for moderate flares of ulcerative colitis: a randomized multicentre clinical trial - CECUM | Moderate flares of Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Urbason INN or Proposed INN: methylprednisolone Other descriptive name: METHYLPREDNISOLONE SODIUM HEMISUCCINATE | GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis ulcerosa) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 4 | Spain | ||
| 23 | EUCTR2017-000937-30-DE (EUCTR) | 10/10/2017 | 25/09/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Spain;Poland;Belgium;Austria;Germany | ||
| 24 | NCT03093259 (ClinicalTrials.gov) | October 1, 2017 | 17/3/2017 | ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis | Phase IIa Study to Evaluate the Safety and Efficacy of ABX464 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Immunomodulators, Anti-TNFa, Vedolizumab and/or Corticosteroids | Ulcerative Colitis | Drug: ABX464;Drug: Placebo oral capsule | Abivax S.A. | NULL | Completed | 18 Years | 70 Years | All | 32 | Phase 2 | Belgium |
| 25 | EUCTR2017-000937-30-BE (EUCTR) | 29/09/2017 | 03/08/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Spain;Poland;Belgium;Austria;Germany | ||
| 26 | NCT02425852 (ClinicalTrials.gov) | December 2016 | 21/4/2015 | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis | Ulcerative Colitis | Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: Hydrocortisone | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Recruiting | 18 Years | N/A | All | 146 | Phase 4 | France |
| 27 | NCT02665845 (ClinicalTrials.gov) | June 13, 2016 | 25/1/2016 | Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis). | Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis: A Protocol of a Multi-center Prospective Randomized Investigator Blinded Trial. | Ulcerative Colitis | Drug: 5-ASA;Drug: Corticosteroids | Centre Hospitalier Universitaire de Saint Etienne | NULL | Completed | 18 Years | N/A | All | 160 | Phase 3 | France;Greece;Israel;Italy;Korea, Republic of;Serbia |
| 28 | NCT04564638 (ClinicalTrials.gov) | March 1, 2015 | 11/9/2020 | Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids | Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids | Ulcerative Colitis | Drug: Corticosteroid | Tampere University Hospital | NULL | Completed | N/A | N/A | All | 217 | NULL | |
| 29 | NCT02033408 (ClinicalTrials.gov) | January 2014 | 3/12/2013 | Manipulating the Microbiome in IBD by Antibiotics and FMT | Manipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled Trial | Exacerbation of Ulcerative Colitis;Ulcerative Colitis, Active Severe;Crohn's Colitis | Drug: AB (antibiotics);Drug: CS (corticosteroids) Only | Shaare Zedek Medical Center | NULL | Completed | 2 Years | 75 Years | All | 28 | N/A | Canada;Finland;Israel;Italy;Poland;Spain |
| 30 | NCT01941589 (ClinicalTrials.gov) | September 2013 | 30/8/2013 | Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis | Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis. | Ulcerative Colitis | Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone;Drug: corticosteroids only | Sheba Medical Center | NULL | Completed | 18 Years | N/A | All | 149 | Phase 4 | China;France;Greece;Israel;Italy;Korea, Republic of;Serbia |
| 31 | NCT02922374 (ClinicalTrials.gov) | January 2013 | 28/9/2016 | Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis | Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational Study | Acute Severe Colitis (ASC) | Drug: corticosteroids | Jinling Hospital, China | NULL | Active, not recruiting | 18 Years | N/A | Both | 117 | Phase 1/Phase 2 | China |
| 32 | NCT01536535 (ClinicalTrials.gov) | July 10, 2012 | 16/2/2012 | Predicting Response to Standardized Pediatric Colitis Therapy | Multicenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis. | Ulcerative Colitis | Drug: Mesalazine;Drug: IV Corticosteroid;Drug: Oral Corticosteroids;Other: Additional Therapies;Procedure: Colectomy | Connecticut Children's Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 4 Years | 17 Years | All | 431 | Phase 4 | United States;Canada |
| 33 | EUCTR2009-015077-12-GB (EUCTR) | 23/11/2009 | 17/09/2009 | The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia | The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia | chronic ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Budenofalk 2mg rectal foam Product Name: Budenofalk rectal foam | University Hospital Birmingham NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 34 | EUCTR2006-003607-40-BE (EUCTR) | 09/12/2008 | 27/10/2008 | A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN CORTICOSTEROID-DEPENDENT ULCERATIVE COLITIS - METEOR | A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN CORTICOSTEROID-DEPENDENT ULCERATIVE COLITIS - METEOR | Steroid-dependent ulcerative colitis | Trade Name: methotrexate bellon Product Name: methotrexate bellon 25mg/ml INN or Proposed INN: methotrexate bellon 25mg/ml | Besancon University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Finland;Belgium;Austria;Netherlands | |||
| 35 | EUCTR2007-006692-37-GB (EUCTR) | 10/04/2008 | 25/01/2008 | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit | IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Vigantol Oel Product Name: Vigantol Oel TM | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 36 | NCT00498589 (ClinicalTrials.gov) | September 2007 | 9/7/2007 | Comparison of Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis | A Controlled, Randomized, Double-blind, Multicenter Study, Comparing Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis | Ulcerative Colitis | Drug: methotrexate;Drug: placebo | Centre Hospitalier Universitaire de Besancon | NULL | Completed | 18 Years | 75 Years | Both | 110 | Phase 2 | Austria;Belgium;France;Israel;Italy;Netherlands |
| 37 | EUCTR2006-004303-19-BE (EUCTR) | 08/06/2007 | 07/02/2007 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Czech Republic;United Kingdom;Belgium | |||
| 38 | EUCTR2006-004303-19-CZ (EUCTR) | 09/05/2007 | 20/02/2007 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 181 | United Kingdom;Czech Republic;Belgium | |||
| 39 | EUCTR2006-004303-19-SK (EUCTR) | 04/05/2007 | 08/03/2007 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 181 | Phase 2 | Czech Republic;Slovakia;Belgium;United Kingdom | ||
| 40 | EUCTR2006-004303-19-GB (EUCTR) | 25/04/2007 | 06/12/2006 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Czech Republic;Slovakia;Belgium;United Kingdom | ||
| 41 | NCT00430898 (ClinicalTrials.gov) | January 2007 | 31/1/2007 | Basiliximab in Moderate to Severe Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: Basiliximab | Cerimon Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | Both | 181 | Phase 2 | United States;Belgium;Czech Republic;India;Poland;Russian Federation;Slovakia;Ukraine;United Kingdom |
| 42 | NCT00269438 (ClinicalTrials.gov) | December 2005 | 22/12/2005 | New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis | Phase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of Therapy | Ulcerative Colitis | Drug: 5 ASA, enemas, suppositories, corticosteroids | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 80 Years | All | 225 | Phase 3 | United States |
| 43 | NCT00267306 (ClinicalTrials.gov) | January 2004 | 16/12/2005 | Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis | A Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous Corticosteroids | Severe Ulcerative Colitis | Drug: Visilizumab | Facet Biotech | PDL BioPharma, Inc. | Completed | 16 Years | 70 Years | Both | 144 | Phase 1/Phase 2 | United States |
| 44 | NCT00259545 (ClinicalTrials.gov) | February 2003 | 25/11/2005 | Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis | Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden | Ulcerative Colitis;Phosphatidylcholine | Drug: Retarded Release Phosphatidylcholine (rPC) | Heidelberg University | Professor Wolfgang Stremmel;Dietmar Hopp Stiftung | Completed | 16 Years | 90 Years | Both | 60 | Phase 2 | Germany |
| 45 | NCT00032305 (ClinicalTrials.gov) | March 2002 | 14/3/2002 | Research Study in Patients With Severe Ulcerative Colitis | A Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids | Ulcerative Colitis | Drug: Visilizumab | Facet Biotech | NULL | Completed | 18 Years | 70 Years | Both | 20 | Phase 2/Phase 3 | United States |
222. Primary nephrotic syndrome
Clinical trials : 310 / Drugs : 295 - (DrugBank : 117) / Drug target genes : 63 - Drug target pathways : 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 | 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 |
| 2 | NCT05679336 (ClinicalTrials.gov) | May 1, 2018 | 28/11/2022 | Rituximab, Cyclophosphamide, and Corticosteroids in Primary Membranous Nephropathy | Rituximab, Cyclophosphamide, and Corticosteroids at Low Cumulative Doses to Induce Remission in Primary Membranous Nephropathy | Membranous Nephropathy - PLA2R Induced | Drug: Rituximab, Cyclophosphamide, and Corticosteroids | St. Petersburg State Pavlov Medical University | NULL | Recruiting | 18 Years | 75 Years | All | 40 | N/A | Russian Federation |
| 3 | 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 |
| 4 | NCT00354731 (ClinicalTrials.gov) | August 2006 | 18/7/2006 | Efficacy of Pentoxifylline on Primary Nephrotic Syndrome | Clinical Efficacy of Pentoxifylline on Patients With Primary Nephrotic Syndrome | Nephrotic Syndrome | Drug: pentoxifylline;Drug: Corticosteroid | National Taiwan University Hospital | National Science Council, Taiwan | Completed | 20 Years | 80 Years | Both | 62 | Phase 3 | Taiwan |
| 5 | EUCTR2005-004460-22-BE (EUCTR) | 12/05/2006 | 05/12/2005 | Multicenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to corticosteroids with ACE-inhibitors in the treatment of de novo nephrotic syndrome due to focal segmental glomerulosclerosis. | Multicenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to corticosteroids with ACE-inhibitors in the treatment of de novo nephrotic syndrome due to focal segmental glomerulosclerosis. | focal and segmental glomerulosclerosis | Trade Name: Neoral Product Name: Neoral Trade Name: Medrol Product Name: Medrol Trade Name: zestril Product Name: zestril | Hopital Erasme | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Belgium | |||
| 6 | JPRN-UMIN000004653 | 2005/01/01 | 02/12/2010 | The clinical effects and safty of cyclosporine with rootine corticosteroid treatment in onset MCNS | The clinical effects and safty of cyclosporine with rootine corticosteroid treatment in onset MCNS - The effects of cyclosporine in onset MCNS | minimal change nephrotic syndrome | cyclosporine A 2-3mg/kg/day | Yokohama city university graduate school of medicine | NULL | Complete: follow-up continuing | 16years-old | Not applicable | Male and Female | 20 | Not applicable | Japan |
| 7 | ChiCTR1900022518 | 2004-04-01 | 2019-04-15 | Clinical trial for corticosteroids monotherapy in the treatment of seronegative hepatitis B virus-associated membranous nephropathy. | Efficacy and safety of corticosteroids in 26 cases of seronegative hepatitis B virus-associated membranous nephropathy | Seronegative Hepatitis B Virus-associated Membranous Nephropathy | Case series:give corticosteroids(Methylprednisolone); | Tianjin Hospital | NULL | Completed | Both | Case series:26; | China | |||
| 8 | NCT00404833 (ClinicalTrials.gov) | January 2003 | 27/11/2006 | Mycophenolate Mofetil in Membranous Nephropathy and Focal Segmental | A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Conventional Immunosuppressive Treatment on Proteinuria in Idiopathic Membranous Nephropathy (MN) and Focal Segmental Glomerulosclerosis (FSGS) | Glomerulonephritis, Membranous;Glomerulosclerosis, Focal | Drug: prednisolone and mycophenolate mofetil;Drug: prednisolone and chlorambucil | Hospital Authority, Hong Kong | The University of Hong Kong | Completed | 18 Years | 65 Years | Both | 16 | Phase 3 | China |
| 9 | EUCTR2015-001039-18-Outside-EU/EEA (EUCTR) | 03/07/2015 | Trial on the therapeutic effect of Tacrolimus in combination with low dosage corticosteroids compared with high dosage corticosteroids only, in patients with minimal change necrotic syndrome | Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf [Cap.]®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) - T_OPTIMUM study | Minimal change nephrotic syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prograf INN or Proposed INN: TACROLIMUS Trade Name: Prograf INN or Proposed INN: TACROLIMUS Trade Name: Solondo INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Solondo INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE | Astellas Pharma Korea, Inc. | NULL | NA | Female: yes Male: yes | 152 | Korea, Republic of |