49. 全身性エリテマトーデス ［臨床試験数：429，薬物数：477（DrugBank：150），標的遺伝子数：110，標的パスウェイ数：185］
Searched query = "Systemic lupus erythematosus"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04060888 | January 3, 2020 | 22 October 2019 | A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Chinese Subjects With Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 milligram (mg);Drug: Placebo | Janssen Research & Development, LLC | Not recruiting | 18 Years | 75 Years | All | 190 | Phase 3 | China | |
| 2 | NCT04127747 | December 1, 2019 | 4 November 2019 | Efficacy of Individualized Rituximab in Maintaining Remission of Moderate and Severe Systemic Lupus Erythematosus | A Multicenter, Randomized Controlled Clinical Study About Efficacy and Safety of Standard Dose and Individualized Dose of Rituximab in Maintaining Remission in Patients With Moderate to Severe Systemic Lupus Erythematosus | Autoimmune Diseases | Drug: Standard dose of rituximab;Drug: Individualized dose of rituximab | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not recruiting | 18 Years | 65 Years | All | 86 | Phase 4 | ||
| 3 | NCT04058028 | October 31, 2019 | 28 October 2019 | Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) | A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy | Systemic Lupus Erythematosus (SLE) | Drug: AMG 570;Drug: Placebo for AMG 570 | Amgen | Not recruiting | 18 Years | 75 Years | All | 300 | Phase 2 | ||
| 4 | NCT04136145 | October 28, 2019 | 11 November 2019 | Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects | An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the PK and Safety of Belimumab 200 mg Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Participants | Systemic Lupus Erythematosus | Drug: Belimumab for IV;Drug: Belimumab for SC | GlaxoSmithKline | Recruiting | 18 Years | 45 Years | All | 36 | Phase 1 | China | |
| 5 | NCT04128579 | October 1, 2019 | 28 October 2019 | Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis | A Phase 1b Randomized, Double-blind, Placebo-controlled, Multiple Ascending-dose Study of EQ001 in Subjects With Systemic Lupus Erythematosus With or Without Active Proliferative Lupus Nephritis | Lupus Erythematosus;Lupus Nephritis | Drug: Itolizumab [Bmab 600];Drug: EQ001 Placebo | Equillium | Biocon Limited | Recruiting | 18 Years | 75 Years | All | 56 | Phase 1 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT04077684 | September 10, 2019 | 16 September 2019 | Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial | Efficacy and Safety of Low-dose Interleukin-2 in Patients With Systemic Lupus Erythematosus: a Multicenter, Randomised, Placebo-controlled Trial | Systemic Lupus Erythematosus | Drug: Interleukin-2 | Peking University People's Hospital | Not recruiting | 18 Years | 75 Years | All | 500 | Phase 2 | ||
| 7 | NCT03843125 | September 9, 2019 | 11 November 2019 | A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Baricitinib | Eli Lilly and Company | Incyte Corporation | Recruiting | 18 Years | N/A | All | 1100 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Chile;China;Colombia;Czechia;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Switzerland;Taiwan;United Kingdom |
| 8 | ChiCTR1900025376 | 2019-09-01 | 27 August 2019 | Lenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial | Lenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial | systemic lupus erythematosus | intervention group:lenalidomide 10mg qd;control group:placebo 10mg qd; | Chinese Academy of Medical Sciences Peking Union Medical College Hospital | Recruiting | 18 | 70 | Both | intervention group:15;control group:15; | Phase 4 | China | |
| 9 | NCT03953261 | September 1, 2019 | 26 August 2019 | Effect of Curcumin on Systemic Lupus Erythematosus | Effect of Curcumin on Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Dietary Supplement: Curcumin supplement | Loma Linda University | Not recruiting | 18 Years | N/A | All | 68 | Phase 2 | ||
| 10 | NCT04082416 | September 2019 | 30 September 2019 | Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) | A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: RC18 160 mg plus standard therapy | RemeGen | Recruiting | 18 Years | 65 Years | All | 318 | Phase 3 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT03978520 | July 25, 2019 | 4 November 2019 | A Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus | A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Drug: ABBV-105;Drug: Placebo for ABBV-105;Drug: Upadacitinib;Drug: Placebo for upadacitinib | AbbVie | Recruiting | 18 Years | 65 Years | All | 310 | Phase 2 | United States;Argentina;Australia;Canada;China;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;New Zealand;Poland;Puerto Rico;Spain;Taiwan;United Kingdom | |
| 12 | NCT03951259 | July 24, 2019 | 16 September 2019 | Safety and Efficacy of SM934 Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus | A Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of SM934 in Adult Subjects With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: SM934;Drug: Placebos | RenJi Hospital | Jiangsu ZuoYou Medicine Co., Ltd. | Recruiting | 18 Years | 70 Years | All | 48 | Phase 2 | China |
| 13 | NCT03656627 | June 27, 2019 | 22 October 2019 | Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Autoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative Colitis | Drug: Nivolumab | Alliance Foundation Trials, LLC. | Bristol-Myers Squibb | Recruiting | 18 Years | N/A | All | 72 | Phase 1 | United States |
| 14 | ChiCTR1900022934 | 2019-06-20 | 5 May 2019 | 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 | Not Recruiting | Both | Experimental group:20;control group:20;healthy control group:20; | Phase 1 | China | |||
| 15 | NCT03804723 | June 2019 | 28 January 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 | Not recruiting | 18 Years | 85 Years | All | 321 | N/A | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT03933943 | May 21, 2019 | 22 October 2019 | A Study of LY3361237 in Participants With Systemic Lupus Erythematosus | A Phase 1, Randomized, Placebo-Controlled, Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: LY3361237;Drug: Placebo | Eli Lilly and Company | Recruiting | 18 Years | 70 Years | All | 24 | Phase 1 | United States | |
| 17 | NCT03949426 | May 1, 2019 | 11 November 2019 | Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects | A First-in-Human, Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Dose Study in Healthy Participants to Evaluate the Safety, Tolerability and Pharmacokinetics of KPG-818 | Systemic Lupus Erythematosus | Drug: KPG-818 | Kangpu Biopharmaceuticals, Ltd. | Not recruiting | 18 Years | 55 Years | All | 40 | Phase 1 | United States | |
| 18 | NCT03845517 | April 18, 2019 | 11 November 2019 | A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: PF-06700841 15 mg;Drug: PF-06700841 30 mg;Drug: PF-06700841 45 mg | Pfizer | Recruiting | 18 Years | 75 Years | All | 448 | Phase 2 | United States;Bulgaria;Canada;Hungary;Japan;Korea, Republic of;Poland;Romania;Taiwan | |
| 19 | NCT03816345 | April 4, 2019 | 11 November 2019 | Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable Cancer | A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) | Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Neoplasm | Biological: Nivolumab | National Cancer Institute (NCI) | Recruiting | 18 Years | N/A | All | 264 | Phase 1 | United States | |
| 20 | NCT03917797 | April 2, 2019 | 29 April 2019 | Mesenchymal Stromal Cells (MSC´s) in Renal Lupus | Dose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Renal Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic;Lupus Glomerulonephritis | Biological: MSC treatment;Drug: Standard of Care;Drug: Placebo | Universidad de los Andes, Chile | Recruiting | 18 Years | 75 Years | All | 39 | Phase 2 | Chile | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT03920267 | March 26, 2019 | 27 May 2019 | Long-Term Safety and Efficacy Study of BMS-986165 in Participants With Systemic Lupus Erythematosus | A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: BMS-986165 | Bristol-Myers Squibb | Recruiting | 18 Years | 75 Years | All | 360 | Phase 2 | United States;Hungary;Japan;Korea, Republic of;Poland;Romania;Russian Federation;Taiwan | |
| 22 | NCT03771885 | March 16, 2019 | 18 March 2019 | BI 705564 in Patients With Systemic Lupus Erythematosus (SLE) | A Phase Ib, Multicentre, Randomised, Double-blind, Placebo Controlled, 8 Week Crossover Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered BI 705564 in Patients With Systemic Lupus Erythematosus. | Lupus Erythematosus, Systemic | Drug: BI 705564;Drug: Placebo | Boehringer Ingelheim | Not recruiting | 18 Years | N/A | All | 0 | Phase 1 | ||
| 23 | ChiCTR1900020803 | 2019-03-01 | 28 January 2019 | Efficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trial | Efficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trial | systemic lupus erythematosus | intervention group:melatonin 6mg qn;control group:placebo qn; | Chinese Academy of Medical Sciences Peking Union Medical College Hospital | Not Recruiting | 18 | 65 | Both | intervention group:88;control group:88; | Post-market | China | |
| 24 | EUCTR2018-000305-23-HU | 07/02/2019 | 28 February 2019 | No | A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care | 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] - Skin and Connective Tissue Diseases [C17] | Product Name: BOS161721 Product Code: BOS161721 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not known CAS Number: 2229685-51-0 Current Sponsor code: BOS161721 Other descriptive name: IMMUNOGLOBULIN G Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50 - Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Boston Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 156 | Phase 2 | United States;Philippines;Hungary;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Georgia;Bulgaria;Colombia | |||
| 25 | ChiCTR1800020286 | 2019-02-01 | 14 January 2019 | 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 | Not Recruiting | Both | Group 2:40;Group 1:20; | Phase 1 study | China | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT03742037 | December 21, 2018 | 4 November 2019 | Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Cenerimod 0.5 mg;Drug: Cenerimod 1 mg;Drug: Cenerimod 2 mg;Drug: Cenerimod 4 mg;Drug: Placebo | Idorsia Pharmaceuticals Ltd. | Recruiting | 18 Years | 75 Years | All | 500 | Phase 2 | United States;Bulgaria;Czechia;France;Georgia;Germany;Hungary;Israel;Italy;Mexico;Poland;Russian Federation;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Lithuania;Romania | |
| 27 | NCT03618056 | December 19, 2018 | 4 November 2019 | Evaluating HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus | A Phase 1b Open Label Clinical Trial to Evaluate HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus | HIV Infections;Systemic Lupus Erythematosus | Biological: AIDSVAX® B/E | National Institute of Allergy and Infectious Diseases (NIAID) | Not recruiting | 18 Years | 50 Years | All | 16 | Phase 1 | United States | |
| 28 | NCT03656562 | December 19, 2018 | 4 November 2019 | Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients | A Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) | Drug: VAY736;Drug: VAY736 Placebo;Drug: CFZ533;Drug: CFZ533 Placebo | Novartis Pharmaceuticals | Recruiting | 18 Years | 75 Years | All | 120 | Phase 2 | Argentina;Australia;Czechia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan;Thailand | |
| 29 | NCT03817424 | December 13, 2018 | 30 September 2019 | A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis | A Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis | Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;Dermatomyositis | Drug: VIB7734;Drug: Placebo | Viela Bio | Recruiting | 18 Years | 75 Years | All | 32 | Phase 1 | United States;Poland;Spain | |
| 30 | EUCTR2018-001508-12-ES | 12/12/2018 | 28 February 2019 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) 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] | Product Code: VAY736 Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: ianalumab Current Sponsor code: VAY736 Other descriptive name: VAY736 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Concentrate for solution for injection/infusion Route of administration of the placebo: Subcutaneous use Product Code: CFZ533 Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: iscalimab Current Sponsor code: CFZ533 Other descriptive name: CFZ533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Concentrate for solution for injection/infusion Route of administration of the placebo: Intravenous use | Novartis Farmacéutica, S.A. | Authorised | Female: yes Male: yes | 120 | Phase 2 | Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT02525835 | December 1, 2018 | 1 October 2018 | Tissue Sodium in Autoimmune Disease | Tissue Sodium in Autoimmune Disease | Systemic Lupus Erythematosus | Dietary Supplement: Low Dietary Sodium;Dietary Supplement: High Dietary Sodium | Vanderbilt University | Not recruiting | 18 Years | N/A | All | 0 | N/A | United States | |
| 32 | NCT03878303 | November 28, 2018 | 25 March 2019 | Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE) | A Phase 1b Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Pharmacokinetics and Pharmacodynamics of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: AC0058TA;Drug: Placebo AC0058TA | ACEA Therapeutics, Inc. | Hangzhou ACEA Pharmaceutical Research Co., Ltd. | Recruiting | 18 Years | 75 Years | All | 32 | Phase 1 | United States |
| 33 | NCT03724916 | November 26, 2018 | 11 November 2019 | A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE) | A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;Lupus Erythematosus, Systemic | Drug: TAK-079;Drug: TAK-079 Placebo | Millennium Pharmaceuticals, Inc. | Recruiting | 18 Years | 75 Years | All | 24 | Phase 1 | United States | |
| 34 | ChiCTR1800019308 | 2018-11-12 | 19 November 2018 | Efficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosus | Efficacy and tolerability of multitarget therapy with NHMX for systemic lupus erythematosus | systemic lupus erythematosus | NHMX:One kind of non-steroid anti-inflammatory drugs combines with hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine (maintaining the drug concentration between 30-90ug/l);control:hydroxychloroquine sulfate(=200mg/bid) and methotrexate(7.5-20mg/w), with addition of glucocorticoid (=0.5mg/kg·d) or cyclosporine(maintaining the drug concentration between 30-90ug/l); | The Third Affiliated Hospital, Southern Medical University | Recruiting | 18 | 65 | Both | NHMX:75;control:75; | Other | China | |
| 35 | EUCTR2018-001508-12-DE | 12/11/2018 | 19 November 2018 | Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) | Systemic lupus erythematosus (SLE) 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] | Product Code: VAY736 Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: ianalumab Current Sponsor code: VAY736 Other descriptive name: VAY736 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Concentrate for solution for injection/infusion Route of administration of the placebo: Subcutaneous use Product Code: CFZ533 Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: iscalimab Current Sponsor code: CFZ533 Other descriptive name: CFZ533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Concentrate for solution for injection/infusion Route of administration of the placebo: Intravenous use | Novartis Pharma AG | Authorised | Female: yes Male: yes | 120 | Phase 2 | Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT02633163 | October 26, 2018 | 8 April 2019 | Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE) | A Phase II Controlled Trial of Allogeneic Mesenchymal Stem Cells for the Treatment of Refractory Lupus | Systemic Lupus Erythematosus | Drug: Low Dose Mesenchymal Stem Cells (MSCs);Drug: High Dose Mesenchymal Stem Cells (MSCs);Drug: Placebo Infusion | Medical University of South Carolina | Recruiting | 18 Years | 65 Years | All | 81 | Phase 2 | United States | |
| 37 | NCT03626311 | October 23, 2018 | 22 July 2019 | Omega-3 Replacement With Krill Oil in Disease Management of SLE | A Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Health Benefit After 24 Weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids From Krill), Followed by a 24 Week Open-Label Extension, in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) | Dietary Supplement: AKBM-3031;Other: Placebo | Aker Biomarine Antarctic AS | Ampel BioSolutions, LLC | Recruiting | 18 Years | N/A | All | 76 | N/A | United States;Canada |
| 38 | NCT03747159 | October 1, 2018 | 10 December 2018 | Synergetic B-cell Immunomodulation in SLE - 2nd Study. | A Randomized Trial to Investigate the Reset of Humoral Autoimmunity by Combining Belimumab With Rituximab in Severe Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Belimumab Injection | Leiden University Medical Center | Dutch Kidney Foundation;GlaxoSmithKline | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | Netherlands |
| 39 | EUCTR2018-001392-21-NL | 25/09/2018 | 15 October 2018 | Synergetic B-cell immunomodulation in SLE – 2nd study | A randomized trial to investigate the reset of humoral autoimmunity by combining belimumab with rituximab in severe systemic lupus erythematosus | systemic lupus erythematosus MedDRA version: 20.0 Level: LLT Classification code 10042947 Term: Systemic lupus erythematosus synd System Organ Class: 100000004859 MedDRA version: 20.0 Level: LLT Classification code 10029142 Term: Nephritis systemic lupus erythematosus System Organ Class: 100000004857 MedDRA version: 20.0 Level: LLT Classification code 10042948 Term: Systemic lupus erythematosus syndrome aggravated System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: belimumab or benlysta Pharmaceutical Form: Solution for solution for injection Trade Name: anti-CD20 B cell depletion with Truxima Product Name: truxima Pharmaceutical Form: Concentrate for emulsion for infusion | Leiden University Medical Center | Authorised | Female: yes Male: yes | 30 | Phase 2 | Netherlands | |||
| 40 | NCT03575156 | September 20, 2018 | 9 October 2018 | Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis | Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis | Systemic Lupus Erythematosus;Systemic Scleroderma | Biological: blood sample;Biological: urine sample | University Hospital, Bordeaux | Recruiting | 18 Years | N/A | All | 200 | N/A | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT03527472 | August 23, 2018 | 22 October 2019 | Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus | A Randomized Placebo-controlled, Double Blind Phase 2 Clinical Trial of Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Memantine;Drug: Placebo | Vanderbilt University Medical Center | Kleberg Foundation | Recruiting | 18 Years | 60 Years | All | 144 | Phase 2 | United States |
| 42 | JPRN-JapicCTI-183973 | 16/8/2018 | 16 July 2019 | A Study of Ustekinumab in Participants with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Intervention name : Ustekinumab INN of the intervention : Ustekinumab Dosage And administration of the intervention : Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160 Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160. | Janssen Pharmaceutical K.K. | Recruiting | 16 | 75 | BOTH | 500 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Africa | |
| 43 | NCT03616912 | August 2, 2018 | 11 November 2019 | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | Incyte Corporation | Recruiting | 18 Years | N/A | All | 750 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;China;Croatia;Czechia;Germany;Greece;Hungary;Israel;Mexico;Netherlands;Russian Federation;Switzerland;Taiwan;United Kingdom;Ukraine |
| 44 | NCT03616964 | August 2, 2018 | 11 November 2019 | A Study of Baricitinib in Participants With Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | Incyte Corporation | Recruiting | 18 Years | N/A | All | 750 | Phase 3 | United States;Argentina;Chile;Colombia;France;India;Italy;Japan;Korea, Republic of;Philippines;Poland;Romania;Serbia;South Africa;Spain |
| 45 | ChiCTR1800017540 | 2018-08-01 | 20 August 2018 | 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:prednisone;2:Mycophenolate Mofetil; | Ruijin Hospital | Recruiting | 18 | 65 | Both | 1:50;2:50; | Other | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT03562065 | July 1, 2018 | 2 July 2018 | Treatment of Refractory Systemic Lupus Erythematosus by Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord | Treatment of Refractory Systemic Lupus Erythematosus by Injection of Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord | Lupus Erythematosus;Stem Cell Transplant | Biological: mesenchymal stem cells | Assistance Publique - Hôpitaux de Paris | Not recruiting | 18 Years | 70 Years | All | 10 | Phase 1/Phase 2 | France | |
| 47 | EUCTR2017-001489-53-HU | 14/06/2018 | 25 June 2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | 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: Stelara Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: Stelara Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Janssen-Cilag International NV | Authorised | Female: yes Male: yes | 500 | Phase 3 | Serbia;United States;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Peru;Australia;South Africa;Bulgaria;Germany;Japan;China;Korea, Republic of | |||
| 48 | EUCTR2017-001489-53-ES | 12/06/2018 | 18 June 2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | 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: Stelara Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: Stelara Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Janssen-Cilag International NV | Authorised | Female: yes Male: yes | 500 | Phase 3 | Serbia;United States;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Peru;Australia;South Africa;Bulgaria;Germany;Japan;China;Korea, Republic of | |||
| 49 | NCT03541564 | May 30, 2018 | 9 October 2018 | An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects | A Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy Subjects | Systemic Lupus Erythematosus;Healthy Participants | Drug: BMS-986165;Drug: Moxifloxacin;Other: Placebo | Bristol-Myers Squibb | Not recruiting | 18 Years | 50 Years | All | 84 | Phase 1 | United States | |
| 50 | EUCTR2017-001764-37-PT | 14/05/2018 | 21 May 2018 | An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | 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] | Product Name: GDC-0853 Product Code: RO7010939/F13 Pharmaceutical Form: Tablet INN or Proposed INN: not available yet CAS Number: 1434048-34-6 Current Sponsor code: GDC-0853, RO7010939 Other descriptive name: GDC-0853 RO7010939 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Genentech, Inc. | Authorised | Female: yes Male: yes | 240 | Phase 2 | Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | EUCTR2017-001489-53-DE | 08/05/2018 | 23 July 2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | 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: Stelara Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: Stelara Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Janssen-Cilag International NV | Authorised | Female: yes Male: yes | 500 | Phase 3 | Serbia;United States;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Peru;Australia;South Africa;Bulgaria;Germany;Japan;China;Korea, Republic of | |||
| 52 | EUCTR2017-001489-53-LT | 07/05/2018 | 5 June 2018 | Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS | 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: Stelara Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: Stelara Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Janssen-Cilag International NV | Authorised | Female: yes Male: yes | 500 | Phase 3 | Serbia;United States;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Peru;Australia;South Africa;Bulgaria;Germany;Japan;China;Korea, Republic of | |||
| 53 | NCT03312335 | May 1, 2018 | 11 June 2018 | Low-dose Interleukin-2 for Treatment of Systemic Lupus Erythematosus | Open-label, Monocentric, Phase II, Investigator-initiated Clinical Trial on Unbiased Characterization of Immunological Parameters in Interleukin-2-treated Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Low-dose Aldesleukin (Proleukin®) | Onur Boyman, MD | Recruiting | 18 Years | N/A | All | 16 | Phase 2 | Switzerland | |
| 54 | NCT03556007 | May 1, 2018 | 22 October 2019 | A Study of NKTR-358 in Participants With Systemic Lupus Erythematosis (SLE) | A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous NKTR-358 in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: NKTR-358;Drug: Placebo | Nektar Therapeutics | Eli Lilly and Company | Not recruiting | 18 Years | 70 Years | All | 48 | Phase 1 | United States |
| 55 | NCT03492255 | April 12, 2018 | 6 May 2019 | 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 | Recruiting | 18 Years | N/A | All | 232 | N/A | Brazil |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT03451422 | April 10, 2018 | 4 November 2019 | Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus | A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy | Systemic Lupus Erythematosus | Drug: AMG 592;Drug: Placebo | Amgen | Recruiting | 18 Years | 70 Years | All | 132 | Phase 1/Phase 2 | United States;France;Germany;Poland | |
| 57 | EUCTR2017-001400-29-FR | 16/03/2018 | 20 August 2018 | Treatment of systemic lupus erythematosus by injection iv of mesenchymal stem cells (MSC-LES) | Treatment of severe refractory systemic lupus erythematosus by injection of allogeneic mesenchymal stem cells derived from the umbilical cord - MSC SLE - MSC-LES | Treatment of Systemic Lupus Erythematosus refractory to standard treatments. 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] | Product Name: ALLOGENEIC MESENCHYMAL STROMAL CELLS DERIVED FROM THE UMBILICAL CORD Product Code: 0 Pharmaceutical Form: Suspension for injection INN or Proposed INN: 0 CAS Number: 0 Current Sponsor code: P150302 Other descriptive name: CSM allogéniques issues de cordons ombilicaux ( MTI-PP) Concentration unit: 1X 100 milligrams/millilitre Concentration type: range Concentration number: 1.106-4.106 | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | Authorised | Female: yes Male: yes | 10 | Phase 1;Phase 2 | France | |||
| 58 | EUCTR2017-004060-35-HU | 12/03/2018 | 30 April 2019 | An open-label study to evaluate the safety and tolerability of 200-mcg Dose of IPP-201101 in Patients With SLE | An open-label study of the safety and tolerability of repeated administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | 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: Body processes [G] - Immune system processes [G12] | Product Name: IPP-201101 Product Code: IPP-201101 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: IPP-201101 Current Sponsor code: IPP-201101 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- | ImmuPharma | Not Recruiting | Female: yes Male: yes | 75 | Phase 3 | United States;Hungary;Mauritius | |||
| 59 | NCT03393013 | March 7, 2018 | 26 August 2019 | A Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis | A Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis | Systemic Lupus Erythematosus;Lupus Nephritis | Drug: KZR-616;Drug: Placebo | Kezar Life Sciences, Inc. | Recruiting | 18 Years | 75 Years | All | 72 | Phase 1/Phase 2 | United States;Australia;Colombia;Mexico | |
| 60 | ChiCTR1800015030 | 2018-03-01 | 5 March 2018 | A Clinical Trial on Safety and effect of Dapagliflozin to Control Blood Glucose Levels in Systemic Lupus Erythematosus | The Safety of SGLT2-i Dapagliflozin on Treating Blood Glucose Levels in SLE | Systemic Lupus Erythematosus | Case series:add-on or replace dapagliflozin; | Dept. Rheumatology, Renji Hospital South Campus | Not Recruiting | 18 | 70 | Both | Case series:35; | Phase 4 study | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT03312907 | March 1, 2018 | 11 November 2019 | A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steriod Taper | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 280 | Phase 3 | United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain | |
| 62 | NCT03480529 | March 1, 2018 | 16 September 2019 | Monitoring the IMmUological TOXicity of Drugs | Monitoring the IMmUological TOXicity of Drugs | Arthritis;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Capillary Leak Syndrome;Hepatitis | Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom | Groupe Hospitalier Pitie-Salpetriere | Institut National de la Santé Et de la Recherche Médicale, France | Not recruiting | 18 Years | N/A | All | 662 | Early Phase 1 | France |
| 63 | NCT03396393 | March 2018 | 29 January 2018 | Exploratory Study of DHA in Systemic Lupus Erythematosus Patients | A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics and Efficacy of Dihydroartemisinin Tablets in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Dihydroartemisinin tablet;Drug: Placebo tablet | Kunming Pharmaceuticals, Inc. | Not recruiting | 18 Years | 65 Years | All | 120 | Phase 2 | ||
| 64 | NCT03427151 | February 27, 2018 | 23 April 2019 | Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | An Open-label Study of the Safety and Tolerability of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: IPP-201101 | ImmuPharma | Not recruiting | 18 Years | N/A | All | 62 | Phase 3 | United States;Czechia;France;Germany;Hungary;Mauritius;Puerto Rico;Poland | |
| 65 | NCT03371251 | February 7, 2018 | 11 February 2019 | Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care | A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care | Systemic Lupus Erythematosus | Drug: BOS161721;Drug: Placebo | Boston Pharmaceuticals | Recruiting | 18 Years | 70 Years | All | 186 | Phase 1/Phase 2 | United States;Argentina;Bulgaria;Colombia;Georgia;Hungary;Mexico;Peru;Philippines;Poland;Romania;Ukraine | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | NCT03370263 | January 15, 2018 | 29 July 2019 | BENLYSTA® Special Drug Use Investigation | BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation | Systemic Lupus Erythematosus | Drug: Benlysta | GlaxoSmithKline | Recruiting | N/A | N/A | All | 600 | Phase 2/Phase 3 | Japan | |
| 67 | EUCTR2016-003050-32-DE | 09/01/2018 | 7 January 2019 | A Phase 3 Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo- Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) or Lupus 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: MabThera (Rituximab) Product Name: MabThera (Rituximab) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: BELIMUMAB CAS Number: 356547-88-1 Current Sponsor code: GSK1550188 Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 200- | GlaxoSmithKline Research & Development Ltd | Authorised | Female: yes Male: yes | 280 | Phase 3 | United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Netherlands;Germany;Korea, Republic of | |||
| 68 | NCT03407482 | January 9, 2018 | 11 November 2019 | An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus | A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: GDC-0853 | Genentech, Inc. | Not recruiting | 18 Years | 76 Years | All | 160 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Korea, Republic of;Mexico;Spain;Taiwan;United Kingdom;Germany;Portugal | |
| 69 | NCT03030118 | December 28, 2017 | 15 July 2019 | Study of Anti-Malarials in Incomplete Lupus Erythematosus | Study of Anti-Malarials in Incomplete Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Hydroxychloroquine;Drug: Placebo Oral Capsule | Milton S. Hershey Medical Center | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Recruiting | 15 Years | 45 Years | All | 240 | Phase 2 | United States |
| 70 | NCT03093402 | December 21, 2017 | 14 October 2019 | JBT-101 in Systemic Lupus Erythematosus (SLE) | A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus (ALE09) | Systemic Lupus Erythematosus;SLE;Lupus | Drug: JBT-101;Drug: Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Corbus Pharmaceuticals Inc.;Autoimmunity Centers of Excellence | Recruiting | 18 Years | 70 Years | All | 100 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | EUCTR2017-001764-37-BG | 15/12/2017 | 19 March 2018 | An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | 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] | Product Name: GDC-0853 Product Code: RO7010939/F13 Pharmaceutical Form: Tablet INN or Proposed INN: not available yet CAS Number: 1434048-34-6 Current Sponsor code: GDC-0853, RO7010939 Other descriptive name: GDC-0853 RO7010939 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Genentech, Inc. | Authorised | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | |||
| 72 | EUCTR2016-003050-32-ES | 05/12/2017 | 26 March 2018 | A Phase 3 Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo- Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus (SLE) or Lupus 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: MabThera (Rituximab) Product Name: MabThera (Rituximab) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: BELIMUMAB CAS Number: 356547-88-1 Current Sponsor code: GSK1550188 Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 200- | GlaxoSmithKline, S.A. | Authorised | Female: yes Male: yes | 200 | Phase 3 | United States;Mexico;Canada;Argentina;Brazil;Spain;Russian Federation;South Africa;Netherlands;Korea, Republic of | |||
| 73 | NCT03334851 | November 17, 2017 | 30 September 2019 | Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis | A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS | Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: PF-06835375;Drug: Placebo | Pfizer | Recruiting | 18 Years | 70 Years | All | 112 | Phase 1 | United States | |
| 74 | EUCTR2017-001764-37-ES | 07/11/2017 | 11 December 2017 | An Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | 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] | Product Name: GDC-0853 Product Code: RO7010939/F13 Pharmaceutical Form: Tablet INN or Proposed INN: not available yet CAS Number: 1434048-34-6 Current Sponsor code: GDC-0853, RO7010939 Other descriptive name: GDC-0853 RO7010939 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Roche Farma, S.A por delegación de Genentech, Inc. | Authorised | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | |||
| 75 | ChiCTR-IOR-17012802 | 2017-09-26 | 2 October 2017 | Synergy effects and health regulation effect of oxygen-ozone therapy on systemic lupus erythematosus (SLE) | Synergy effects and health regulation effect of oxygen-ozone therapy on systemic lupus erythematosus (SLE) | systemic lupus erythematosus (SLE) | the Controled Group:basic oral therapy;the Treated Group:basic oral therapy + Autologous blood transfusion with oxygen-ozone + acupoint injection with oxygen-ozone on ST 36; | Guangdong Provincial Hospital of Chinese Medicine | Recruiting | 18 | 65 | Both | the Controled Group:30;the Treated Group:30; | Other | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | NCT03054259 | September 21, 2017 | 13 May 2019 | Rituximab Objective Outcome Measures Trial in SLE | A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus | Systemic Lupus Erythematosus Arthritis | Drug: Rituximab;Drug: Methylprednisolone;Drug: Normal Saline | University of Leeds | Recruiting | 18 Years | 99 Years | All | 30 | Phase 2 | United Kingdom | |
| 77 | NCT03254784 | September 13, 2017 | 11 February 2019 | A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation | A Phase 1, Randomized, Open-Label, Single-Dose, Crossover Study To Evaluate the Bioavailability of BMS-986165 Tablet Formulation Relative To BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal And Increased Gastric pH on the Bioavailability of BMS-986165 Tablet Formulation in Healthy Subjects | Systemic Lupus Erythematosus;Arthritic Psoriasis;Psoriasis;Inflammatory Bowel Diseases | Drug: BMS-986165 Capsule;Drug: BMS-986165 Tablet | Bristol-Myers Squibb | Not recruiting | 18 Years | 50 Years | All | 49 | Phase 1 | United States;Netherlands | |
| 78 | NCT03098823 | September 12, 2017 | 18 December 2018 | 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 | Not recruiting | 18 Years | 99 Years | All | 62 | Phase 4 | United States | |
| 79 | NCT03252587 | September 1, 2017 | 4 November 2019 | An Investigational Study to Evaluate BMS-986165 in Patients With Systemic Lupus Erythematosus | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: BMS-986165;Other: Placebo | Bristol-Myers Squibb | Recruiting | 18 Years | 75 Years | All | 360 | Phase 2 | United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Taiwan;Ukraine | |
| 80 | NCT03262727 | September 1, 2017 | 11 June 2018 | The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients | The Effect of BMS-986165 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects | Systemic Lupus Erythematosus;Arthritic Psoriasis;Psoriasis;Inflammatory Bowel Diseases | Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol);Drug: BMS-986165 | Bristol-Myers Squibb | Not recruiting | 18 Years | 40 Years | Female | 49 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | NCT03260166 | August 31, 2017 | 16 December 2017 | Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus Erythematosus | An Open-label Study for Assessing the Efficacy and Safety of Nicotinamide Treatment for Lupus-associated Skin Lesions in Patients With Cutaneous Lupus Erythematosus or Systemic Lupus Erythematosus | Cutaneous Lupus Erythematosus;Systemic Lupus Erythematosus Rash | Drug: nicotinamide | Second Xiangya Hospital of Central South University | National Natural Science Foundation of China;Hunan Provincial Natural Science Foundation of China;National Key Clinical Specialty Construction Project of China | Recruiting | 18 Years | 65 Years | All | 40 | Phase 2 | China |
| 82 | NCT03288324 | August 23, 2017 | 26 August 2019 | Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus | A 3-part Open-label Study Assessing Safety, Tolerability, Pharmacokinetic and -Dynamic Profiles, and Efficacy of Tofacitinib in Young Adults From Age 18 to 45 With Moderate to Severe Skin Involvement Due to Lupus | Cutaneous Lupus;Systemic Lupus Erythematosus | Drug: Tofacitinib | Children's Hospital Medical Center, Cincinnati | Pfizer | Recruiting | 18 Years | 45 Years | All | 20 | Phase 1/Phase 2 | United States |
| 83 | NCT03219801 | August 1, 2017 | 16 December 2017 | Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus Erythematosus | Evaluation of Safety and Efficacy in Patients With Systemic Lupus Erythematosus by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells | Systemic Lupus Erythematosus | Biological: mesenchymal stem cells | Hebei Medical University | Not recruiting | 14 Years | 60 Years | All | 10 | Early Phase 1 | China | |
| 84 | NCT03189017 | July 3, 2017 | 26 August 2019 | A Phase I Study of ICP-022 in Healthy Subjects | A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating Dose | Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: ICP-022;Drug: Placebos | Innocare Pharma Australia Pty Ltd | Not recruiting | 18 Years | 55 Years | Male | 64 | Phase 1 | Australia | |
| 85 | NCT02920424 | June 30, 2017 | 16 December 2017 | A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: JNJ-56022473;Drug: Placebo | Janssen Research & Development, LLC | Not recruiting | 18 Years | 65 Years | All | 0 | Phase 1 | Germany | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | EUCTR2016-002950-19-DE | 19/06/2017 | 28 February 2019 | A Phase II Study of M2951 in SLE | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A | Systemic Lupus Erythematosus (SLE) 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] | Product Name: Evobrutinib Product Code: M2951 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Evobrutinib CAS Number: 1415823-73-2 Current Sponsor code: M2951 Other descriptive name: M2951 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Merck KGaA | Not Recruiting | Female: yes Male: yes | 468 | Phase 2 | United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of | |||
| 87 | EUCTR2016-004574-17-ES | 08/06/2017 | 3 July 2017 | A study to measure how safe CC-220 is and how well CC-220 works in people with lupus. | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 19.1 Level: LLT Classification code 10025134 Term: Lupus erythematosus System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CC-220 Pharmaceutical Form: Capsule, hard INN or Proposed INN: CC-220 Other descriptive name: CC-220 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.15- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Code: CC-220 Pharmaceutical Form: Capsule, hard INN or Proposed INN: CC-220 Other descriptive name: CC-220 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.3- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Code: CC-220 Pharmaceutical Form: Capsule, hard INN or Proposed INN: CC-220 Other descriptive name: CC-220 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.45- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Celgene Corporation | Authorised | Female: yes Male: yes | 280 | Phase 2 | Germany;Poland;Brazil;Belgium;Argentina;Canada;Mexico;Hungary;Italy;Colombia;Russian Federation;Spain;United States;Serbia | |||
| 88 | NCT03122431 | June 5, 2017 | 11 June 2018 | Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases | Relevance of Monitoring Blood Levels Compared to Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases: Adherence and Understanding the Possible Underlying Mechanisms Involved in Effectiveness and in Adverse Effects | Systemic Lupus Erythematosus (SLE);Juvenile SLE;Cutaneous Lupus | Drug: Thalidomide;Drug: Hydroxychloroquine reduced;Drug: Hydroxychloroquine high | University of Sao Paulo General Hospital | Fundação de Amparo à Pesquisa do Estado de São Paulo | Recruiting | 5 Years | 64 Years | All | 296 | Phase 4 | Brazil |
| 89 | ChiCTR-INC-17011497 | 2017-05-25 | 5 June 2017 | The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of moderate to severe activity systemic lupus erythematosus | The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of moderate to severe activity systemic lupus erythematosus | moderate to severe active systemic lupus erythematosus | Immunomodulation combined with traditional DMARDS treatment group:Immunomodulation combined with traditional DMARDS group: On the basis of glucocorticoid and traditional DMARDS treatment, metformin hydrochloride tablets 250mg, 3 times / day, oral; atorvastatin tablets 10mg, 1 times / day; in the first 4 weeks , 12 weeks and 24 weeks to assess the SELSNA-SLEDAI score table,traditional DMARDS treatment group:Traditional DMARDS treatment group: the use of glucocorticoid and traditional DMARDS treatment. 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.; | The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology | Not Recruiting | Both | Immunomodulation combined with traditional DMARDS treatment group:60;traditional DMARDS treatment group:60; | New Treatment Measure Clinical Study | China | |||
| 90 | ChiCTR-INR-17011495 | 2017-05-25 | 5 June 2017 | The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic systemic lupus erythematosus | 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 | 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; | New Treatment Measure Clinical Study | China | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 91 | EUCTR2016-000625-39-BG | 17/05/2017 | 28 February 2019 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | 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] | Product Name: Anifrolumab Product Code: MEDI-546 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Anifrolumab CAS Number: 1326232-46-5 Current Sponsor code: MEDI 546 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | AstraZeneca AB | Authorised | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand | |||
| 92 | NCT03125486 | May 17, 2017 | 12 March 2018 | Compassionate Use for Subcutaneous (SC) Belimumab | Compassionate Use for Subcutaneous (SC) Belimumab | Systemic Lupus Erythematosus | Drug: SC belimumab 200 mg | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | N/A | United States | ||
| 93 | NCT03171194 | April 27, 2017 | 13 May 2019 | Pilot Trial of Mesenchymal Stem Cells for Systemic Lupus Erythematosus | A Phase I Safety Trial of Allogeneic Mesenchymal Stem Cells for Systemic Lupus Erythematosus | System; Lupus Erythematosus | Drug: Low Dose Mesenchymal Stem Cells (MSCs) | Medical University of South Carolina | Not recruiting | 18 Years | 65 Years | All | 6 | Phase 1 | United States | |
| 94 | JPRN-JapicCTI-173544 | 26/4/2017 | 16 July 2019 | TULIP SLE LTE | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Intervention name : Anifrolumab INN of the intervention : anifrolumab Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses | AstraZeneca | Not Recruiting | 18 | BOTH | 50 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania | ||
| 95 | NCT03355482 | April 10, 2017 | 16 December 2017 | MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE | MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE | Systemic Lupus Erythematosus Arthritis | Drug: Methylprednisolone;Drug: Placebos | Oklahoma Medical Research Foundation | Bristol-Myers Squibb | Recruiting | 18 Years | 70 Years | All | 40 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 96 | NCT03159936 | April 3, 2017 | 17 June 2019 | Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) | Open Label Phase 2 Pilot Trial of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) | Discoid Lupus Erythematosus;Systemic Lupus Erythematosus | Biological: Tofacitinib citrate | Tufts Medical Center | Pfizer | Recruiting | 18 Years | 65 Years | All | 12 | Early Phase 1 | United States |
| 97 | NCT03042260 | March 1, 2017 | 11 March 2019 | Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous | Prophylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled Trial | Lupus Erythematosus, Systemic | Drug: Trimethoprim-Sulfamethoxazole;Drug: Placebo Oral Tablet | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | National Council of Science and Technology, Mexico | Recruiting | 18 Years | N/A | All | 310 | Phase 4 | Mexico |
| 98 | NCT03030976 | March 2017 | 16 December 2017 | A Study of CD19 Redirected Autologous T Cells for CD19 Positive Systemic Lupus Erythematosus (SLE) | An Open-labeled, Uncontrolled, Single-arm Pilot Study to Evaluate Cellular Immunotherapy Using CD19-targeted Chimeric Antigen Receptor Engineered T Cells in Patients With CD19+ B Cell Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) | Drug: cyclophosphamide;Drug: anti-CD19-CAR-T cells | Shanghai GeneChem Co., Ltd. | RenJi Hospital | Recruiting | 18 Years | 69 Years | All | 5 | Phase 1 | China |
| 99 | NCT02962960 | February 14, 2017 | 28 January 2019 | A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Following Subcutaneous Administration in Adult Systemic Lupus Erythematosus Subjects With Type I Interferon Test High Result and Active Skin Manifestations. | Systemic Lupus Erythematosus | Drug: Anifrolumab;Drug: Placebo | AstraZeneca | Not recruiting | 18 Years | 70 Years | All | 36 | Phase 2 | United States;Hungary;Korea, Republic of;Poland | |
| 100 | EUCTR2016-003246-93-PL | 26/01/2017 | 11 June 2018 | The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms. | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations | Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 Pharmaceutical Form: Solution for injection INN or Proposed INN: ANIFROLUMAB CAS Number: 1326232-46-5 Current Sponsor code: MEDI-546 Other descriptive name: Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Astrazeneca AB | Authorised | Female: yes Male: yes | 32 | Phase 2 | United States;Hungary;Poland;Korea, Republic of | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 101 | NCT02880852 | January 23, 2017 | 19 November 2018 | Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus | A Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1550188 in Chinese Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Belimumab | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 20 | Phase 1 | China | |
| 102 | NCT02908100 | January 19, 2017 | 14 October 2019 | Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus | A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: GDC-0853 (high dose);Drug: GDC-0853 (low dose);Drug: Placebo | Genentech, Inc. | Not recruiting | 18 Years | 75 Years | All | 254 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Germany;Korea, Republic of;Mexico;Portugal;Spain;Taiwan;United Kingdom;France;Thailand | |
| 103 | NCT02955615 | January 18, 2017 | 18 March 2019 | ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE) | A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: ILT-101;Drug: Placebo | Iltoo Pharma | Not recruiting | 18 Years | N/A | All | 100 | Phase 2 | Austria;Bulgaria;France;Germany;Italy;Mauritius;Mexico;Portugal;Romania;Spain | |
| 104 | NCT02975336 | January 4, 2017 | 11 November 2019 | A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE) | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: M2951 | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Not recruiting | 18 Years | 75 Years | All | 480 | Phase 2 | United States;Argentina;Bulgaria;Chile;Colombia;Germany;Italy;Japan;Korea, Republic of;Malaysia;Mauritius;Mexico;Peru;Philippines;Poland;Romania;Russian Federation;South Africa;Taiwan |
| 105 | EUCTR2016-003246-93-HU | 06/12/2016 | 30 April 2019 | The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms. | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations | Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anifrolumab Product Code: MEDI-546 Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Astrazeneca AB | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | United States;Hungary;Poland;Korea, Republic of | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 106 | EUCTR2016-001039-11-GB | 16/11/2016 | 30 April 2018 | A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus | A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | 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] | Product Name: GDC-0853 Product Code: RO7010939/F13 Pharmaceutical Form: Tablet INN or Proposed INN: not available yet CAS Number: 1434048-34-6 Current Sponsor code: GDC-0853, RO7010939 Other descriptive name: GDC-0853 RO7010939 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Genentech, Inc. | Authorised | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of | |||
| 107 | ChiCTR-IPR-16009451 | 2016-11-01 | 18 April 2017 | The Efficacy and Safety of Low Dose IL-2 Conbined Rapamycin Therapy in Chinese Over-treated Patients with Systemic Lupus Erythematosus | The Efficacy and Safety of Low Dose IL-2 Conbined Rapamycin Therapy in Chinese Over-treated Patients with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | IL-2 group:IL-2;IL-2 + Rapamycin group :IL-2 and Rapamycin;non IL-2 or IL-6 antagonist group :Glucocorticoids and DMARDs; | the Second Hospital of Shanxi Medical University | Not Recruiting | 18 | 80 | Both | IL-2 group:20;IL-2 + Rapamycin group :20;non IL-2 or IL-6 antagonist group :20; | Post-market | China | |
| 108 | NCT02847598 | October 20, 2016 | 4 November 2019 | Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE) | A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations | Systemic Lupus Erythematosus;Active Cutaneous Lupus Erythematosus | Drug: BIIB059;Drug: Placebo | Biogen | Not recruiting | 18 Years | 75 Years | All | 264 | Phase 2 | United States;Argentina;Bulgaria;Colombia;Israel;Korea, Republic of;Mexico;Philippines;Poland;Serbia;Taiwan;Thailand | |
| 109 | NCT02953821 | October 13, 2016 | 22 October 2019 | Acthar Gel for Active Systemic Lupus Erythematosus (SLE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids | Lupus Erythematosus, Systemic | Drug: Acthar Gel;Drug: Placebo Gel | Mallinckrodt | Not recruiting | 18 Years | N/A | All | 172 | Phase 4 | United States;Argentina;Chile;Mexico;Peru;Colombia | |
| 110 | JPRN-JapicCTI-183957 | 10/10/2016 | 16 July 2019 | A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE) | A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Intervention name : M2951 (Other Name: Evobrutinib) Dosage And administration of the intervention : M2951 low dose will be administered for 52 weeks. Intervention name : M2951 (Other Name: Evobrutinib) Dosage And administration of the intervention : M2951 mid dose will be administered for 52 weeks. Intervention name : M2951 (Other Name: Evobrutinib) Dosage And administration of the intervention : M2951 high dose will be administered for 52 weeks. Control intervention name : Placebo Dosage And administration of the control intervention : Placebo matched to M2951 will be administered for 52 weeks. | Merck Serono Co., Ltd. | Merck KGaA | Recruiting | 18 | 75 | BOTH | 451 | Phase 2 | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 111 | NCT02779153 | October 2016 | 30 September 2019 | Acthar SLE (Systemic Lupus Erythematosus) | Efficacy, Safety, and Steroid Sparing Effect of Acthar in Patients With Hematologic Manifestations of Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE);Repository Corticotropin Injection | Drug: Acthar low dose (40 U);Drug: Acthar high dose (80 U) | NYU Langone Health | Mallinckrodt | Not recruiting | 18 Years | N/A | All | 0 | Phase 4 | United States |
| 112 | NCT02842814 | October 2016 | 29 July 2019 | Prediction of Relapse Risk in Stable Systemic Lupus Erythematosus | Evaluation and Prediction of Relapse Risk After Glucocorticoid Withdrawal in Patients With Stable Systemic Lupus Erythematosus: An Open-labeled Multi-centric Randomized Controlled Study From China | Systemic Lupus Erythematosus | Other: Drug free;Drug: HCQ;Drug: GC+HCQ | Peking Union Medical College Hospital | Xiangya Hospital of Central South University;Shengjing Hospital;People's Hospital of Xinjiang Uygur Autonomous Region;Anhui Provincial Hospital | Recruiting | 18 Years | 60 Years | All | 350 | N/A | China |
| 113 | EUCTR2015-004457-40-DE | 19/09/2016 | 28 February 2019 | A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given. | A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS | SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 20.0 Level: LLT Classification code 10040967 Term: SLE System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Dapirolizumab pegol Current Sponsor code: DZP Other descriptive name: CDP7657 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solvent for solution for infusion Route of administration of the placebo: Intravenous use | UCB Biopharma SPRL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany | |||
| 114 | EUCTR2016-000625-39-HU | 18/08/2016 | 7 January 2019 | A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE | 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] | Product Name: Anifrolumab Product Code: MEDI-546 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Anifrolumab CAS Number: 1326232-46-5 Current Sponsor code: MEDI 546 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | AstraZeneca AB | Authorised | Female: yes Male: yes | 575 | Phase 3 | United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand | |||
| 115 | EUCTR2016-000488-17-AT | 08/08/2016 | 30 April 2019 | A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE) | A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) | Systematic 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: Body processes [G] - Immune system processes [G12] | Product Name: ILT-101 Product Code: ILT-101 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Aldesleukin CAS Number: 110942-02-4 Other descriptive name: INTERLEUKIN-2 Concentration unit: million IU million international units Concentration type: equal Concentration number: 1.2- Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of the placebo: Subcutaneous use | ILTOO PHARMA | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Portugal;France;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 116 | EUCTR2015-003341-25-DE | 29/07/2016 | 28 February 2019 | A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic Lupus Erythematosus MedDRA version: 19.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: IPP-201101 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: IPP-201101 Current Sponsor code: IPP-201101 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Subcutaneous use | ImmuPharma SA | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Hungary;Germany;United Kingdom | |||
| 117 | NCT03155477 | June 10, 2016 | 16 December 2017 | Effect Of Curcuma Xanthorrhiza and Vitamin D3 Supplementation in SLE Patients With Hypovitamin D | Effect Of Curcuma Xanthorrhiza Supplementation In Systemic Lupus Erythematosus Patients (SLE) With Hypovitamin D Which Were Given Vitamin D3 Towards Disease Activity (SLEDAI), Interleukin-6 (IL-6) And Tumor Growth Factor-ß1 (TGF-ß1) Serum | SLE | Dietary Supplement: Cholecalciferol and C. Xanthorrhiza;Dietary Supplement: Cholecalciferol and placebo | Saiful Anwar Hospital | Not recruiting | 18 Years | 45 Years | Female | 39 | N/A | ||
| 118 | NCT02804763 | June 2, 2016 | 22 July 2019 | A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus | A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Drug: Placebo;Drug: Dapirolizumab pegol (DZP) | UCB Biopharma S.P.R.L. | Not recruiting | 18 Years | N/A | All | 182 | Phase 2 | United States;Bulgaria;Chile;Colombia;Germany;Hungary;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Ukraine | |
| 119 | NCT02514967 | June 2016 | 16 December 2017 | CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis | Systemic Lupus Erythematosus | Drug: Blisibimod;Drug: Placebo | Anthera Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 3 | Phase 3 | Georgia | |
| 120 | NCT02741960 | May 24, 2016 | 30 September 2019 | The Effect of Metformin on Reducing Lupus Flares | A Multicenter, Randomised, Double-blind Placebo Controlled Trial on the Efficacy and Safety of add-on Metformin to Conventional Immunosuppressants in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: metformin;Drug: placebo | RenJi Hospital | Not recruiting | 18 Years | 70 Years | All | 180 | Phase 4 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 121 | NCT02932137 | May 5, 2016 | 11 June 2018 | Anti-infection of Low-does IL-2 in SLE | Potential Effect of Anti-infection by Low-dose IL-2 in Treatment of SLE | Systemic Lupus Erythematosus | Drug: Interleukin-2 | Peking University People's Hospital | Not recruiting | 18 Years | 60 Years | All | 30 | N/A | China | |
| 122 | EUCTR2015-003341-25-HU | 02/05/2016 | 18 June 2018 | A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus. | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE. | Systemic Lupus Erythematosus MedDRA version: 18.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: IPP-201101 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: IPP-201101 Current Sponsor code: IPP-201101 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Subcutaneous use | ImmuPharma SA | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Hungary;Germany | |||
| 123 | NCT02331810 | April 2016 | 13 June 2016 | Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients | A Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus Patient | Systemic Lupus Erythematosus | Drug: SAR113244;Drug: placebo | Sanofi | Not recruiting | 18 Years | 75 Years | Both | 0 | Phase 1 | ||
| 124 | NCT02618967 | March 28, 2016 | 17 September 2018 | Single Ascending Dose Study of AMG 570 in Healthy Subjects | A Randomized, Double Blind Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of AMG 570 in Healthy Subjects | Systemic Lupus Erythematosus | Biological: AMG 570;Biological: AMG 570 Matching Placebo | Amgen | Not recruiting | 18 Years | 65 Years | All | 56 | Phase 1 | United States | |
| 125 | NCT02708095 | March 24, 2016 | 3 December 2018 | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE) | A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 314 | Phase 2 | United States;Argentina;Austria;France;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Romania;Spain;Taiwan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 126 | JPRN-JapicCTI-163359 | 01/3/2016 | 2 April 2019 | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHH | A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHH | Systemic Lupus Erythematosus (SLE) | Intervention name : Baricitinib INN of the intervention : Baricitinib Dosage And administration of the intervention : Baricitinib given orally once a day for 24 weeks Control intervention name : Placebo Dosage And administration of the control intervention : Placebo given orally once a day for 24 weeks | Eli Lilly Japan K.K. | 18 | BOTH | Phase 2 | |||||
| 127 | NCT02711813 | March 2016 | 11 June 2018 | TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment | Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Concomitant Therapy | Lupus Erythematosus, Systemic | Drug: TAB08;Other: Placebo | Theramab LLC | Not recruiting | 18 Years | 60 Years | All | 60 | Phase 2 | Russian Federation | |
| 128 | NCT02725515 | February 16, 2016 | 26 August 2019 | A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus | A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity | Systemic Lupus Erythematosus | Biological: XmAb5871;Biological: Placebo to match XmAb5871 | Xencor, Inc. | PPD;ICON plc | Not recruiting | 18 Years | 65 Years | All | 105 | Phase 2 | United States |
| 129 | NCT02925351 | January 25, 2016 | 11 November 2019 | Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory Diseases | The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases | Autoimmune Disease;Crohn Disease;Inflammatory Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Takayasu Arteritis | Procedure: Computed Tomography;Radiation: Fluorine F 18 Clofarabine;Procedure: Positron Emission Tomography | Jonsson Comprehensive Cancer Center | National Cancer Institute (NCI) | Not recruiting | 18 Years | N/A | All | 8 | N/A | United States |
| 130 | NCT02483624 | January 2016 | 8 February 2016 | 3,3'-Diindolylmethane in Patients With Systemic Lupus Erythematosus | A Single-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of 3,3'-Diindolylmethane (BR-DIM) in Patients With Systemic Lupus Erythematosus (SLE) | SLE | Drug: BR-DIM;Drug: Placebo | North Shore Long Island Jewish Health System | Not recruiting | 18 Years | 50 Years | Female | 6 | Phase 1 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 131 | NCT02660944 | January 2016 | 26 August 2019 | A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: RSLV-132;Drug: Placebo | Resolve Therapeutics | Not recruiting | 18 Years | 70 Years | All | 64 | Phase 2 | United States | |
| 132 | NCT02677688 | January 2016 | 25 March 2019 | Autologous EBV-specific Cytotoxic T Cells for the Treatment of Systemic Lupus Erythematosus (SLE) | Restauration of EBV Control in SLE Phase 1-2 Trial Evaluating Adoptive Transfer of Autologous EBV- Specific Cytotoxic T Lymphocytes in SLE Treatment | Serologically Active Adult Systemic Lupus Erythematosus | Biological: Autologous EBV specific CTL infusion | Nantes University Hospital | Recruiting | 18 Years | N/A | All | 10 | Phase 1/Phase 2 | France | |
| 133 | ChiCTR-ONC-15007547 | 2015-12-05 | 18 April 2017 | Clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus: a multicenter prospective cohort study | Study of the clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus | systemic lupus erythematosus | The combination of Chinese and western group:Traditional Chinese medicine combined western medicine;Treating by Western Medicine group:Treating by Western medicine (sugar cortical hormone, hydroxychloroquine, and methotrexate, azathioprine, or cyclophosphamide); | Zhejiang Chinese Medical University | Recruiting | 18 | 60 | Both | The combination of Chinese and western group:264;Treating by Western Medicine group:264; | New Treatment Measure Clinical Study | China | |
| 134 | JPRN-UMIN000025328 | 2015/12/05 | 2 April 2019 | A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis | systemic lupus erythematosus | Tacrolimus Mycophenolate Mofetil | The University of Hong Kong | Recruiting | 18years-old | 75years-old | Male and Female | 200 | Not selected | Japan,Asia(except Japan) | ||
| 135 | NCT02074020 | December 2015 | 24 August 2015 | CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis | Systemic Lupus Erythematosus | Drug: Blisibimod;Drug: Placebo | Anthera Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 0 | Phase 3 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 136 | NCT02609789 | December 2015 | 25 March 2019 | A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus | A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Dose Study of JNJ-55920839 in Subjects With Mild to Moderate Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;Healthy | Drug: JNJ-55920839;Drug: Placebo | Janssen Research & Development, LLC | Not recruiting | 18 Years | 55 Years | All | 72 | Phase 1 | United States;Belgium;Moldova, Republic of;Poland;Romania;Spain;Taiwan | |
| 137 | NCT02885610 | December 2015 | 29 July 2019 | Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) | A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: RC18 80 mg plus standard therapy;Biological: RC18 160 mg plus standard therapy;Biological: RC18 240 mg plus standard therapy | RemeGen | Not recruiting | 18 Years | 65 Years | All | 249 | Phase 2 | China | |
| 138 | NCT02537028 | November 30, 2015 | 16 December 2017 | MSC2364447C Phase 1b in Systemic Lupus Erythematosus | A Phase Ib Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biological Effect of MSC2364447C in Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: MSC2364447C;Drug: Placebo | EMD Serono Research & Development Institute, Inc. | Merck KGaA | Not recruiting | 18 Years | 65 Years | All | 24 | Phase 1 | United States;Bulgaria |
| 139 | EUCTR2015-001341-86-DE | 19/11/2015 | 7 January 2019 | Phase IIb study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus | 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] | Product Name: IFN-Kinoid Product Code: IFN-K Pharmaceutical Form: Emulsion for injection INN or Proposed INN: Not yet assigned Current Sponsor code: IFN-K DS Other descriptive name: IFN-Kinoid Drug Substance Concentration unit: µg/ml microgram(s)/millilitre Concentration type: not less then Concentration number: 380- Pharmaceutical form of the placebo: Emulsion for injection Route of administration of the placebo: Intramuscular use | Neovacs S.A. | Authorised | Female: yes Male: yes | 178 | Phase 2 | United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany | |||
| 140 | NCT02477150 | November 2015 | 16 September 2019 | Safety and Immunogenicity of a Zoster Vaccine in SLE | Immunogenicity and Safety of a Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus: a Randomized Controlled Trial | Systemic Lupus Erythematosus | Biological: Zostavax;Biological: placebo | Tuen Mun Hospital | Not recruiting | 18 Years | N/A | All | 90 | Phase 4 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 141 | NCT02349061 | October 15, 2015 | 4 March 2019 | A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Ustekinumab IV;Drug: Placebo Infusion;Drug: Placebo SC;Drug: Ustekinumab SC;Other: Concomitant Medication | Janssen Research & Development, LLC | Not recruiting | 18 Years | 75 Years | All | 102 | Phase 2 | United States;Argentina;Australia;Germany;Hungary;Mexico;Poland;Spain;Taiwan;United Kingdom | |
| 142 | NCT02429934 | October 2015 | 29 April 2019 | Abatacept for SLE Arthritis (IM101-330) | Efficacy of Abatacept in Inflammatory Polyarthritis of Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus Arthritis | Drug: abatacept;Drug: Placebo | University of California, Los Angeles | Bristol-Myers Squibb | Recruiting | 18 Years | N/A | All | 64 | Phase 1/Phase 2 | United States |
| 143 | NCT02554019 | September 28, 2015 | 20 August 2018 | Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus | A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated Dose, Multicentre Phase IIa Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: BT063;Biological: Placebo | Biotest | Not recruiting | 18 Years | 75 Years | All | 36 | Phase 2 | Belarus;Georgia;Poland;Serbia | |
| 144 | EUCTR2014-005526-35-PL | 12/09/2015 | 30 April 2018 | Clinical study to evaluate the safety and tolerability of treatment with BT063 versus Placebo in Subjects with Systemic Lupus Erythematosus (BT063 in SLE) | A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated dose, Multicentre Phase IIa Proof-of-Concept Study with BT063 in Subjects with Systemic Lupus Erythematosus (BT063 in SLE) | Systemic Lupus Erythematosus MedDRA version: 19.1 Level: LLT Classification code 10042947 Term: Systemic lupus erythematosus synd System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BT063 Product Code: BT063 Pharmaceutical Form: Solution for infusion INN or Proposed INN: BT063 Current Sponsor code: BT063 Other descriptive name: BT063 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Biotest AG | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Serbia;Belarus;Poland;Georgia | |||
| 145 | JPRN-UMIN000020859 | 2015/09/01 | 2 April 2019 | Effects of Royal Jelly Supplementation on Regulatory T Cells and Lymphocytes Apoptosis in Children with Systemic Lupus Erythematosus | Systemic Lupus Erythematosus. | two-month Royal Jelly (2 gm) treatment | Faculty of medicine, University of Assiut, Assiut 71516, Egypt. | Not Recruiting | 8years-old | 17years-old | Male and Female | 30 | Not selected | Africa | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 146 | NCT02665364 | September 2015 | 6 May 2019 | Study of IFN-K in Systemic Lupus Erythematosus | A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: IFN-Kinoid;Other: Placebo;Other: ISA 51 | Neovacs | Not recruiting | 18 Years | 65 Years | All | 178 | Phase 2 | United States;Belgium;Chile;Colombia;Croatia;France;Georgia;Germany;Italy;Korea, Republic of;Mexico;Moldova, Republic of;Peru;Philippines;Poland;Russian Federation;Taiwan;Thailand | |
| 147 | NCT02535689 | August 28, 2015 | 20 August 2018 | Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus | Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus; a Phase Ib Clinical Trial and Associated Mechanistic Studies | Systemic Lupus Erythematosus | Drug: Tofacitinib;Drug: Placebo | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | 100 Years | All | 34 | Phase 1 | United States | |
| 148 | EUCTR2014-004632-19-LT | 20/08/2015 | 28 February 2019 | A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | 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] | Product Name: Anifrolumab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Anifrolumab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of | |||
| 149 | JPRN-JapicCTI-153077 | 01/8/2015 | 2 April 2019 | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of lulizumab pegol of Subjects with Active Systemic Lupus Erythematosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects with Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Intervention name : Lulizumab pegol Dosage And administration of the intervention : Four treatments of lulizumab pegol will be administered along with placebo treatment:12.5 mg weekly, 12.5 mg every other week (EOW), 5 mg EOW and 1.25mg EOW, on a background of limited standard of care medications. The dose levels may be modified based on the interim analysis results. Control intervention name : null | Bristol-Myers Squibb K.K. | 18 | 70 | BOTH | 350 | Phase 2 | |||
| 150 | EUCTR2014-004633-96-GB | 16/07/2015 | 28 February 2019 | A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus | 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] | Product Name: Anifrolumab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Anifrolumab CAS Number: 1326232-46-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use Product Name: Anifrolumab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Anifrolumab CAS Number: 1326232-46-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 151 | NCT02446899 | July 9, 2015 | 29 July 2019 | Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Biological: Anifrolumab;Drug: Placebo | AstraZeneca | PRA Health Sciences | Not recruiting | 18 Years | 70 Years | All | 373 | Phase 3 | United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Lithuania;Mexico;Russian Federation;South Africa;Spain;Czech Republic;Czechia;Singapore |
| 152 | NCT02437890 | July 2015 | 19 November 2018 | A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus | A Phase II Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Biological: ALX-0061;Biological: Placebo | Ablynx | Not recruiting | 18 Years | 64 Years | All | 312 | Phase 2 | United States;Argentina;Chile;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Peru;Philippines;Poland;Portugal;Russian Federation;Serbia;Spain;Taiwan;Ukraine;Czech Republic | |
| 153 | NCT02444728 | July 2015 | 16 December 2017 | Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLE | Cyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus Erythematosus | Thrombocytopenia | Drug: Hydroxychloroquine;Drug: Cyclophosphamide;Drug: Azathioprine;Drug: Methylprednisolone | Chinese SLE Treatment And Research Group | Peking Union Medical College Hospital | Recruiting | 18 Years | 70 Years | All | 220 | Phase 3 | China |
| 154 | NCT02477254 | July 2015 | 31 October 2016 | Long-term Immunogenicity of a HPV Vaccine in SLE | Long-term Immunogenicity of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With Systemic Lupus Erythematosus: a Case-control Study | Systemic Lupus Erythematosus | Biological: Vaccination | Tuen Mun Hospital | Not recruiting | 18 Years | 35 Years | Female | 84 | N/A | China | |
| 155 | NCT02533570 | July 2015 | 16 December 2017 | Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus | A Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Brentuximab vedotin;Drug: Placebo | Seattle Genetics, Inc. | Not recruiting | 18 Years | N/A | All | 20 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 156 | EUCTR2014-002984-14-BG | 05/06/2015 | 8 May 2017 | International clinical trial to evaluate the biological activity and safety of ACT-334441 in lupus | A multicenter, randomized, double-blind, placebo-controlled, dose-response study to investigate the biological activity, safety, tolerability, and pharmacokinetics of ACT-334441 in subjects with systemic lupus erythematosus. - | Systemic lupus erythematosus ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: ACT-334441 Pharmaceutical Form: Capsule, hard Other descriptive name: ACT-334441 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5,1,2,-4 Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | ACTELION Pharmaceuticals Ltd | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | Belarus;United States;Ukraine;Russian Federation;Georgia;Bulgaria | |||
| 157 | NCT02472795 | June 1, 2015 | 16 July 2018 | Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus | A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Placebo;Drug: ACT-334441 | Idorsia Pharmaceuticals Ltd. | Not recruiting | 18 Years | 65 Years | All | 64 | Phase 2 | United States;Belarus;Bulgaria;Georgia;Russian Federation;Ukraine | |
| 158 | NCT02465580 | June 2015 | 29 June 2015 | A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus | A Phase II Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: hrIL-2 active;Drug: hrIL-2 placebo | Peking University People's Hospital | Monash University;Beijing SL Pharmaceutical Company Ltd | Recruiting | 18 Years | 65 Years | Both | 60 | Phase 2 | China |
| 159 | EUCTR2014-005418-45-SE | 04/05/2015 | 22 May 2017 | Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) | Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE | Rheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Plaquenil Pharmaceutical Form: Film-coated tablet INN or Proposed INN: HYDROXYCHLOROQUINE CAS Number: 118-42-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- | Christine Bengtsson | Solveig Wållberg-Jonsson | Not Recruiting | Female: yes Male: yes | Phase 2 | Sweden | |||
| 160 | NCT01773616 | April 2015 | 12 February 2018 | Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus Nephritis | Phase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus Nephritis | Systemic Lupus Erythematosus, Lupus Nephritis | Drug: Oral prednisolone;Drug: Rituximab;Drug: Mycophenolate mofetil;Drug: Methyl prednisolone | Imperial College London | Karolinska Institutet;Ohio State University;Dutch Working Party on Systemic Lupus Erythematosus;EULAR Lupus Nephritis Trial Network Study Group | Not recruiting | 12 Years | 75 Years | All | 24 | Phase 3 | United Kingdom |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 161 | NCT02548936 | April 2015 | 21 September 2015 | Efficacy and Safety of Simvastatin-ezetimibe Combination Therapy Among Patients With SLE | Efficacy and Safety of Simvastatin-ezetimibe Combination Therapy in Reduction of Progression of Atherosclerosis Among Patients With Systemic Lupus Erythematosus: A Randomized Single-Blind Trial | Atherosclerosis | Drug: Ezetimibe+Simvastatin Drug Combination | Peking Union Medical College Hospital | Recruiting | 18 Years | 65 Years | Both | 30 | Phase 0 | China | |
| 162 | NCT02504645 | March 2015 | 23 April 2019 | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: IPP-201101;Drug: Placebo;Other: Standard of Care | ImmuPharma | Not recruiting | 18 Years | 70 Years | All | 202 | Phase 3 | United States;Czechia;France;Germany;Hungary;Mauritius;Poland;Puerto Rico;Czech Republic;Italy | |
| 163 | NCT02307643 | February 2015 | 16 December 2017 | Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients | An Exploratory Study of MT-1303 in Subjects With Systemic Lupus Erythematosus (a Multicenter, Open-label Study) | Systemic Lupus Erythematosus | Drug: MT-1303 Low dose;Drug: MT-1303 High dose | Mitsubishi Tanabe Pharma Corporation | Not recruiting | 20 Years | 64 Years | All | 17 | Phase 1 | Japan | |
| 164 | NCT01845740 | January 2015 | 12 October 2015 | Phase Ib Study of SC Milatuzumab in SLE | A Phase Ib Study of Milatuzumab Administered Subcutaneously in Patients With Active Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus, Cutaneous;Lupus Erythematosus, Discoid;Lupus Erythematosus, Systemic;Lupus Vasculitis, Central Nervous System;Lupus Nephritis | Drug: milatuzumab;Drug: Placebo | Immunomedics, Inc. | Department of Defense | Recruiting | 18 Years | N/A | Both | 30 | Phase 1/Phase 2 | United States |
| 165 | JPRN-jRCTs071180052 | 26/12/2014 | 10 September 2019 | Control of steroid-associated osteonecrosis of the femoral head in SLE patients | Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus - None | systemic lupus erythematosus;D008180 | Objectives take three below candidate drugs for the prevention for at least 3 months after the initial corticosteroid treatment. 1. Clopidogrel Bisulfate (Plavix) Taking a dose of 300mg once daily on the first day, and a dose of 75mg once daily on subsequent days. 2. Pitavastatin Calcium (LIVALO) Taking a dose of 2mg once daily. 3. Tocopherol Acetate (Juvela) Taking a dose of 100mg three times daily (total of 300mg daily). | Yasuharu Nakashima | Recruiting | 20 years-old | Not applicable | Both | 150 | Phase 2 | none | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 166 | NCT02265744 | November 13, 2014 | 22 October 2019 | Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus | Lupus | Drug: BMS-931699;Drug: Placebo matching BMS-931699 | Bristol-Myers Squibb | Not recruiting | 18 Years | 70 Years | All | 730 | Phase 2 | Chile;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Lebanon;Mexico;Netherlands;Peru;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Argentina;Brazil;Canada;United States;Qatar | |
| 167 | NCT02306629 | November 2014 | 25 May 2015 | Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood | An Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese Subjects | Systemic Lupus Erythematosus | Biological: Epratuzumab sc;Biological: Epratuzumab iv | UCB Biopharma S.P.R.L. | Pharmaceutical Research Associates;Richmond Pharmacology Limited;ACM Global Europe;Eurofins Pharma Bioanalysis;The Doctors Laboratory | Not recruiting | 18 Years | 50 Years | Both | 42 | Phase 1 | United Kingdom |
| 168 | NCT02321709 | November 2014 | 9 May 2016 | Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients | A Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus Patients | Systemic Lupus Erythematosus | Drug: SAR113244;Drug: placebo | Sanofi | Not recruiting | 18 Years | 75 Years | Both | 21 | Phase 1 | Germany | |
| 169 | NCT02080195 | October 2014 | 16 December 2017 | Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE) | A Phase I/II Study of Nonmyeloablative Conditioning and Transplantation of Human Leukocyte Antigen (HLA)-Matched, Partially HLA-mismatched, HLA-haploidentical or Matched Unrelated Bone Marrow for Patients With Refractory SLE | Lupus Erythematosus;Graft-versus-host Disease | Drug: Cyclophosphamide;Drug: Sodium-2-mercapto ethane sulphonate;Drug: Fludarabine monophosphate;Drug: Tacrolimus;Drug: Mofetil;Drug: Rabbit antithymocyte globulin | Sidney Kimmel Comprehensive Cancer Center | Not recruiting | 18 Years | 75 Years | All | 1 | Phase 1/Phase 2 | United States | |
| 170 | NCT02102594 | October 2014 | 10 December 2018 | Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB) | Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB) | Myasthenia Gravis;Systemic Lupus Erythematosus;Rheumatoid Arthritis | Drug: Bortezomib | Charite University, Berlin, Germany | Prof. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology);NeuroCure Clinical Research Center, Charite, Berlin | Recruiting | 18 Years | 75 Years | All | 18 | Phase 2 | Germany |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 171 | NCT02270970 | October 2014 | 16 December 2017 | Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding Polypharmacy | Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding Polypharmacy | Systemic Lupus Erythematosus | Biological: belimumab | Oklahoma Medical Research Foundation | GlaxoSmithKline | Recruiting | 16 Years | 70 Years | All | 20 | Phase 4 | United States |
| 172 | NCT02281513 | October 2014 | 27 May 2019 | Activity and Nutrition Trial in Lupus to Energize and Renew | Activity and Nutrition Trial in Lupus to Energize and Renew | Systemic Lupus Erythematosus;Physical Activity;Sleep | Other: Smartphone Application;Other: Fitbit Activity Monitor;Other: Coaching Sessions | Northwestern University | Not recruiting | 18 Years | N/A | All | 12 | N/A | United States | |
| 173 | NCT02185040 | September 16, 2014 | 2 September 2019 | A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus. | A Pilot, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study To Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Pharmacogenetics of CC-220 In Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: CC-220;Drug: Placebo | Celgene | Not recruiting | 18 Years | N/A | All | 42 | Phase 2 | United States | |
| 174 | NCT02066311 | September 2014 | 20 August 2018 | Nelfinavir in Systemic Lupus Erythematosus | Nelfinavir in Systemic Lupus Erythematosus: A Pilot Phase IIa Clinical Trial | Systemic Lupus Erythematosus | Drug: Nelfinavir | Northwell Health | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | 65 Years | All | 15 | Phase 2 | United States |
| 175 | JPRN-UMIN000008230 | 2014/08/01 | 2 April 2019 | Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus | Systemic lupus erythematosus | Objectives take three below candidate drugs for the prevention for at least 3 months after the initial corticosteroid treatment. 1. Clopidgrel Bisulfate (Plavix) Taking a dose of 300mg once daily on the first day, and a dose of 75mg once daily on subsequent days. 2. Pitavastatin Calcium (LIVALO) Taking a dose of 2mg once daily. 3. Tocopherol Acetate (Juvela) Taking a dose of 100mg three times daily (total of 300mg daily). | Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University | Recruiting | 20years-old | Not applicable | Male and Female | 150 | Phase 2 | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 176 | NCT02070978 | July 29, 2014 | 1 April 2019 | Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II) | A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed Protocol EMR-700461-023 (ADDRESS II) | Lupus Erythematosus, Systemic | Drug: Atacicept 75 mg;Drug: Atacicept 150 mg | EMD Serono | Not recruiting | 18 Years | N/A | All | 253 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom | |
| 177 | EUCTR2013-005362-19-DE | 17/07/2014 | 17 July 2017 | Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB) | Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB) - TAVAB | Myasthenia Gravis Systemic Lupus Erythematosus Rheumatoid Arthritis ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Velcade® Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: BORTEZOMIB CAS Number: 179324-69-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3,5- | Charité - Universitätsmedizin Berlin | Authorised | Female: yes Male: yes | Phase 2 | Germany | ||||
| 178 | NCT02194400 | July 2014 | 21 December 2015 | Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus | A Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: RSLV-132 | Resolve Therapeutics | Not recruiting | 18 Years | 70 Years | Both | 32 | Phase 1 | United States | |
| 179 | NCT02124798 | May 20, 2014 | 11 June 2018 | A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an Autoinjector | An Open-Label Single-Arm Study to Evaluate the Reliability of an Autoinjector That Administers Belimumab Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Device: Belimumab autoinjector | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 95 | Phase 2 | United States | |
| 180 | NCT02119156 | May 13, 2014 | 21 January 2019 | Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients | An Open-label, Non-randomized, 52-Week Study to Evaluate Treatment Holidays and Rebound Phenomenon After Treatment With Belimumab 10 mg/kg in Systemic Lupus Erythematosus Subjects | Systemic Lupus Erythematosus | Drug: Belimumab | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 80 | Phase 3 | Korea, Republic of;China;Japan;United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 181 | EUCTR2014-000488-42-NL | 12/05/2014 | 30 April 2019 | Synergetic B-cell immunomodulation in SLE | The SYNBioSe Study A proof-of-concept study involving synergetic B-cell imunnomodulation in patients with refractory systemic lupus erythematosus - SynBiose | Systemic lupus erythematosus MedDRA version: 17.0 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: rituximab Product Name: Rituximab Pharmaceutical Form: Infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Current Sponsor code: Teng-001 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2000- Trade Name: Benlysta Product Name: Belimumab Pharmaceutical Form: Infusion INN or Proposed INN: BELIMUMAB CAS Number: 356547-88-1 Current Sponsor code: Teng-001 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 10- | Leiden University Medical Center | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | Netherlands | |||
| 182 | NCT01956188 | May 2014 | 16 December 2017 | Omega 3 in LES and APS | Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome | Systemic Lupus Erythematosus;Primary Antiphospholipid Syndrome | Dietary Supplement: EPA and DHA supplementation;Dietary Supplement: Placebo | University of Sao Paulo | Not recruiting | 20 Years | 45 Years | Female | 22 | N/A | Brazil | |
| 183 | NCT02106897 | April 30, 2014 | 16 December 2017 | Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 in Healthy Volunteers and Participants With Systemic Lupus Erythematosus | A Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus;Healthy Volunteers | Drug: BIIB059;Drug: Placebo | Biogen | Not recruiting | 18 Years | N/A | All | 109 | Phase 1 | United States | |
| 184 | JPRN-UMIN000012478 | 2014/04/01 | 16 July 2019 | Open label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosus | Open label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosus - Hydroxychloroquine for systemic lupus erythematosus | systemic lupus erythematosus cutaneous lupus erythematosus | Treatment with Hydroxychloroquine | Department of Internal Medicine, Teikyo University School of Medicine | Recruiting | Not applicable | Not applicable | Male and Female | 10 | Not selected | Japan | |
| 185 | JPRN-UMIN000013508 | 2014/03/28 | 2 April 2019 | A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus:cross over additional trial | Systemic lupus erythmatosus | saline bortezomib(1.3mg/m2) 2times/week total 8times. | Tohoku university hospital | Not Recruiting | 20years-old | 65years-old | Male and Female | 14 | Phase 2 | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 186 | NCT01988506 | January 6, 2014 | 27 August 2018 | Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases | Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach | Rheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic Sclerosis | Drug: Interleukin 2 | Assistance Publique - Hôpitaux de Paris | Iltoo Pharma | Recruiting | 18 Years | N/A | All | 132 | Phase 2 | France |
| 187 | EUCTR2013-001599-40-DE | 03/01/2014 | 10 July 2015 | Evaluation of the therapeutic potential of a low-dose therapy with the interleukin-2 analogue Aldesleukin (Proleukin®) in the treatment of systemic lupus erythematosus. | Evaluation of the safety, tolerability, efficacy and immunological responses of the interleukin-2 analogue Aldesleukin (Proleukin®) in the treatment of systemic lupus erythematosus as prototypic autoimmune disease (PRO-IMMUN). A COMBINED PHASE I/IIA, PROSPECTIVE, OPEN-LABEL AND UNCONTROLLED SINGLE-CENTER STUDY TO ANALYSE SAFETY, TOLERABILITY, EFFICACY AND IMMUNOLOGICAL RESPONSES OF LOW-DOSE SUBCUTANEOUS INTERLEUKIN-2 (ALDESLEUKIN, PROLEUKIN®) IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS AND INCREASED DISEASE ACTIVITY REFRACTORY TO STANDARD THERAPIES. - PRO-IMMUN | Patients with systemic lupus erythematosus (SLE) and increased disease activity refractory to standard therapies. MedDRA version: 18.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0 Level: PT Classification code 10067657 Term: Systemic lupus erythematosus disease activity index increased System Organ Class: 10022891 - Investigations ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Proleukin Product Name: Proleukin Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: Aldesleukin CAS Number: 110942-02-4 Other descriptive name: ALDESLEUKIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.3- | Charité - Universitätsmedizin Berlin | Not Recruiting | Female: yes Male: yes | Phase 1/2A | Germany | ||||
| 188 | NCT02041091 | January 2014 | 18 January 2016 | A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus | Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Tabalumab Auto-Injector;Drug: Tabalumab Prefilled Syringe | Eli Lilly and Company | Not recruiting | 18 Years | N/A | Both | 226 | Phase 3 | United States;Korea, Republic of;Puerto Rico;Mexico | |
| 189 | NCT02270957 | January 2014 | 16 December 2017 | Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches | Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches (The ABC Study) | Systemic Lupus Erythematosus | Biological: Abatacept;Other: Placebo | Oklahoma Medical Research Foundation | Bristol-Myers Squibb | Recruiting | 18 Years | 70 Years | All | 60 | Phase 2 | United States |
| 190 | NCT02558517 | January 2014 | 22 August 2016 | 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 | Recruiting | 18 Years | 75 Years | Both | 136 | Phase 3 | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 191 | NCT01972568 | December 2013 | 16 December 2017 | Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus | A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus, Systemic | Drug: Atacicept 75 milligram (mg);Drug: Atacicept 150 mg;Drug: Placebo | EMD Serono | Not recruiting | 18 Years | N/A | All | 306 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Japan;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom;Czech Republic;Ukraine | |
| 192 | NCT01946880 | November 20, 2013 | 26 August 2019 | 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 | Not recruiting | 18 Years | 70 Years | All | 102 | Phase 2 | United States |
| 193 | JPRN-UMIN000012227 | 2013/11/06 | 2 April 2019 | A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus | Systemic lupus erythmatosus | bortezomib(1.3mg/m2) 2times/week total 8times. saline | Tohoku university hospital | Not Recruiting | 20years-old | 65years-old | Male and Female | 14 | Phase 2 | Japan | ||
| 194 | NCT01894360 | October 14, 2013 | 16 December 2017 | A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy Subjects | A Randomized, Parallel-Group, Open-Label Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Administered Subcutaneously to Healthy Subjects by Prefilled Syringe or Autoinjector | Systemic Lupus Erythematosus | Drug: Belimumab 200 mg/mL | GlaxoSmithKline | Not recruiting | 18 Years | 55 Years | All | 81 | Phase 1 | United States | |
| 195 | NCT01953835 | October 4, 2013 | 16 December 2017 | A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184 | A Two-part Healthy Volunteer Study to Investigate Both the Interaction of GSK2586184 With Rosuvastatin and Simvastatin and to Compare the Pharmacokinetics of Two Different Formulations of GSK2586184 | Systemic Lupus Erythematosus | Drug: GSK2586184 standard formulation;Drug: Simvastatin;Drug: Rosuvastatin;Drug: GSK2586184 new formulation | GlaxoSmithKline | Not recruiting | 18 Years | 65 Years | All | 37 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 196 | NCT02084238 | August 2013 | 19 October 2017 | Low-dose IL-2( Interleukin-2) Treatment in SLE | Safety and Efficiency Study of Low-dose IL-2 Treatment in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Interleukin-2 | Peking University People's Hospital | Monash University | Not recruiting | 18 Years | 65 Years | All | 40 | N/A | China |
| 197 | NCT01709474 | June 2013 | 19 October 2017 | Vitamin D3 Treatment in Pediatric Systemic Lupus Erythematosus | Vitamin D3 Effects on Immune Function in Pediatric Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Vitamin D3 6000 IU;Drug: Vitamin D3 400 IU | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Not recruiting | 5 Years | 20 Years | All | 7 | Phase 2 | United States |
| 198 | NCT01753193 | March 28, 2013 | 27 August 2018 | An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults | A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Biological: MEDI-546 | MedImmune LLC | Not recruiting | 18 Years | 68 Years | All | 218 | Phase 2 | United States;Brazil;Bulgaria;Colombia;Czechia;Hungary;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Czech Republic | |
| 199 | NCT01777256 | March 1, 2013 | 16 December 2017 | An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 | An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 in Patients With Mild to Moderate Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: GSK2586184 50 mg;Drug: GSK2586184 100 mg;Drug: GSK2586184 200 mg;Drug: GSK2586184 400 mg;Drug: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | 75 Years | All | 51 | Phase 2 | Argentina;Chile;Czechia;Estonia;France;Germany;Greece;Hong Kong;Hungary;Korea, Republic of;Peru;Poland;Romania;South Africa;Spain;Sweden;Brazil;Czech Republic | |
| 200 | NCT01729455 | February 21, 2013 | 11 November 2019 | Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus Registry | A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without BENLYSTA™ (Belimumab) | Systemic Lupus Erythematosus | Biological: BENLYSTA;Other: SLE treatment | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Recruiting | 18 Years | N/A | All | 3000 | Phase 2 | United States;Argentina;Austria;Belgium;Canada;France;Germany;Israel;Italy;Portugal;Slovakia;Spain;Sweden |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 201 | EUCTR2012-001645-41-DE | 19/02/2013 | 1 December 2014 | A study to assess the efficacy and safety of GSK2586184 in SLE | An adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus. | Systemic Lupus Erythematosus MedDRA version: 16.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] | Product Name: GSK2586184 Product Code: GSK2586184 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: GSK2586184 CAS Number: 1206163-45-2 Current Sponsor code: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: GSK2586184 Product Code: GSK2586184 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: GSK2586184 CAS Number: 1206163-45-2 Current Sponsor code: GSK2586184 Other descriptive name: N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | GlaxoSmithKline Research and Development Limited | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | India;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Germany;Sweden;Korea, Republic of;Thailand;Russian Federation;Chile;Estonia;Hong Kong;Greece;Spain | |||
| 202 | NCT01632241 | February 19, 2013 | 26 August 2019 | Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) | A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Drug: Standard therapy | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 503 | Phase 4 | United States;Brazil;Colombia;France;South Africa;United Kingdom |
| 203 | NCT01395745 | February 2013 | 16 December 2017 | CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: blisibimod;Drug: Placebo | Anthera Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 442 | Phase 3 | Belarus;Brazil;Colombia;Georgia;Guatemala;Hong Kong;India;Korea, Republic of;Malaysia;Mexico;Philippines;Russian Federation;Singapore;Sri Lanka;Taiwan;Thailand | |
| 204 | NCT01781611 | February 2013 | 16 December 2017 | Dipyridamole Assessment for Flare Reduction in Systemic Lupus Erythematosus (SLE) | Dipyridamole Assessment for Flare Reduction in SLE | Systemic Lupus Erythematosus | Drug: extended release dipyridamole 200mg/aspirin 25mg;Drug: 81mg aspirin | Oklahoma Medical Research Foundation | Recruiting | 18 Years | 70 Years | All | 50 | N/A | United States | |
| 205 | EUCTR2011-005667-25-HU | 22/01/2013 | 27 October 2014 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 17.1 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: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: BELIMUMAB CAS Number: 356547-88-1 Other descriptive name: Benlysta Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Powder for concentrate for solution for infusion Route of administration of the placebo: Intravenous use | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | Authorised | Female: yes Male: yes | 5000 | Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 206 | EUCTR2011-005667-25-EE | 08/01/2013 | 28 February 2019 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | 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: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: BELIMUMAB CAS Number: 356547-88-1 Other descriptive name: Benlysta Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Powder for concentrate for solution for infusion Route of administration of the placebo: Intravenous use | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | Authorised | Female: yes Male: yes | 4000 | Phase 4 | Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | |||
| 207 | NCT01741012 | January 2013 | 29 June 2015 | Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients | Phase I, Safety and Immunogenicity of Gardasil® in Systemic Lupus Erythematosus. | Systemic Lupus Erythematosus | Drug: Gardasil | Wayne State University | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | 50 Years | Female | 40 | Phase 1 | United States |
| 208 | NCT01764594 | January 2013 | 3 August 2015 | Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus | A Multicenter, Investigator- and Subject-Blind, Randomized, Placebo-Controlled, Parallel-Group, Repeat-Dose Study to Evaluate the Effect of CDP7657 in Subjects With Active Systemic Lupus Erythematosus | Immune System Diseases;Autoimmune Diseases;Lupus Erythematosus, Systemic;Skin and Connective Tissue Diseases;Connective Tissue Disease | Biological: CDP7657;Other: Placebo | UCB Pharma | Biogen | Not recruiting | 18 Years | 75 Years | Both | 24 | Phase 1 | Belgium;Bulgaria;Germany;Poland;Romania;Russian Federation;Spain |
| 209 | NCT01753401 | December 2012 | 5 December 2016 | Acthar for the Treatment of Systemic Lupus Erythematosus in Patients With a History of Persistently Active Disease | A Two-part Study Exploring the Efficacy, Safety, and Pharmacodynamics of Acthar in Systemic Lupus Erythematosus Patients With a History of Persistently Active Disease | Systemic Lupus Erythematosus (SLE) | Drug: Acthar;Drug: Placebo for Acthar | Mallinckrodt | Not recruiting | 18 Years | N/A | Both | 36 | Phase 4 | United States | |
| 210 | NCT01705977 | November 27, 2012 | 15 July 2019 | Belimumab Assessment of Safety in SLE | A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Systemic Lupus Erythematosus | Biological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Other: Standard therapy | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 4019 | Phase 4 | United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Estonia;Hong Kong;Hungary;Indonesia;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Taiwan;Thailand;Ukraine;Czech Republic;Norway |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 211 | NCT01686555 | November 2012 | 16 December 2017 | A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE) | Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus | Drug: ABT-199;Other: Placebo | AbbVie (prior sponsor, Abbott) | Not recruiting | 18 Years | 65 Years | Female | 97 | Phase 1 | United States;Germany;Mexico;Puerto Rico | |
| 212 | EUCTR2012-002345-38-GB | 30/10/2012 | 30 April 2019 | Comparison of rivaroxaban (Xarelto®; Bayer HealthCare), fixed-dose oral anticoagulant (blood thinner), versus warfarin in patients with antiphospholipid syndrome (called APS), with or without 'lupus' (systemic lupus erythematosus) | A prospective randomised controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE. - Rivaroxaban in Antiphospholipid Syndrome (RAPS) | Patients with antiphospholipid syndrome (APS), with or without systemic lupus erythematosus (SLE). MedDRA version: 14.1 Level: PT Classification code 10002817 Term: Antiphospholipid syndrome System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Xarelto Product Name: Rivaroxaban Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Rivaroxaban CAS Number: 366789-02-8 Other descriptive name: Trade name Xarelto Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15-20 Trade Name: The generic name is warfarin and many producers will be involved Product Name: Warfarin Pharmaceutical Form: Tablet INN or Proposed INN: Warfarin CAS Number: 81-81-2 Concentration unit: Other | University College London | Not Recruiting | Female: yes Male: yes | 156 | Phase 2 | United Kingdom | |||
| 213 | NCT01687192 | October 2012 | 10 August 2015 | Multicenter Trial Evaluating the Immunogenicity of HPV Vaccination in Girls on Immunosuppressive Therapy. | Multicenter Clinical Trial Evaluating the Immunological Response of Vaccination Against Infection by Human Papillomavirus (HPV) 6, 11, 16, 18 in Girls Receiving Immunosuppressive Therapy. | Transplantation;Systemic Lupus Erythematosus;Systemic Immune Disease | Biological: HPV prophylactic vaccine Gardasil | University Hospital, Bordeaux | Not recruiting | 9 Years | 18 Years | Female | 37 | Phase 2 | France | |
| 214 | NCT01769937 | October 2012 | 19 February 2015 | Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus | A Single-site, Investigator Initiated Open-Label Trial of H.P. Acthar Gel (Repository Corticotropin Injection)an Adrenocorticotropic Hormone (ACTH) Analogue in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus Systemic Exacerbation | Drug: H.P. Acthar Gel | Fiechtner, Justus J., M.D., P.C. | Not recruiting | 18 Years | 75 Years | Both | 10 | Phase 4 | United States | |
| 215 | NCT01649765 | September 7, 2012 | 10 September 2018 | Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy | A Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: belimumab 10mg/kg;Other: placebo | GlaxoSmithKline | Human Genome Sciences Inc., a GSK Company | Not recruiting | 5 Years | 17 Years | All | 93 | Phase 2 | United States;Argentina;Canada;Italy;Japan;Mexico;Netherlands;Peru;Poland;Russian Federation;Spain;United Kingdom;Brazil |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 216 | ChiCTR-TRC-12002419 | 2012-09-01 | 18 April 2017 | The clinical research of metformin in achievienging the reduction in Flare of Mild/Moderate Active Lupus Patients | The clinical research of metformin in achievienging the reduction in Flare of Mild/Moderate Active Lupus Patients | systemic lupus erythematosus | 1:Background treatment( - hydroxychloroquine );2:Background treatment( + hydroxychloroquine );3:Background treatment + hydroxychloroquine + Metformin; | Renji Hospital, Shanghai JiaoTong University School of Medicine | Not Recruiting | 18 | 70 | Both | 1:60;2:60;3:60; | Other | China | |
| 217 | NCT01689025 | September 2012 | 19 February 2015 | An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE) | A Randomised, Placebo-controlled, Double-blind, Multiple-dose, Dose-escalation Trial Investigating the Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus | Inflammation;Systemic Lupus Erythematosus | Drug: NNC0114-0006;Drug: placebo | Novo Nordisk A/S | Not recruiting | 18 Years | 64 Years | Both | 10 | Phase 1 | United States;Hungary;Poland;Serbia | |
| 218 | NCT01597050 | August 2012 | 19 October 2017 | Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of R333 6% Ointment Administered Topically to Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Patients With Active Cutaneous Discoid Lesions | Lupus Erythematosus, Discoid;Lupus Erythematosus, Systemic | Drug: R932333;Drug: Placebo | Rigel Pharmaceuticals | Not recruiting | 18 Years | 75 Years | All | 54 | Phase 2 | United States;Canada | |
| 219 | NCT01532310 | July 16, 2012 | 15 July 2019 | Belimumab (BENLYSTA®) Pregnancy Registry | WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol | Systemic Lupus Erythematosus | Drug: belimumab | GlaxoSmithKline | PPD | Recruiting | N/A | N/A | Female | 500 | Phase 2 | United States |
| 220 | NCT01892748 | July 2012 | 23 May 2016 | Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus. | Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus. | Systemic Lupus Erythematosus | Drug: Cholecalciferol;Drug: Placebo | ROSA MARIA RODRIGUES PEREIRA | Not recruiting | 10 Years | 25 Years | Female | 60 | N/A | Brazil | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 221 | EUCTR2011-000368-88-GB | 13/06/2012 | 5 August 2014 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 17.0 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: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: belimumab CAS Number: 356547-88-1 Current Sponsor code: GSK1550188 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 80- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | GlaxoSmithKline Research & Development Ltd | Authorised | Female: yes Male: yes | 100 | United States;Mexico;Canada;Argentina;Poland;Brazil;Spain;Peru;Russian Federation;Netherlands;Italy;United Kingdom | ||||
| 222 | NCT01597622 | June 11, 2012 | 22 October 2018 | BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115 | BEL114333, a Multicenter, Continuation Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase III Study BEL113750 in Northeast Asia or Completed the Open-label Extension of HGS1006-C1115 in Japan | Systemic Lupus Erythematosus | Drug: Belimumab | GlaxoSmithKline | Human Genome Sciences Inc. | Not recruiting | 18 Years | N/A | All | 143 | Phase 3 | Japan;Korea, Republic of |
| 223 | JPRN-JapicCTI-121864 | 01/6/2012 | 2 April 2019 | A Phase I study of rontalizumab | A Phase I study of rontalizumab | Systemic lupus erythematosus (SLE) | Intervention name : Rontalizumab Dosage And administration of the intervention : Single and multiple subcutaneous administration of 3 different doses of rontalizumab Control intervention name : null | Chugai Pharmaceutical Co., Ltd. | 20 | 64 | BOTH | 21 | Phase 1 | |||
| 224 | NCT01683695 | June 2012 | 16 December 2017 | Safety Study of AMG 557 in Subjects With Lupus Arthritis | A Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus Arthritis | Lupus Arthritis, Systemic Lupus Erythematosus | Drug: AMG 557;Drug: Matching Placebo | Amgen | Not recruiting | 18 Years | 65 Years | All | 20 | Phase 1 | United States;Australia;Denmark;France;Germany;Malaysia;Taiwan;United Kingdom;Singapore | |
| 225 | NCT01597492 | May 31, 2012 | 20 August 2018 | A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 4, Multi-Center, Randomized, Open-Label Study to Evaluate the Effect of BENLYSTA™ (Belimumab; HGS1006) on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Biological: Belimumab plus Early Vaccination;Biological: Belimumab plus Late Vaccination | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 79 | Phase 4 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 226 | EUCTR2011-005392-16-ES | 23/05/2012 | 26 June 2012 | Stydy to evaluate the efficacy and security of anakinra for the treatment of unresponsiveness arthritis to conventional treatment in systemic lupus erythematosus | Study to evaluate the efficacy and safety of Anakinra in the treatment of articular manifestations refractory to conventional therapy in Systemic Lupus Erythematosus patients - ANAKINRA AND LUPUS ARTHRITIS | Systemic lupus erythematosus MedDRA version: 14.1 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: KINERET Product Name: KINERET Product Code: KINERET Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ANAKINRA CAS Number: 143090-92-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Dr Josep Ordi Ros | Authorised | Female: yes Male: yes | Spain | |||||
| 227 | NCT01687309 | April 30, 2012 | 11 June 2018 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK2586184 and the Effect of Food and Gender | A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586184 Following a Single Doseof 800mg and Repeat Oral Tablet Doses of 800mg b.d and the Effect of Food and Gender on the Pharmacokinetics of oralGSK2586184 in Healthy Subjects | Systemic Lupus Erythematosus | Drug: GSK2586184 800mg single and repeat dose;Drug: Placebo-to-match GSK2586184;Other: GSK2586184 single dose taken with food;Other: GSK2586184 single dose taken without food | GlaxoSmithKline | Not recruiting | 18 Years | 65 Years | All | 19 | Phase 1 | Belgium | |
| 228 | NCT01559090 | April 20, 2012 | 25 March 2019 | Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus. | A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Intravenous Dose of MEDI-546, a Human Monoclonal Antibody Directed Against Type I Interferon Receptor (IFNAR), in Japanese Subjects With Active Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus | Drug: MEDI-546 | AstraZeneca | MedImmune LLC | Not recruiting | 18 Years | 65 Years | All | 17 | Phase 2 | Japan |
| 229 | NCT01616472 | April 2012 | 2 May 2016 | WEUKBRE5716: Steroid-related Damage in Systemic Lupus Erythematosus (Hopkins) | WEUKBRE5716: Quantifying the Burden of Steroid-related Damage in Systemic Lupus Erythematosus in the Hopkins Lupus Cohort | Systemic Lupus Erythematosus | Drug: Cumulative corticosteroid exposure | GlaxoSmithKline | Not recruiting | N/A | N/A | Both | 1 | N/A | ||
| 230 | NCT01551069 | March 2012 | 19 February 2015 | Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion | A Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin Lesion | Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus | Drug: hydroxychloroquine (Z0188);Drug: Placebo | Sanofi | Not recruiting | 18 Years | N/A | Both | 103 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 231 | NCT01440231 | February 2012 | 19 February 2015 | Atacicept Demonstrating Dose RESponSe | A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Dose-Response Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: Atacicept | EMD Serono | Not recruiting | 18 Years | N/A | Both | 0 | Phase 2 | United States | |
| 232 | NCT01438489 | January 2012 | 19 October 2017 | A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus | A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Anifrolumab 300 mg;Biological: Anifrolumab 1000 mg;Other: Placebo | MedImmune LLC | Not recruiting | 18 Years | 65 Years | All | 626 | Phase 2 | United States;Brazil;Bulgaria;Colombia;Czech Republic;Hungary;India;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Hong Kong | |
| 233 | NCT01488708 | January 2012 | 11 June 2018 | On Open-Label Study in Participants With Systemic Lupus Erythematosus | A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) (Illuminate-X) | Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune Disease | Drug: LY2127399;Drug: Placebo | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 1518 | Phase 3 | United States | |
| 234 | NCT01534403 | January 2012 | 16 March 2015 | Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects | A Phase 2, Multicenter, Open-label, Long-term, Extension Study to Assess the Safety of Epratuzumab Treatment in Japanese Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Epratuzumab | UCB Pharma | Not recruiting | 18 Years | 65 Years | Both | 17 | Phase 2 | Japan | |
| 235 | NCT01741857 | January 2012 | 19 February 2015 | Umbilical Cord Derived Mesenchymal Stem Cells Transplantation for Active and Refractory Systemic Lupus Erythematosus | Phase I/II: Umbilical Cord Derived Mesenchymal Stem Cells Transplantation For Active And Refractory Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: human umbilical cord derived MSC transplantation for SLE | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | 15 Years | 60 Years | Both | 40 | Phase 1/Phase 2 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 236 | NCT02021513 | January 2012 | 19 February 2015 | Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus | Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Dietary Supplement: Fish Oil;Dietary Supplement: Olive Oil | University of Texas Southwestern Medical Center | Not recruiting | 18 Years | 64 Years | Both | 50 | Phase 2 | United States | |
| 237 | NCT01516450 | December 26, 2011 | 16 December 2017 | Japanese phase1 Study of Belimumab (IV vs SC) | An Open Label, Randomized, Parallel, Single Dose Study to Investigate Safety and Pharmacokinetics Following Intravenous Administration and Subcutaneous Administration of GSK1550188 in Healthy Japanese Males | Systemic Lupus Erythematosus | Drug: GSK1550188 IV;Drug: GSK1550188 SC | GlaxoSmithKline | Not recruiting | 20 Years | 55 Years | Male | 16 | Phase 1 | Japan | |
| 238 | NCT01405196 | December 2011 | 8 January 2018 | Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus | A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle) | Lupus Erythematosus, Systemic | Biological: PF-04236921 | Pfizer | Not recruiting | 18 Years | 75 Years | All | 183 | Phase 2 | United States;Argentina;Chile;Colombia;Germany;Hungary;Korea, Republic of;Moldova, Republic of;Peru;Poland;Puerto Rico;Romania;Taiwan;Mexico | |
| 239 | NCT01484496 | November 16, 2011 | 11 June 2018 | A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Biological: Placebo;Biological: Belimumab 200 mg SC;Drug: Standard therapy | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 839 | Phase 3 | United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Croatia;Czechia;Denmark;France;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic |
| 240 | NCT01474720 | November 2011 | 19 February 2015 | Zostavax in Systemic Lupus Erythematosus | Immunologic Response to Varicella Zoster Vaccination With Zostavax in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Zostavax vaccine | Oklahoma Medical Research Foundation | Not recruiting | 50 Years | 75 Years | Both | 20 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 241 | NCT01541670 | November 2011 | 16 December 2017 | Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis | A Study to Assess the Safety and Tolerability of Anti-MIF Antibody in Subjects With Lupus Nephritis | Systemic Lupus Erythematosus | Drug: Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody | Baxalta now part of Shire | Not recruiting | 18 Years | N/A | All | 4 | Phase 1 | United States;Australia;Canada;Mexico;New Zealand | |
| 242 | NCT01359826 | October 2011 | 28 September 2015 | The Effect of Milnacipran on Fatigue and Quality of Life in Lupus Patients | The Effect of Milnacipran on Fatigue and Quality of Life in a Lupus Cohort | Systemic Lupus Erythematosus;Widespread Pain;Fibromyalgia | Drug: Milnacipran | Loma Linda University | Forest Laboratories | Not recruiting | 18 Years | N/A | Both | 0 | Phase 4 | United States |
| 243 | NCT01449071 | October 2011 | 19 February 2015 | Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) | A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe Disease | Systemic Lupus Erythematosus | Biological: Placebo;Biological: Epratuzumab 400 mg;Biological: Epratuzumab 1200 mg;Biological: Epratuzumab 100 mg;Biological: Epratuzumab 600 mg | UCB Pharma | Not recruiting | 18 Years | 64 Years | Both | 20 | Phase 1/Phase 2 | Japan | |
| 244 | EUCTR2010-023396-25-GB | 22/09/2011 | 25 February 2013 | A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE) | Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis - SMILE | Systemic lupus erythematosus (SLE) MedDRA version: 14.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: . CAS Number: . Current Sponsor code: SM101 Other descriptive name: soluble Fc receptor Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | SuppreMol GmbH | Authorised | Female: yes Male: yes | 50 | Phase 2a | France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom | |||
| 245 | NCT01911169 | June 2011 | 16 December 2017 | Vitamin D to Improve Endothelial Function in SLE | Vitamin D Repletion to Improve Endothelial Function in Lupus Patients | Atherosclerosis;Systemic Lupus Erythematosus | Drug: Cholecalciferol | Medical University of South Carolina | Not recruiting | 18 Years | 80 Years | All | 9 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 246 | EUCTR2010-018563-41-BE | 25/05/2011 | 17 August 2015 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1 | Systemic Lupus Erythmatosus MedDRA version: 17.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Epratuzumab CAS Number: 205923-57-5 Current Sponsor code: CDP3194 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | UCB Inc. | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Australia;Bulgaria;Germany;Korea, Republic of;Brazil;Belgium;Mexico;Czech Republic;India;United Kingdom;Italy;Russian Federation;Israel;Lithuania;Spain;Taiwan;Estonia | |||
| 247 | EUCTR2010-020859-30-BE | 25/05/2011 | 8 August 2016 | Open-label study of long-term Epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE) | A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4) - EMBODY 4 | Systemic Lupus Erythematosus MedDRA version: 18.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Epratuzumab CAS Number: 205923-57-5 Current Sponsor code: CDP3194 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | UCB Inc. | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | United States;Estonia;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany | |||
| 248 | NCT01345253 | May 23, 2011 | 7 October 2019 | GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia | GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia | Systemic Lupus Erythematosus | Drug: Belimumab;Drug: Placebo | GlaxoSmithKline | Human Genome Sciences Inc. | Not recruiting | 18 Years | N/A | All | 709 | Phase 3 | China;Japan;Korea, Republic of |
| 249 | EUCTR2010-024131-16-DE | 06/05/2011 | 2 June 2014 | Efficacy and Safety of oral Alitretinoin (Toctino®) in the Treatment of Patients with Cutaneous Lupus Erythematosus: A Multicentre, Open-Label, Prospective Pilot Study | Efficacy and Safety of oral Alitretinoin (Toctino®) in the Treatment of Patients with Cutaneous Lupus Erythematosus: A Multicentre, Open-Label, Prospective Pilot Study - AliCLE | ?dult subjects of any ethnicity and either gender with Subacute Cutaneous Lupus Erythematosus (SCLE), Discoid Lupus Erythematosus (DLE), Lupus erythematosus tumidus (LET) or Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions and without major organ involvement to investigate the efficacy of alitretinoin (30 mg per day) in the treatment of Cutaneous Lupus Erythematosus lesions. MedDRA version: 16.0 Level: PT Classification code 10056509 Term: Cutaneous lupus erythematosus System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Toctino® Pharmaceutical Form: Capsule, soft INN or Proposed INN: ALITRETINOIN CAS Number: 5300-03-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- | Universitätsklinikum Münster | Not Recruiting | Female: yes Male: yes | 33 | Germany | ||||
| 250 | NCT01858792 | May 2011 | 19 February 2015 | A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies | Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients With Higher Disease Activity (Anti-dsDNA Positive and Low Complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies | Lupus Erythematosus, Discoid | Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Other: Placebo | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Not recruiting | 18 Years | N/A | Both | 1 | N/A | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 251 | NCT02799173 | April 15, 2011 | 20 August 2018 | Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification | Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification | Osteoporosis;Lupus Erythematosus, Systemic | Biological: RANKL/OPG ratio;Device: bone densitometry;Device: fan beam CT scan;Device: Doppler ultrasound | Centre Hospitalier Universitaire, Amiens | Not recruiting | 18 Years | 99 Years | Female | 74 | N/A | France | |
| 252 | NCT01305746 | April 2011 | 19 February 2015 | A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 | An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC) | Systemic Lupus Erythematosus | Drug: A-623 | Anthera Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 382 | Phase 2 | United States;Argentina;Brazil;Chile;Colombia;Hong Kong;India;Mexico;Peru;Philippines;Taiwan | |
| 253 | NCT01283139 | March 31, 2011 | 11 June 2018 | A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus | A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Sifalimumab 200 mg;Biological: Sifalimumab 600 mg;Biological: Sifalimumab 1,200 mg;Other: Placebo | MedImmune LLC | Not recruiting | 18 Years | 75 Years | All | 834 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Canada;Chile;France;Germany;Hungary;India;Italy;Jamaica;Mexico;Netherlands;Peru;Philippines;Poland;Romania;South Africa;Spain;Thailand;United Kingdom | |
| 254 | EUCTR2010-023645-29-DE | 15/03/2011 | 28 August 2014 | Efficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLE | Efficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLE | Adult subjects of any ethnicity and either gender with Cutaneous Lupus Erythematosus lesions of Subacute Cutaneous Lupus Erythematosus (SCLE), Discoid Lupus Erythematosus (DLE), Lupus erythematosus tumidus (LET) or Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions and without major organ involvement to investigate the efficacy of fumaric acid esters in the treatment of Cutaneous Lupus Erythematosus lesions. MedDRA version: 12.1 Level: LLT Classification code 10056509 Term: Cutaneous lupus erythematosus MedDRA version: 12.1 Level: PT Classification code 10056509 Term: Cutaneous lupus erythematosus | Trade Name: Fumaderm® initial Product Name: - Product Code: - Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: Dimethylfumarat Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 67- INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Trade Name: Fumaderm® Product Name: - Product Code: - Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: Dimethylfumarat Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 120- INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 87- INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- | Universitätsklinikum Münster | Not Recruiting | Female: yes Male: yes | 11 | Germany | ||||
| 255 | NCT03979976 | March 2011 | 24 June 2019 | Ramipril, Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus | Ramipril Improves Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus: a Randomized and Controlled Study. | Systemic Lupus Erythematosus | Drug: Ramipril | Federal University of São Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo | Not recruiting | 18 Years | N/A | Female | 37 | Phase 2/Phase 3 | Brazil |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 256 | EUCTR2010-019293-32-DE | 10/02/2011 | 10 June 2013 | A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus) | An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.1 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] | Product Name: Lupuzor Product Code: CEP-33457 Pharmaceutical Form: Powder for injection INN or Proposed INN: Forigerimod CAS Number: 1160237-55-7 Current Sponsor code: CEP-33457 Other descriptive name: IPP-201101, P140 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- | Cephalon, Inc. | Not Recruiting | Female: yes Male: yes | 130 | Germany;Ukraine;Belgium;Poland;Spain;Czech Republic;Hungary;Portugal;United States | ||||
| 257 | EUCTR2010-018565-26-HU | 16/01/2011 | 4 August 2015 | Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE) | A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2 | Systemic Lupus Erythmatosus MedDRA version: 17.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Epratuzumab Product Code: CDP3194 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Epratuzumab CAS Number: 205923-57-5 Current Sponsor code: CDP3194 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | UCB Inc. | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | Hungary;Mexico;Canada;Spain;Brazil;Ukraine;Russian Federation;South Africa;Germany;Italy;United Kingdom;India | |||
| 258 | NCT01205438 | January 2011 | 25 June 2018 | A Study of LY2127399 in Participants With Systemic Lupus Erythematosus | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune Disease | Drug: LY2127399;Drug: Placebo every 2 weeks;Drug: Placebo every 4 weeks | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 1124 | Phase 3 | Ecuador;France;Hungary;India;Israel;Latvia;Malaysia;Mexico;New Zealand;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Tunisia;United Kingdom;United States;Canada;Brazil;Australia | |
| 259 | NCT01217320 | January 2011 | 19 February 2015 | Creatine Supplementation in Pediatric Rheumatology | Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis | Juvenile Systemic Lupus Erythematosus;Juvenile Dermatomyositis | Dietary Supplement: creatine;Dietary Supplement: placebo (dextrose) | University of Sao Paulo | Recruiting | 6 Years | 18 Years | Both | 40 | N/A | Brazil | |
| 260 | NCT01276782 | January 2011 | 21 September 2015 | Levothyroxine in Pregnant SLE Patients | Pilot Double-Blind Placebo Controlled Trial of Levothyroxine in Pregnant Systemic Lupus Erythematosus (SLE) Patients With Autoimmune Thyroid Disease | Systemic Lupus Erythematosus | Drug: Levothyroxine | Johns Hopkins University | New York University School of Medicine;Duke University;University of Chicago;Stanford University | Not recruiting | 18 Years | 45 Years | Female | 0 | Phase 4 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 261 | NCT01196091 | December 2010 | 25 June 2018 | A Study of LY2127399 in Participants With Systemic Lupus Erythematosus | A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune Disease | Drug: Standard of Care;Drug: Placebo every 4 weeks;Drug: Placebo every 2 weeks;Drug: LY2127399 | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 1164 | Phase 3 | United States;Argentina;Austria;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Egypt;Germany;Guatemala;Italy;Japan;Korea, Republic of;Macedonia, The Former Yugoslav Republic of;Peru;Philippines;Poland;Puerto Rico;Singapore;Thailand;Ukraine;Turkey | |
| 262 | NCT01240694 | December 2010 | 17 September 2018 | A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus Erythematosus | An Open-Label Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Lupuzor | Cephalon | Not recruiting | 18 Years | 70 Years | All | 136 | Phase 3 | United States;Belgium;Czechia;France;Germany;Hungary;Poland;Portugal;Spain;Ukraine;United Kingdom;Czech Republic | |
| 263 | NCT01269866 | December 2010 | 19 February 2015 | Study of Duloxetine in the Reduction of Pain in Patient With Systemic Lupus Erythematosus | Duloxetine (Cymbalta) in the Reduction of Pain Severity in Patient With Systemic Lupus Erythematosus: A Pilot Study | Systemic Lupus Erythematosus | Drug: Cymbalta | Dr. Jesus Gutierrez Stone | Not recruiting | 18 Years | 65 Years | Both | 26 | N/A | United States | |
| 264 | EUCTR2009-017273-38-ES | 26/10/2010 | 14 August 2012 | 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 Pharmaceutical Form: Capsule, soft INN or Proposed INN: CICLOSPORINA CAS Number: 59865-13-3 Other descriptive name: CICLOSPORIN Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 500- Pharmaceutical Form: INN or Proposed INN: PREDNISONA CAS Number: 53-03-2 Other descriptive name: PREDNISONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Product Name: Acido Micofenolico Product Code: ACM Pharmaceutical Form: Tablet INN or Proposed INN: MICOFENOLICO ACIDO Other descriptive name: MYCOPHENOLIC ACID | Manuel Praga Terente | Not Recruiting | Female: yes Male: yes | 38 | Spain | ||||
| 265 | JPRN-UMIN000004182 | 2010/10/01 | 2 April 2019 | efficacy and safety of tacrolimus for mild/modelate flare in patients with systemic lupus erythematosus | systemic lupus erythematosus | Administration of Tacrolimus | Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences | Recruiting | 20years-old | 80years-old | Male and Female | 30 | Not applicable | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 266 | EUCTR2010-018383-16-DE | 17/09/2010 | 11 February 2013 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0 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] | Product Name: Lupuzor Product Code: CEP-33457 Pharmaceutical Form: Powder for injection INN or Proposed INN: Forigerimod CAS Number: 1160237-55-7 Current Sponsor code: CEP-33457 Other descriptive name: IPP-201101, P140 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Powder for injection Route of administration of the placebo: Subcutaneous use | Cephalon, Inc. | Not Recruiting | Female: yes Male: yes | 220 | Germany;Ukraine;Belgium;Poland;Spain;Czech Republic;Hungary;France;Portugal;United States | ||||
| 267 | NCT00979654 | August 2010 | 19 October 2017 | A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis | A Phase 2 Open-label Study to Evaluate the Long-term Safety of Sifalimumab in Adult Subjects With Systemic Lupus Erythematosus or Myositis | Systemic Lupus Erythematosus | Drug: Sifalimumab | MedImmune LLC | PPD | Not recruiting | 18 Years | 99 Years | All | 118 | Phase 2 | United States;Brazil;Canada;Chile |
| 268 | NCT01164917 | August 2010 | 19 February 2015 | Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus | A Randomized, Double-blind, Placebo-controlled, Single Dose, Two-period, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of AMG 811 in Subjects With Discoid Lupus Erythematosus | Cutaneous Lupus;Discoid Lupus;Lupus;Systemic Lupus Erythematosus | Drug: AMG811;Drug: AMG811 Placebo | Amgen | Not recruiting | 18 Years | 70 Years | Both | 16 | Phase 1 | United States | |
| 269 | NCT01381536 | July 20, 2010 | 16 December 2017 | Phase I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE) | GSK1550188, A Randomised, Single-blind, Placebo Controlled, Dose Ascending, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: GSK1550188 1mg/kg or 10mg/kg | GlaxoSmithKline | Not recruiting | 20 Years | N/A | All | 12 | Phase 1 | Japan | |
| 270 | NCT01085084 | July 2010 | 8 August 2016 | Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus Arthritis | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients With Active Lupus Arthritis | Lupus Arthritis | Drug: Laquinimod;Other: Placebo | Teva Pharmaceutical Industries | Not recruiting | 18 Years | 75 Years | Both | 82 | Phase 2 | United States;Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 271 | NCT01162681 | July 2010 | 19 February 2015 | PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus | A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: A-623;Other: Placebo Comparator | Anthera Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 547 | Phase 2 | United States;Argentina;Brazil;Chile;Colombia;Hong Kong;India;Mexico;Peru;Philippines;Taiwan | |
| 272 | NCT01135459 | June 2010 | 8 August 2016 | A Study to Evaluate the Efficacy and Safety of CEP-33457 in Patients With Systemic Lupus Erythematosus | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Lupuzor;Drug: Placebo | Cephalon | Not recruiting | 18 Years | 70 Years | Both | 183 | Phase 2 | Poland;Portugal;Spain;Ukraine;United Kingdom;Belgium;Czech Republic;France;Germany;Hungary;United States | |
| 273 | NCT01060410 | May 2010 | 19 February 2015 | Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus Treatment | Exploration of Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus Treatment | Lupus Erythematosus, Systemic;Adverse Effects | Genetic: Polymorphism Analysis;Drug: Cyclophosphamide;Other: Pharmacokinetic analysis | Sun Yat-sen University | First Affiliated Hospital, Sun Yat-Sen University | Not recruiting | 12 Years | 80 Years | Both | 222 | N/A | China |
| 274 | NCT01127321 | May 2010 | 19 October 2017 | A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus | A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE | Lupus Erythematosus, Systemic | Other: Placebo;Biological: MEDI-570 0.03 MG;Biological: MEDI-570 0.1 MG;Biological: MEDI-570 0.3 MG;Biological: MEDI-570 1 MG | MedImmune LLC | AstraZeneca | Not recruiting | 18 Years | N/A | All | 44 | Phase 1 | United States;Canada;Mexico;Peru;South Africa |
| 275 | NCT01151644 | April 2010 | 19 February 2015 | Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases | Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases | Rheumatoid Arthritis;Spondyloarthritis;Systemic Lupus Erythematosus (SLE);Dermatomyositis (DM);DMixed Connective Tissue Disease;Systemic Vasculitis;Systemic Sclerosis (SSc);Sjögren's Syndrome;Antiphospholipid Syndrome;Juvenile Idiopathic Arthritis;Juvenile SLE;Juvenile DM | Biological: Anti-pandemic H1N1 influenza vaccine | University of Sao Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo | Not recruiting | N/A | N/A | Both | 5000 | Phase 4 | Brazil |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 276 | NCT01425775 | April 2010 | 19 February 2015 | The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: vitamin D 25(OH)D;Other: Placebo | Faculty of Medicine, University of Alexandria | Not recruiting | 18 Years | 60 Years | Both | 248 | N/A | Egypt | ||
| 277 | NCT01058343 | March 2010 | 1 April 2019 | Safety of IFNa Kinoid in Systemic Lupus Erythematosus | A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNa-Kinoid in Adult Subjects With Systemic Lupus Erythematosus. | Systemic Lupus Erythematosus | Biological: IFN-K | Neovacs | Not recruiting | 18 Years | 50 Years | All | 28 | Phase 1/Phase 2 | Belgium;Bulgaria;Croatia;France;Germany;Switzerland;Romania;Spain | |
| 278 | NCT01093911 | March 2010 | 19 February 2015 | Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE) | A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients. | Immune System Diseases;Autoimmune Diseases;Lupus Erythematosus, Systemic;Skin and Connective Tissue Diseases;Connective Tissue Disease | Biological: CDP7657;Other: Placebo | UCB Pharma | Not recruiting | 18 Years | 60 Years | Both | 44 | Phase 1 | Belgium;Bulgaria;Germany | |
| 279 | EUCTR2006-006214-16-GB | 23/02/2010 | 19 March 2012 | A randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLE | A randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLE | Systemic lupus erythematosus. MedDRA version: 13.1 Level: LLT Classification code 10042944 Term: Systemic lupus erythematosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Crestor Product Name: Crestor Pharmaceutical Form: Tablet INN or Proposed INN: ROSUVASTATIN CALCIUM CAS Number: 147098-20-2 Other descriptive name: rosuvastatin Concentration unit: g gram(s) Concentration type: equal Concentration number: 0.07-0.14 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Crestor Product Name: Crestor Pharmaceutical Form: Tablet INN or Proposed INN: ROSUVASTATIN CALCIUM CAS Number: 147098-20-2 Other descriptive name: rosuvastatin Concentration unit: g gram(s) Concentration type: equal Concentration number: 13.8- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Imperial College | Authorised | Female: yes Male: yes | United Kingdom | |||||
| 280 | EUCTR2009-012059-47-BE | 28/01/2010 | 23 January 2017 | A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 14.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: IFN-a2b Kinoid Product Code: IFN-K Pharmaceutical Form: Emulsion for injection INN or Proposed INN: Not assigned yet Current Sponsor code: IFN-K DS Other descriptive name: IFN-a 2b Kinoid Drug Substance Concentration unit: µg/ml microgram(s)/millilitre Concentration type: range Concentration number: 350-450 Pharmaceutical form of the placebo: Emulsion for injection Route of administration of the placebo: Intramuscular use | Neovacs SA | Not Recruiting | Female: yes Male: yes | 28 | Phase 1;Phase 2 | France;Belgium;Bulgaria;Germany | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 281 | NCT01413230 | January 2010 | 19 February 2015 | Vitamin D Supplementation in Systemic Lupus Erythematosus | Evaluation of Immunologic Response After Vitamin D Supplementation in Patients With Systemic Lupus Erythematosus | Vitamin D Deficiency | Drug: cholecalciferol | Assistance Publique - Hôpitaux de Paris | Not recruiting | 18 Years | N/A | Both | 20 | N/A | France | |
| 282 | NCT01006681 | November 2009 | 19 February 2015 | Vaccination Against Influenza H1N1 in Rheumatic Diseases | Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Immunomodulatory Drugs | Influenza;Rheumatic Diseases | Biological: Focetria (Monovalent MF59-Adjuvanted vaccine) | Tel-Aviv Sourasky Medical Center | Not recruiting | 18 Years | 65 Years | Both | 400 | Phase 2 | ||
| 283 | NCT01018238 | November 2009 | 19 February 2015 | An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE) | A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Multiple Site Study of Anti-C5a Receptor Antibody (NNC 0151-0000-0000) in Subjects With Systemic Lupus Erythematosus (SLE) | Inflammation;Systemic Lupus Erythematosus | Drug: NNC 0151-0000-0000;Drug: placebo | Novo Nordisk A/S | Not recruiting | 18 Years | 65 Years | Both | 0 | Phase 1 | United States | |
| 284 | NCT01031836 | November 2009 | 8 August 2016 | A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus. | A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: MEDI-545;Drug: MEDI-545 600 | AstraZeneca | MedImmune LLC | Not recruiting | 20 Years | 130 Years | Both | 42 | Phase 2 | Japan |
| 285 | NCT00911521 | October 2009 | 19 February 2015 | Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With SLE: a Controlled Study | Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With Systemic Lupus Erythematosus (SLE): a Controlled Study | Systemic Lupus Erythematosus | Drug: human papillomavirus vaccination (Gardasil) | Tuen Mun Hospital | Not recruiting | N/A | 35 Years | Female | 100 | Phase 4 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 286 | NCT00962832 | September 2009 | 22 August 2016 | A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus | A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rontalizumab (rhuMAb IFNalpha) in Patients With Moderately to Severely Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Placebo;Drug: Rontalizumab | Genentech, Inc. | Not recruiting | 18 Years | 65 Years | Both | 238 | Phase 2 | United States;Argentina;Colombia;Mexico;Poland;Russian Federation;United Kingdom | |
| 287 | NCT01072734 | September 2009 | 19 February 2015 | Auto-immunity in Lupus Patients After Influenza Vaccine | Role of CXCR4/CXCL12 Axis on the Control of Humoral Immunity and Auto-immunity in Lupus Patients After Influenza Vaccine Challenge | Systemic Lupus Erythematosus (SLE) | Drug: Vaccine | Assistance Publique - Hôpitaux de Paris | Institut National de la Santé Et de la Recherche Médicale, France | Not recruiting | 18 Years | N/A | Both | 28 | Phase 2 | France |
| 288 | NCT00960362 | July 2009 | 19 February 2015 | An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE) | A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus Erythematosus | Inflammation;Systemic Lupus Erythematosus (SLE) | Drug: AGS-009;Drug: placebo | Argos Therapeutics | Not recruiting | 18 Years | 65 Years | Both | 13 | Phase 1 | United States;Sweden | |
| 289 | NCT01914770 | July 2009 | 19 February 2015 | Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76 | Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76 | Systemic Lupus Erythematosus | Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Drug: Placebo | GlaxoSmithKline | Human Genome Sciences Inc. | Not recruiting | 18 Years | N/A | Both | 1016 | N/A | |
| 290 | EUCTR2009-011245-55-SE | 06/05/2009 | 9 September 2013 | An Exploratory Study to Evaluate Changes in Disease Activity and Biomarkers During Treatment With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE). Final Protocol dated 2009-03-16, Protocol Amendment 1 dated 2009-10-13, Protocol Amendment 2 dated 2009-12-02 | An Exploratory Study to Evaluate Changes in Disease Activity and Biomarkers During Treatment With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE). Final Protocol dated 2009-03-16, Protocol Amendment 1 dated 2009-10-13, Protocol Amendment 2 dated 2009-12-02 | Systemic Lupus Erythematosus (SLE) | Product Name: ABR-215757 Product Code: ABR-215757 Pharmaceutical Form: Capsule, hard INN or Proposed INN: paquinimod CAS Number: 248282-01-1 Current Sponsor code: ABR-215757 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5-mg milligram(s) | Active Biotech Research AB | Not Recruiting | Female: yes Male: yes | 20 | Denmark;Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 291 | NCT00976729 | May 2009 | 19 February 2015 | NOX-E36 First-in-Human (FIH) Study | NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects | Chronic Inflammatory Diseases;Type 2 Diabetes Mellitus;Systemic Lupus Erythematosus | Drug: NOX-E36;Drug: Placebo | NOXXON Pharma AG | Not recruiting | 18 Years | 60 Years | Both | 72 | Phase 1 | United Kingdom | |
| 292 | NCT00987831 | May 2009 | 19 October 2017 | Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE) | Biomarkers of Lupus Disease: Study of Biomarker Changes Before and After Treatment With Depomedrol and Background Medication Withdrawal in Patients With Mild to Moderate SLE Disease Activity | Systemic Lupus Erythematosus | Other: Group B SLE one blood donation;Other: Blood drawing only Group C;Drug: Group A SLE prospective study | Oklahoma Medical Research Foundation | Pfizer | Not recruiting | 14 Years | 70 Years | All | 158 | Phase 1/Phase 2 | United States |
| 293 | NCT00714116 | March 2009 | 18 December 2018 | Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus | An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Sbi-087 Administered To Subjects With Systemic Lupus Erythematosus. | Lupus Erythematosus, Systemic | Drug: SBI-087 | Pfizer | Emergent Product Development Seattle LLC | Not recruiting | 18 Years | 70 Years | All | 30 | Phase 1 | United States;Canada |
| 294 | NCT00775476 | March 2009 | 30 September 2019 | Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine | Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine | Systemic Lupus Erythematosus | Drug: N-acetylcysteine;Drug: Placebo | State University of New York - Upstate Medical University | Not recruiting | 18 Years | N/A | All | 478 | Phase 1/Phase 2 | United States | |
| 295 | NCT00818948 | March 2009 | 19 February 2015 | Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis | Nephritis;Systemic Lupus Erythematosus | Drug: AMG 811 | Amgen | Not recruiting | 18 Years | 70 Years | Both | 56 | Phase 1 | United States;France;Hong Kong;Malaysia;Mexico;Singapore | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 296 | NCT02524795 | March 2009 | 24 August 2015 | Omega 3 Fatty Acids and Systemic Lupus Erythematosus | Omega 3 Fatty Acids, Inflammatory Status and Biochemical Markers of Patients With Systemic Lupus Erythematosus: a Pilot Study | Systemic Lupus Erythematosus | Dietary Supplement: Hiomega-3 supplement of Naturalis® company - | Federal University of Minas Gerais | Not recruiting | 18 Years | 60 Years | Female | 49 | N/A | ||
| 297 | EUCTR2008-004852-62-IT | 09/02/2009 | 19 March 2012 | Safety and clinical efficacy of abetimus sodium (LJP-394) in prevention of renal flares in patients with systemic lupus erythematosus and a history of renal disease. - ABETIMUS FOR LUPUS NEPHRITIS | Safety and clinical efficacy of abetimus sodium (LJP-394) in prevention of renal flares in patients with systemic lupus erythematosus and a history of renal disease. - ABETIMUS FOR LUPUS NEPHRITIS | MedDRA version: 9.1 Level: SOC Classification code 10028395 MedDRA version: 9.1 Level: LLT Classification code 10040970 | Product Name: ABETIMUS SODIUM Product Code: LJP394 Pharmaceutical Form: Solution for injection INN or Proposed INN: RIQUENT Concentration unit: mg/l milligram(s)/litre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use | AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLI | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 298 | EUCTR2008-003833-25-DE | 05/02/2009 | 19 March 2012 | Efficacy ans safety of subcutaneous Efalizumab in the treatment of patients with cutaneous lupus erythematosus: A mono-centre, open-label, prospective pilot study - EFALUPUS | Efficacy ans safety of subcutaneous Efalizumab in the treatment of patients with cutaneous lupus erythematosus: A mono-centre, open-label, prospective pilot study - EFALUPUS | Cutaneous lupus erythematosus (discoid LE or subacute cutaneous LE) or systemic lupus erythematosus with cutaneous DLE or SCLE lesions without major organ involvment. MedDRA version: 9.1 Level: LLT Classification code 10013071 Term: Discoid lupus erythematosis MedDRA version: 9.1 Level: LLT Classification code 10057903 Term: Subacute cutaneous lupus erythematosus MedDRA version: 9.1 Level: LLT Classification code 10056509 Term: Cutaneous lupus erythematosus | Trade Name: Raptiva Pharmaceutical Form: Powder and solvent for solution for injection | Universitätskrankenhaus Schleswig-Holstein | Not Recruiting | Female: yes Male: yes | 17 | Germany | ||||
| 299 | NCT00828178 | February 2009 | 19 October 2017 | Efficacy of Fish Oil in Lupus Patients | A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE. | Systemic Lupus Erythematosus | Drug: Omega-3;Device: flow-mediated dilation of the brachial artery;Other: corn starch | Michelle Petri M.D.,MPH | Not recruiting | 18 Years | N/A | All | 106 | Phase 4 | United States | |
| 300 | NCT00774943 | December 2008 | 19 February 2015 | A Study of AMG 557 in Adults With Systemic Lupus Erythematosus | A Randomized, Double-blind, Placebo-controlled, Ascending, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: AMG 557 | Amgen | Not recruiting | 18 Years | 70 Years | Both | 58 | Phase 1 | United States;Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 301 | NCT00710021 | November 2008 | 16 December 2017 | Vitamin D3 in Systemic Lupus Erythematosus | Effect of Vitamin D3 on the IFN Alpha Signature in Patients With Systemic Lupus Erythematosus (ALE02) | Systemic Lupus Erythematosus;SLE;Lupus | Drug: Vitamin D3;Drug: Vitamin D3 placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Not recruiting | 18 Years | N/A | All | 57 | Phase 2 | United States |
| 302 | NCT00752999 | November 2008 | 19 February 2015 | Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus Erythematosus | A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Systemic Lupus Erythematosus Patients With Active Disease | Systemic Lupus Erythematosus | Drug: Fostamatinib Disodium (R935788);Drug: Placebo | Rigel Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 0 | Phase 2 | ||
| 303 | NCT00786409 | November 2008 | 26 February 2018 | Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women | Immunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26 | Systemic Lupus Erythematosus | Biological: Gardasil | University of Chicago | Merck Sharp & Dohme Corp. | Not recruiting | 9 Years | 26 Years | Female | 27 | N/A | United States |
| 304 | NCT00732940 | October 2008 | 19 October 2017 | Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 2, Multi-Center, Randomized, Open Label, Trial to Evaluate the Safety, Tolerability, and Biological Activity of 2 Dosing Schedules of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Belimumab 100 mg SC | Human Genome Sciences Inc. | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 56 | Phase 2 | United States;Mexico |
| 305 | NCT00779194 | October 2008 | 24 October 2016 | Prospective Study of Rapamycin for the Treatment of SLE | Prospective Study of Rapamycin for the Treatment of SLE | Systemic Lupus Erythematosus (SLE) | Drug: Rapamycin | State University of New York - Upstate Medical University | Pfizer;Pfizer | Not recruiting | 18 Years | N/A | Both | 40 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 306 | NCT00724867 | August 2008 | 19 October 2017 | A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States | A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 in the United States | Systemic Lupus Erythematosus | Biological: Belimumab 1 mg/kg;Biological: Belimumab 10 mg/kg | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 268 | Phase 3 | United States;Canada |
| 307 | EUCTR2007-002589-37-GB | 17/07/2008 | 19 March 2012 | A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 | A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease Who Participated in Study SL0007. - SL0008 | systemic lupus erythematosus MedDRA version: 9.1 Level: LLT Classification code 10042945 Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 Pharmaceutical Form: Solution for infusion INN or Proposed INN: epratuzumab CAS Number: 205923-57-5 Current Sponsor code: hLL2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | UCB Inc | Authorised | Female: yes Male: yes | 175 | Phase 2b | Hungary;United Kingdom;Belgium;Spain;Lithuania | |||
| 308 | NCT00657189 | July 2008 | 15 August 2016 | A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus | A Phase 2A , Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Dose Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Doses of MEDI-545, A Fully Human Anti-Interferon-Alpha Monoclonal Antibody, In Subjects With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic;Lupus | Drug: MEDI-545;Drug: Placebo | MedImmune LLC | Not recruiting | 18 Years | N/A | Both | 87 | Phase 2 | United States | |
| 309 | NCT02151409 | June 2008 | 16 December 2017 | Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects | A Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Trial of Anti-C5aR Antibody (NNC 0151-0000-0000) Administered by i.v. Infusion or s.c. Injection in Healthy Subjects. | Inflammation;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Healthy | Drug: NNC 0151-0000-0000;Drug: placebo | Novo Nordisk A/S | Not recruiting | 18 Years | 55 Years | Male | 60 | Phase 1 | Netherlands | |
| 310 | EUCTR2007-003621-24-FR | 29/05/2008 | 19 March 2012 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10065151 Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10065152 Term: Familial pulmonary arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10065150 Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP Pharmaceutical Form: Powder for nebuliser solution INN or Proposed INN: Aviptadil CAS Number: 40077-57-4 Other descriptive name: VIP Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Powder for nebuliser solution Route of administration of the placebo: Inhalation use | MondoGEN AG | Authorised | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 311 | EUCTR2006-005355-16-GB | 07/05/2008 | 19 March 2012 | 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 | 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 (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ocrelizumab Current Sponsor code: RO 496-4913 Other descriptive name: RhuMAb 2H7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche Ltd | Not Recruiting | Female: yes Male: yes | 423 | Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden | ||||
| 312 | EUCTR2006-005357-29-GB | 07/05/2008 | 3 April 2012 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ocrelizumab Current Sponsor code: RO 496-4913 Other descriptive name: RhuMAb 2H7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 369 | Portugal;Hungary;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;Sweden | ||||
| 313 | NCT00508898 | May 2008 | 10 August 2015 | The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria | The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria | Systemic Lupus Erythematosus;Nephritis;Proteinuria | Drug: Calcitriol;Drug: Multivitamin | Chinese University of Hong Kong | Not recruiting | 18 Years | 65 Years | Both | 0 | Phase 4 | Hong Kong | |
| 314 | NCT00611663 | May 2008 | 21 July 2016 | Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus | VACCILUP A Multicenter, Randomized Double-blind Trial Comparing Two Pneumococcal Vaccination Strategies in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Biological: Prevenar® and Pneumo23®;Biological: Placebo, Pneumo23® | Assistance Publique - Hôpitaux de Paris | Not recruiting | 18 Years | 65 Years | Both | 47 | Phase 2/Phase 3 | France | |
| 315 | NCT00712933 | May 2008 | 16 December 2017 | A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057 | A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™)a Fully Human Monoclonal Anti-BLyS Antibody in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 | Systemic Lupus Erythematosus | Drug: belimumab | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 738 | Phase 3 | Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czech Republic;France;Germany;Hong Kong;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Sweden;Taiwan;United Kingdom;Australia;China;Costa Rica |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 316 | NCT00866229 | April 2008 | 19 February 2015 | Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol Level | Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in SLE Patients With Corticosteroid Therapy and High LDL Cholesterol Level | Systemic Lupus Erythematosus;High LDL Cholesterol Level | Drug: Rosuvastatin;Drug: Simvastatin | Ramathibodi Hospital | AstraZeneca | Recruiting | 18 Years | 60 Years | Both | 140 | Phase 4 | Thailand |
| 317 | EUCTR2007-002566-35-GB | 19/03/2008 | 19 March 2012 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007 | systemic lupus erythematosus MedDRA version: 9.1 Level: LLT Classification code 10042945 Term: Systemic lupus erythematosus | Product Name: epratuzumab Product Code: CDP3194 Pharmaceutical Form: Solution for infusion INN or Proposed INN: epratuzumab CAS Number: 205923-57-5 Current Sponsor code: CDP3194 Other descriptive name: hLL2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | UCB Inc | Not Recruiting | Female: yes Male: yes | 210 | Phase 2b | Hungary;United Kingdom;Belgium;Spain;Lithuania | |||
| 318 | EUCTR2007-003698-13-GB | 06/03/2008 | 18 April 2012 | Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE) | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 14.1 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] | Product Name: Atacicept Product Code: TACI-Fc5 Pharmaceutical Form: Solution for injection INN or Proposed INN: Atacicept CAS Number: 845264-92-8 Other descriptive name: TACI-Fc5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 75-150 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | Authorised | Female: yes Male: yes | 510 | Phase 2/3 | Germany;Malaysia;Bulgaria;France;Austria;Brazil;Australia;Czech Republic;Serbia;Peru;Korea, Republic of;Greece;Croatia;United States;Philippines;Switzerland;Netherlands;Chile;Latvia;Lithuania;Israel;India;United Kingdom;Mexico;Argentina;Taiwan;Spain;Lebanon | |||
| 319 | NCT00626197 | February 2008 | 16 December 2017 | A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG) | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus Erythematosus | Lupus Nephritis;Systemic Lupus Erythematosus | Drug: corticosteroids;Drug: cyclophosphamide;Drug: mycophenolate mofetil;Drug: ocrelizumab;Drug: placebo | Genentech, Inc. | Roche Pharma AG | Not recruiting | 16 Years | N/A | All | 381 | Phase 3 | United States |
| 320 | ChiCTR-TRC-12001935 | 2008-01-12 | 18 April 2017 | 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 | Not Recruiting | 18 | 60 | Both | Treatment Group:161;control group:161; | Phase 3 study | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 321 | NCT00624338 | January 2008 | 19 October 2017 | Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE) | A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus, Systemic | Drug: Atacicept 75 mg;Drug: Atacicept 150 mg;Other: Placebo Comparator | EMD Serono | Merck KGaA | Not recruiting | 16 Years | N/A | All | 461 | Phase 2/Phase 3 | United States;Argentina;Australia;Austria;Bulgaria;Croatia;Czech Republic;France;Germany;Greece;India;Israel;Korea, Republic of;Latvia;Lebanon;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Russian Federation;Serbia;South Africa;Spain;Switzerland;Taiwan;Ukraine;United Kingdom |
| 322 | NCT00539838 | December 2007 | 16 December 2017 | 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 | Not recruiting | 16 Years | N/A | All | 33 | Phase 3 | United States |
| 323 | NCT02291588 | December 2007 | 19 February 2015 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus | A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: AMG 811;Drug: Placebo | Amgen | Not recruiting | 18 Years | 65 Years | Both | 26 | Phase 1 | ||
| 324 | EUCTR2007-004635-29-SE | 07/11/2007 | 19 March 2012 | Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301 | Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301 | Patients with Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) symptoms of the skin can be included in this study. Those patients who have a diagnosis of Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions of the skin can also be included in the study. | Product Name: ASF-1096 Cream 0.25% Pharmaceutical Form: Cream INN or Proposed INN: R-salbutamol sulphate Current Sponsor code: ASF-1096 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Cream Route of administration of the placebo: Cutaneous use Product Name: ASF-1096 Cream 0.5% Pharmaceutical Form: Cream INN or Proposed INN: R-salbutamol sulphate Current Sponsor code: ASF-1096 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Cream Route of administration of the placebo: Cutaneous use Product Name: ASF-1096 Cream 1.0% Pharmaceutical Form: Cream INN or Proposed INN: R-salbutamol sulphate Current Sponsor code: ASF-1096 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 1.0- Pharmaceutical form of the placebo: Cream Route of administration of the placebo: Cutaneous use | Astion Pharma A/S | Not Recruiting | Female: yes Male: yes | 140 | Denmark;Spain;Sweden | ||||
| 325 | NCT00611611 | October 2007 | 19 February 2015 | BLYS and IFN in SLE | BLyS and IFN Responses to Antigen Challenge in Human SLE | Systemic Lupus Erythematosus | Biological: fluzone;Biological: pneumovax | University of Alabama at Birmingham | Hospital for Special Surgery, New York | Not recruiting | 19 Years | 65 Years | Both | 39 | N/A | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 326 | NCT00739050 | September 19, 2007 | 16 December 2017 | Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED) | Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: simvastatin;Drug: Comparator: Placebo | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | Female | 4 | Phase 4 | ||
| 327 | NCT00519363 | September 2007 | 19 February 2015 | Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors | Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors. | Systemic Lupus Erythematosus | Drug: atorvastatin | The Center for Rheumatic Disease, Allergy, & Immunology | Saint Luke's Health System | Not recruiting | 18 Years | 60 Years | Female | 15 | Phase 1/Phase 2 | United States |
| 328 | EUCTR2007-004579-21-NL | 27/08/2007 | 19 March 2012 | Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus? | Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus? | systemic lupus erythematosus (SLE) SLE is a systemic autoimmune disease. MedDRA version: 9.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic | Trade Name: Influvac Pharmaceutical Form: Injection* INN or Proposed INN: Influenz virus surface antigens Other descriptive name: INFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED) Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 45- | University Medical Center Groningen | Authorised | Female: yes Male: yes | Netherlands | |||||
| 329 | NCT00479622 | August 2007 | 19 February 2015 | Study of TRU-015 in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus | A Randomized, Two-Arm, Parallel Group Study of the Safety, Pharmacokinetics, and Pharmacodynamics of TRU-015 Added to Standard Therapy in Subjects With Membranous Nephropathy Secondary to Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: TRU-015 | Wyeth is now a wholly owned subsidiary of Pfizer | Emergent Product Development Seattle LLC | Not recruiting | 18 Years | 70 Years | Both | 20 | Phase 1 | United States |
| 330 | NCT00684255 | August 2007 | 19 October 2017 | Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc) | Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc) | Systemic Lupus Erythematosus;Systemic Sclerosis | Procedure: Reduced Intensity Allogeneic Transplant;Drug: Fludarabine;Drug: Busulfan;Drug: Campath | New York Medical College | Not recruiting | 7 Years | 50 Years | All | 1 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 331 | NCT00504244 | July 2007 | 19 February 2015 | Myfortic Versus Azathioprine in Systemic Lupus Erythematosus | A Randomized, Multicenter Study to Assess the Efficacy on Diseases Activity of Enteric-coated Mycophenolate Sodium Versus Continuation of Azathioprine in Patients With Systemic Lupus Erythematosus on Azathioprine Maintenance Therapy. | Systemic Lupus Erythematosus | Drug: switch to Myfortic;Drug: continuation of azathioprine | Erasmus Medical Center | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 12 | Phase 3 | Netherlands |
| 332 | NCT00413361 | June 2007 | 19 February 2015 | The Reduction of Systemic Lupus Erythematosus Flares :Study PLUS | Study of the Reduction of Systemic Lupus Erythematosus Flares Through Adaptation of the Dosage of Hydroxychloroquine to Its Whole-blood Concentration. National Multicenter Randomized Prospective Study | Systemic Lupus Erythematosus | Drug: versus hydroxychloroquine | Assistance Publique - Hôpitaux de Paris | Sanofi-Synthelabo | Not recruiting | 18 Years | N/A | Both | 543 | Phase 4 | France |
| 333 | NCT00430677 | June 2007 | 19 October 2017 | 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 | Not recruiting | 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 | |
| 334 | NCT00482989 | June 2007 | 19 February 2015 | A Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI 545 in Patients With Systemic Lupus Erythematosus | A Phase 1b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI-545, a Fully Human Anti-Interferon-Alpha Monoclonal Antibody, in Patients With Systemic Lupus Erythematosus | Lupus | Biological: MEDI 545;Other: Placebo | MedImmune LLC | Not recruiting | 18 Years | N/A | Both | 183 | Phase 1 | United States;Argentina;Brazil;Chile;Canada | |
| 335 | EUCTR2006-005177-21-GB | 29/05/2007 | 19 March 2012 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76 | Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1 Level: LLT Classification code 10042945 Term: Systemic lupus erythematosus | Product Name: belimumab Product Code: HGS1006 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: belimumab CAS Number: 356547-88-1 Current Sponsor code: HGS1006 Other descriptive name: LymphoStat-B TM Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 120 and 400- Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of the placebo: Intravenous use | Human Genome Sciences, Inc. | Authorised | Female: yes Male: yes | 810 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 336 | JPRN-UMIN000000763 | 2007/05/01 | 2 April 2019 | Phase II study of rituximab in patients with severe systemic lupus erythematosus | Systemic lupus erythematosus | 1000 mg of rituximab on days 1, 15, 169 and 183 | Zenyaku Kogyo Co., Ltd. | Not Recruiting | 16years-old | 75years-old | Male and Female | 30 | Not selected | Japan | ||
| 337 | NCT00424476 | May 2007 | 19 October 2017 | A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg | Human Genome Sciences Inc. | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 865 | Phase 3 | Argentina;Australia;Brazil;Chile;Colombia;Hong Kong;India;Korea, Republic of;Peru;Philippines;Romania;Russian Federation;Taiwan;Bulgaria;China |
| 338 | EUCTR2005-004575-37-FR | 27/04/2007 | 19 March 2012 | A Sequential Adaptive 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). And Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (Version 2.0, Date 19-Jan-07). | A Sequential Adaptive 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). And Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (Version 2.0, Date 19-Jan-07). | IMMUNOSUPPRESSION FOR DISEASE, NOS MedDRA version: 9.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic | Product Name: Abatacept Product Code: BMS-188667 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Abatacept CAS Number: 332348-12-6 Current Sponsor code: BMS-188667 Other descriptive name: CTLA4Ig Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use Trade Name: CellCept Product Name: mycophenolate mofetil Pharmaceutical Form: Film-coated tablet INN or Proposed INN: mycophenolate mofetil CAS Number: 24280-93-1 Current Sponsor code: MMF Other descriptive name: CellCept Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- | Bristol-Myers Squibb International Corporation | Authorised | Female: yes Male: yes | 460 | Phase 2/3 | United Kingdom;Belgium;France | |||
| 339 | NCT00668330 | April 2007 | 19 February 2015 | Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus | Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus-Prevalence,Risk Factors and Treatment | Systemic Lupus Erythematosus | Drug: Ibandronate+alfacalcidol+calcium;Drug: placebo ibandronate+alfacalcidol+calcium | Chinese University of Hong Kong | Not recruiting | 18 Years | 80 Years | Female | 40 | Phase 4 | China | |
| 340 | EUCTR2006-004892-36-SE | 15/03/2007 | 19 March 2012 | An open randomized and comparative study on the efficacy and safety of additional treatment of subcutaneous immunoglobulin (Subcuvia) during cessation of Prednisolon in patients with active systemic lupus erythematosus (SLE) | An open randomized and comparative study on the efficacy and safety of additional treatment of subcutaneous immunoglobulin (Subcuvia) during cessation of Prednisolon in patients with active systemic lupus erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 9.1 Level: LLT Classification code 10040967 Term: SLE | Trade Name: Subcuvia Pharmaceutical Form: Solution for injection | Department of Rheumatology,University hospital,Lund | Authorised | Female: yes Male: yes | Sweden | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 341 | JPRN-UMIN000000639 | 2007/03/01 | 2 April 2019 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus | Systemic lupus erythematosus | IDEC-C2B8 plus oral prednisolone(tapering) 1000 mg of IDEC-C2B8 on days 1 and 15.Repeated at an interval of 6 months (Days 169 and 183). Placebo plus oral prednisolone(tapering) 1000 mg of placebo day 1 and 15.Repeated at an interval of 6 months (Days 169 and 183). | Zenyaku Kogyo Co., Ltd. | Not Recruiting | 16years-old | 75years-old | Male and Female | 150 | Not selected | Japan | ||
| 342 | NCT00432354 | March 2007 | 19 February 2015 | An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: atorvastatin | Buddhist Tzu Chi General Hospital | Pfizer | Recruiting | 16 Years | 80 Years | Both | 40 | Phase 2/Phase 3 | Taiwan | |
| 343 | NCT00698191 | March 2007 | 19 February 2015 | Mesenchymal Stem Cells Transplantation for Refractory Systemic Lupus Erythematosus (SLE) | Phase I/IIa: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells Transplantation For Refractory Systemic Lupus Erythematosus | Refractory Systemic Lupus Erythematosus | Biological: Allogeneic MSC (AlloMSC) | Nanjing Medical University | National Natural Science Foundation of China | Recruiting | 15 Years | 70 Years | Both | 20 | Phase 1/Phase 2 | China |
| 344 | NCT01322308 | March 2007 | 19 February 2015 | Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus | Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus, a Randomized, Double-blind, Placebo-controlled Clinical Trial | Systemic Lupus Erythematosus | Drug: pioglitazone;Drug: placebo | National Heart Institute, Mexico | National Council of Science and Technology, Mexico;Universidad Nacional Autonoma de Mexico | Not recruiting | 18 Years | 55 Years | Female | 30 | Phase 4 | |
| 345 | NCT01702740 | March 2007 | 19 February 2015 | A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus | A Phase 1, Double-blind, Placebo-controlled, Multiple Intravenous, Ascending-Dose Study of CNTO 136 to Evaluate Safety and Pharmacokinetics in Subjects With Cutaneous Lupus Erythematosus and to Evaluate Safety and Pharmacokinetics in a Cohort of Subjects With Systemic Lupus Erythematosus | Lupus Erythematosus, Cutaneous;Lupus Erythematosus, Systemic | Drug: 1 mg/kg CNTO 136;Drug: 4 mg/kg CNTO 136;Drug: 10 mg/kg CNTO 136;Drug: Placebo | Centocor Research & Development, Inc. | Not recruiting | 18 Years | 70 Years | Both | 49 | Phase 1 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 346 | NCT00541749 | February 2007 | 19 February 2015 | A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus | A Phase I, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: rhuMAb IFNalpha | Genentech, Inc. | Not recruiting | 18 Years | 65 Years | Both | 60 | Phase 1 | United States | |
| 347 | NCT00382837 | January 2007 | 19 February 2015 | Study of Epratuzumab in Systemic Lupus Erythematosus | A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems | Systemic Lupus Erythematosus | Drug: Epratuzumab | UCB Pharma | Not recruiting | 18 Years | N/A | Both | 0 | Phase 3 | United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Hungary;Italy;Netherlands;Slovakia;Spain;United Kingdom | |
| 348 | NCT00410384 | December 2006 | 19 October 2017 | A Study of Belimumab in Subjects With Systemic Lupus Erythematosus | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg | Human Genome Sciences Inc. | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 819 | Phase 3 | United States;Austria;Belgium;Canada;Costa Rica;Czech Republic;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Sweden;United Kingdom |
| 349 | NCT00418587 | December 2006 | 25 June 2018 | Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE) | Phase 1 Study of Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Cholecalciferol | Medical University of South Carolina | American College of Rheumatology Research and Education Foundation;National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | 85 Years | All | 18 | Phase 1 | United States |
| 350 | NCT00594932 | November 2006 | 19 February 2015 | Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis | Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis | Systemic Lupus Erythematosus;Arthritis | Drug: mycophenolate mofetil;Other: placebo;Drug: Mycophenolate mofetil | Oklahoma Medical Research Foundation | New York University School of Medicine | Not recruiting | 14 Years | 70 Years | Both | 27 | N/A | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 351 | NCT02391259 | November 2006 | 7 April 2015 | A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus | Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: AMG 557;Drug: Placebo | Amgen | Not recruiting | 18 Years | 70 Years | Both | 57 | Phase 1 | United States;United Kingdom | |
| 352 | NCT00390091 | September 2006 | 14 September 2015 | Study of LJP 394 (Abetimus Sodium) in Lupus Patients | A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: abetimus sodium (LJP 394) | La Jolla Pharmaceutical Company | Not recruiting | 12 Years | 70 Years | Both | 0 | Phase 2 | United States | |
| 353 | NCT00588393 | September 2006 | 19 February 2015 | FolateScan in Autoimmune Disease | Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases | Rheumatoid Arthritis;Osteoarthritis;Multiple Sclerosis;Crohn's Disease;Systemic Lupus Erythematosus | Drug: FolateScan (Technetium Tc 99mEC20) | Mayo Clinic | Endocyte | Not recruiting | 18 Years | N/A | Both | 75 | Phase 2 | United States |
| 354 | EUCTR2006-000674-73-HU | 11/08/2006 | 19 March 2012 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM, PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY AND EFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OF RENAL DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM, PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY AND EFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OF RENAL DISEASE | Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1 Level: LLT Classification code 10042945 Term: Systemic lupus erythematosus | Product Name: Abetimus sodium Product Code: LJP 394 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Abetimus Sodium CAS Number: 167362-48-3 Current Sponsor code: LJP 394 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | La Jolla Pharmaceutical Company | Authorised | Female: yes Male: yes | 730 | Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy | ||||
| 355 | NCT00381810 | June 22, 2006 | 16 December 2017 | A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus | An Open-label, Single-arm, Multicenter Phase II/III Extension Study to Evaluate the Safety of Rituximab Re-treatment in Subjects With Moderate to Severe Systemic Lupus Erythematosus Previously Enrolled in Protocol U2971g | Lupus Erythematosus, Systemic | Drug: Rituximab;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Diphenhydramine | Genentech, Inc. | Not recruiting | 16 Years | 75 Years | All | 31 | Phase 3 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 356 | NCT00336414 | June 2006 | 11 June 2018 | 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 | Not recruiting | 1 Year | 18 Years | All | 0 | Phase 3 | Italy | |
| 357 | NCT00371501 | June 2006 | 19 February 2015 | Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus | Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial | Atherosclerosis;Thromboembolism;Systemic Lupus Erythematosus | Drug: Rosuvastatin;Drug: placebo;Drug: aspirin | Tuen Mun Hospital | AstraZeneca | Not recruiting | 18 Years | N/A | Both | 72 | Phase 4 | Hong Kong |
| 358 | NCT00383513 | June 2006 | 19 February 2015 | Study of Epratuzumab in Systemic Lupus Erythematosus | An Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Epratuzumab | UCB Pharma | Not recruiting | 18 Years | N/A | Both | 29 | Phase 2 | United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Netherlands;Spain;United Kingdom | |
| 359 | NCT00556192 | June 2006 | 19 February 2015 | Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus Erythematosus | Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy Restore Peripheral B Cell Abnormalities in Systemic Lupus Erythematosus(SLE)? | Systemic Lupus Erythematosus | Drug: rituximab | Chinese University of Hong Kong | Not recruiting | 18 Years | 70 Years | Both | 20 | Phase 2 | China | |
| 360 | EUCTR2005-004067-30-AT | 08/05/2006 | 19 March 2012 | A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis | A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis | Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis | Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Infliximab Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Azathioprine Pharmaceutical Form: Film-coated tablet Other descriptive name: Azathioprine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Department of Rheumatology, Internal Medicine III, Medical University of Vienna | Not Recruiting | Female: yes Male: yes | 44 | Germany;Netherlands;Austria | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 361 | EUCTR2005-003957-28-IT | 02/05/2006 | 3 April 2012 | 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 | Pharmaceutical Form: Tablet INN or Proposed INN: Azathioprine CAS Number: 446-86-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Methylprednisolone CAS Number: 2921-57-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 8- Pharmaceutical Form: Tablet INN or Proposed INN: Prednisone CAS Number: 53-03-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical Form: Tablet INN or Proposed INN: Cyclophosphamide CAS Number: 6055-19-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Cyclophosphamide CAS Number: 6055-19-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- | ISTITUTO GIANNINA GASLINI | Authorised | Female: yes Male: yes | 141 | Phase 2 | Italy | |||
| 362 | EUCTR2005-003070-19-HU | 25/04/2006 | 19 March 2012 | A randomized, multicenter, parallel-group, open-label study to assess the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS, myfortic®) versus continuation of previous therapy in patients with proliferative lupus nephritis on standard maintenance therapy - Mylupus | A randomized, multicenter, parallel-group, open-label study to assess the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS, myfortic®) versus continuation of previous therapy in patients with proliferative lupus nephritis on standard maintenance therapy - Mylupus | lupus nephritis ( as part of the disease Systemic Lupus Erythematosus) | Trade Name: Myfortic Product Name: Myfortic Product Code: ERL080A Pharmaceutical Form: Tablet | Novartis Pharma Services AG | Authorised | Female: yes Male: yes | 140 | Hungary | ||||
| 363 | JPRN-C000000159 | 2006/03/01 | 2 April 2019 | Mizolibin for systemic lupus erythematosus in children(JSRDC10) | systematic lupus erythematosus | Methylprednisolone+mizoribine+prednisolone | Japanese Study Group of Renal Disease in Children(JSRDC) | Not Recruiting | 2years-old | 18years-old | Male and Female | 30 | Not selected | Japan | ||
| 364 | NCT00181298 | March 2006 | 19 February 2015 | Memantine in Systemic Lupus Erythematosus | Memantine in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Memantine;Drug: Placebo | Johns Hopkins University | Forest Laboratories | Not recruiting | 18 Years | N/A | Both | 61 | N/A | United States |
| 365 | NCT00299819 | March 2006 | 19 February 2015 | Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE) | A Phase I, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate Safety and Tolerability of a Single IV Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Patients With Systemic Lupus Erythematosus (SLE) | Lupus | Biological: MEDI-545;Biological: MEDI 545 | MedImmune LLC | Not recruiting | 18 Years | 80 Years | Both | 45 | Phase 1 | United States;Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 366 | NCT01101802 | March 2006 | 19 February 2015 | Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE) | A Prospective, Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Mycophenolate Mofetil on 'Surrogate Markers' for Atherosclerosis in Female Patients With SLE. | Systemic Lupus Erythematosus;Atherosclerosis | Drug: Mycophenolate mofetil;Drug: sugar pill | Guy's and St Thomas' NHS Foundation Trust | Institute of Child Health, University College London, London, UK. | Not recruiting | 18 Years | 60 Years | Female | 71 | Phase 4 | United Kingdom |
| 367 | NCT00297284 | February 2006 | 19 February 2015 | Memory and Attention Problems in Lupus: New Treatment Trial With Modafinil | Pilot and Feasibility Study of Modafinil Treatment to Improve Cognitive Efficiency in SLE Patients | Systemic Lupus Erythematosus | Drug: Modafinil | Hospital for Special Surgery, New York | Not recruiting | 18 Years | 60 Years | Both | 20 | N/A | United States | |
| 368 | EUCTR2005-001391-12-GB | 12/10/2005 | 19 March 2012 | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE | Systemic lupus erythematosus (SLE) MedDRA version: 7.1 Level: PT Classification code 10042945 | Product Name: edratide Product Code: TV-4710 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: edratide CAS Number: 433922-67-9 Current Sponsor code: TV-4710 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.5, 1.0, 2.5- Pharmaceutical form of the placebo: Powder and solvent for solution for injection Route of administration of the placebo: Subcutaneous use | TEVA Pharmaceutical Industries, Ltd. | Authorised | Female: yes Male: yes | 260 | Hungary;Germany;United Kingdom;Spain;Italy | ||||
| 369 | EUCTR2005-002207-16-GB | 30/09/2005 | 24 April 2012 | A randomised controlled trial of Myfortic versus Mycophenolate Mofetil in the treatment of multi-system autoimmune disease. - MYFMAD | A randomised controlled trial of Myfortic versus Mycophenolate Mofetil in the treatment of multi-system autoimmune disease. - MYFMAD | Multi-system autoimmune diseases including vasculitis and systemic lupus erythematosus (SLE) | Trade Name: Myfortic Pharmaceutical Form: Coated tablet Trade Name: Cellcept Pharmaceutical Form: Capsule* | Cambridge University Hospitals NHS Foundation Trust | Authorised | Female: yes Male: yes | 40 | United Kingdom | ||||
| 370 | NCT00278538 | September 23, 2005 | 15 April 2019 | Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus | Cyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus: Phase II Trial | Systemic Lupus Erythematosus | Biological: Hematopoietic stem cell transplantation | Northwestern University | Not recruiting | 15 Years | 60 Years | All | 33 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 371 | EUCTR2005-001688-74-GB | 22/09/2005 | 30 April 2019 | A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile) | A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile) | Atherosclerosis in patients with Systemic Lupus Erythematosis | Trade Name: CellCept Product Name: Mycophenolate mofetil Product Code: Ro 106-1443 Pharmaceutical Form: Tablet INN or Proposed INN: Mycophenolate motetil CAS Number: Ro 106-1443 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use | Guy's & St Thomas' NHS Foundation Trust | Not Recruiting | Female: yes Male: no | 100 | Phase 4 | United Kingdom | |||
| 372 | NCT00119678 | September 2005 | 19 October 2017 | 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 | Not recruiting | 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 | |
| 373 | NCT00230035 | September 2005 | 19 February 2015 | Lupus Immunosuppressive/Immunomodulatory Therapy or Stem Cell Transplant (LIST) | A Randomized, Open Label, Phase II Multicenter Study of Non-Myeloablative Autologous Transplantation With Auto-CD34+HPC Versus Currently Available Immunosuppressive/Immunomodulatory Therapy for Treatment of Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Procedure: Leukapheresis;Procedure: Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT);Procedure: Autologous CD34+HPC transplantation (HSCT);Procedure: Plasmapheresis;Drug: Rabbit anti-thymocyte globulin;Drug: Methylprednisolone;Drug: Growth colony stimulating factor (G-CSF);Drug: Corticosteroids;Drug: Mycophenolate mofetil;Drug: Azathioprine;Drug: Intravenous immunoglobulin;Drug: Methotrexate;Drug: Rituximab;Drug: Leflunomide | National Institute of Allergy and Infectious Diseases (NIAID) | Not recruiting | 18 Years | 60 Years | Both | 0 | Phase 2 | United States | |
| 374 | NCT00203151 | July 2005 | 19 February 2015 | A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus | A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Edratide for Subcutaneous Injection in Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: edratide | Teva Pharmaceutical Industries | Not recruiting | 18 Years | 65 Years | Both | 340 | Phase 2 | United States | |
| 375 | EUCTR2005-000705-59-GB | 07/06/2005 | 24 April 2012 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Pharmaceutical Form: Concentrate for solution for infusion CAS Number: 205923-57-5 Current Sponsor code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) Concentration unit: % (W/V) percent weight/volume Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | Immunomedics, Inc. | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | Hungary;Germany;United Kingdom;Spain;Italy | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 376 | EUCTR2004-004051-19-DE | 13/05/2005 | 1 May 2012 | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006). | A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006). | SYSTEMIC LUPUS ERYTHEMATOSUS, NOS | Product Name: Abatacept Product Code: BMS-188667 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Abatacept CAS Number: 332348-12-6 Current Sponsor code: BMS-188667 Other descriptive name: CTLA4Ig Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use | Bristol-Myers Squibb International Corporation | Not Recruiting | Female: yes Male: yes | 250 | Phase 2B | United Kingdom;Germany;Italy;Sweden | |||
| 377 | EUCTR2005-000706-31-GB | 13/05/2005 | 29 May 2012 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE | Systemic Lupus Erythematosus Classification code 10042945 | Product Name: Epratuzumab Product Code: IMMU-103 Pharmaceutical Form: Concentrate for solution for infusion CAS Number: 205923-57-5 Current Sponsor code: IMMU-103 Other descriptive name: hLL2 (trivial name or chemical description) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | Immunomedics, Inc. | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Germany;United Kingdom;Spain;Italy | |||
| 378 | NCT00137969 | May 10, 2005 | 26 August 2019 | 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. | Not recruiting | 16 Years | 75 Years | All | 262 | Phase 2/Phase 3 | United States;Canada | |
| 379 | NCT00583362 | May 1, 2005 | 16 December 2017 | A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02 | A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02 | Systemic Lupus Erythematosus | Biological: Belimumab | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 298 | Phase 2 | United States;Canada |
| 380 | NCT02411136 | May 2005 | 20 April 2015 | A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Multi-dose Administration in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: AMG 623;Drug: Placebo | Amgen | Not recruiting | 18 Years | 65 Years | Both | 64 | Phase 1 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 381 | NCT00113971 | April 2005 | 19 February 2015 | Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE) | A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: epratuzumab | UCB Pharma | Not recruiting | 18 Years | N/A | Both | 20 | Phase 2 | United States | |
| 382 | NCT00731302 | April 2005 | 16 December 2017 | Aspirin Resistance in Systemic Lupus Erythematosus (SLE) | Vascular Damage in Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: aspirin and meloxicam | Vanderbilt University | National Heart, Lung, and Blood Institute (NHLBI) | Not recruiting | 18 Years | N/A | All | 70 | Phase 1 | United States |
| 383 | EUCTR2004-004404-21-GB | 10/12/2004 | 21 August 2012 | Omega-3-Polyunsaturated Fatty Acids and Atherosclerosis in Systemic Lupus Erythematosus: Cellular Mechanisms and Functional Consequences - Fish oils in Lupus | Omega-3-Polyunsaturated Fatty Acids and Atherosclerosis in Systemic Lupus Erythematosus: Cellular Mechanisms and Functional Consequences - Fish oils in Lupus | Systemic Lupus Erythematosus | Trade Name: Omacor Product Name: Omacor Pharmaceutical Form: Capsule, soft INN or Proposed INN: Eicosapentaenoic acid CAS Number: 25378-27-2. Concentration unit: g gram(s) Concentration type: equal Concentration number: 1.8- INN or Proposed INN: Docosahexaenoic acid CAS Number: 25167-62-8 Concentration unit: g gram(s) Concentration type: equal Concentration number: 1.2- INN or Proposed INN: alpha-tocopherol CAS Number: 1406-18-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 16- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use | GreenPark Healthcare Trust | Queens University Belfast | Authorised | Female: yes Male: yes | 60 | United Kingdom | |||
| 384 | NCT00089804 | October 2004 | 19 February 2015 | Study of LJP 394 in Lupus Patients With History of Renal Disease | A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease | Lupus Erythematosus, Systemic;Lupus Nephritis | Drug: abetimus sodium (LJP 394) and/or placebo solution;Drug: abetimus sodium (LJP 394);Drug: Phosphate-buffered saline | La Jolla Pharmaceutical Company | Not recruiting | 12 Years | 70 Years | Both | 943 | Phase 3 | United States;Argentina;Australia;Belarus;Brazil;Bulgaria;Czech Republic;Georgia;Germany;Hong Kong;Hungary;India;Indonesia;Italy;Korea, Republic of;Lebanon;Malaysia;Mexico;Philippines;Poland;Portugal;Puerto Rico;Romania;Serbia;Slovakia;Spain;Sri Lanka;Taiwan;Thailand;Ukraine;Former Serbia and Montenegro | |
| 385 | NCT02443506 | October 2004 | 25 May 2015 | A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus | A Randomized Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Single Dose Administration in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: AMG 623;Drug: Placebo | Amgen | Not recruiting | 18 Years | 55 Years | Both | 56 | Phase 1 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 386 | NCT00094380 | September 2004 | 16 December 2017 | Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077) | Treatment of Systemic Lupus Erythematosus With CTLA4-IgG4m Plus Cyclophosphamide: A Phase I/IIA Study | Lupus Erythematosus, Systemic;Lupus Nephritis | Drug: CTLA4-IgG4m (RG2077);Drug: Cyclophosphamide | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN) | Not recruiting | 18 Years | N/A | All | 6 | Phase 1/Phase 2 | United States |
| 387 | NCT00417430 | September 2004 | 19 February 2015 | Efficacy of Faslodex in Treatment of SLE Clinical, Serologic, and Molecular Studies | Phase II Study of Efficacy of ICI 182,780 (Faslodex) in the Treatment of Systemic Lupus Erythematosus: Clinical, Serologic, Molecular | Systemic Lupus Erythematosus | Drug: ICI 182,780 (Faslodex) | The Center for Rheumatic Disease, Allergy, & Immunology | AstraZeneca | Not recruiting | 16 Years | 50 Years | Female | 20 | Phase 2 | United States |
| 388 | NCT00278590 | July 2004 | 16 December 2017 | Allogeneic Stem Cell Transplantation in Systemic Lupus Erythematosus | Allogeneic Stem Cell Transplantation in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: Allogeneic Stem Cell Transplantation | Northwestern University | Not recruiting | 18 Years | 50 Years | All | 0 | Phase 1 | United States | |
| 389 | NCT00076752 | January 30, 2004 | 16 December 2017 | Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus | A Pilot Study of Intensified Lymphodepletion Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: fludarabine phosphate;Drug: cyclophosphamide;Biological: Rituxan (rituximab);Biological: filgrastim;Drug: methylprednisolone;Other: immunologic technique;Other: laboratory biomarker analysis;Procedure: autologous hematopoietic stem cell transplantation;Drug: Diphenhydramine;Drug: Mesna | National Cancer Institute (NCI) | Not recruiting | 15 Years | 40 Years | All | 9 | Phase 2 | United States | |
| 390 | NCT00125307 | January 2004 | 10 August 2015 | Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis | Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis | Lupus Nephritis;Lupus Erythematosus, Systemic | Drug: tacrolimus | Chinese University of Hong Kong | Not recruiting | 18 Years | N/A | Both | 20 | Phase 4 | Hong Kong;China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 391 | NCT00071487 | October 2003 | 19 October 2017 | Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus, Systemic | Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 4 mg/kg;Drug: Belimumab 10 mg/kg | Human Genome Sciences Inc. | Not recruiting | 18 Years | 65 Years | All | 449 | Phase 2 | United States;Canada | |
| 392 | NCT00189124 | September 2003 | 30 May 2016 | Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) Prevention | Does DHEA Improve Endothelial Dysfunction and Other Cardiovascular Risk Factors in Premenopausal Women With Systemic Lupus? | Systemic Lupus Erythematosus | Drug: Dehydroepiandrosterone (DHEA) | University of Michigan | Arthritis Foundation | Not recruiting | 18 Years | N/A | Female | 13 | Phase 2/Phase 3 | United States |
| 393 | NCT00082511 | July 2003 | 19 February 2015 | GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids | A Multi-Center, Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment With GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids | Systemic Lupus Erythematosus | Drug: Prasterone (GL701) | Genelabs Technologies | Not recruiting | 18 Years | N/A | Female | 114 | Phase 3 | United States;Mexico | |
| 394 | NCT00124514 | June 2003 | 19 February 2015 | Triptorelin for Ovary Protection in Childhood Onset Lupus | Systemic Lupus Erythematosus | Drug: Triptorelin pamoate | Children's Hospital Medical Center, Cincinnati | Watson Pharmaceuticals | Not recruiting | 9 Years | 21 Years | Female | 30 | Phase 2 | United States;Brazil | |
| 395 | NCT00054938 | March 2003 | 19 February 2015 | Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE) | A Randomized Controlled Trial of Strategies for the Prevention of Accelerated Atherosclerosis in Systemic Lupus Erythematosus - A Pilot Study | Systemic Lupus Erythematosus;Lupus | Drug: pravastatin;Drug: aspirin;Drug: ramipril;Drug: Vitamins: B6, B12, and folate;Behavioral: heart health educational program | Brigham and Women's Hospital | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | N/A | Both | 150 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 396 | NCT00637819 | January 2003 | 19 February 2015 | Leflunomide in Systemic Lupus Erythematosus | A Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE) | Systemic Lupus Eythematosus (SLE) | Drug: Leflunomide | Sanofi | Not recruiting | 18 Years | N/A | Both | 27 | Phase 2 | Hong Kong | |
| 397 | NCT00053560 | December 2002 | 19 February 2015 | To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With Glucocorticoids | A Randomized, Double-Blind, Multi-Center, Placebo- Controlled Study to Assess Prevention of Bone Loss by Treatment With GL701 (Prestara) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids | Lupus | Drug: Prasterone (GL701) | Genelabs Technologies | Not recruiting | 18 Years | N/A | Female | 155 | Phase 3 | United States;Mexico | |
| 398 | NCT00412841 | November 2002 | 16 December 2017 | Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus | AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial | Avascular Necrosis | Drug: Atorvastatin;Procedure: MRI, Venipuncture;Drug: Placebo | New York University School of Medicine | Not recruiting | 18 Years | 75 Years | Female | 43 | Phase 2 | United States | |
| 399 | NCT00046774 | September 2, 2002 | 11 November 2019 | Monoclonal Antibody Treatment for Systemic Lupus Erythematosus | A Phase I, Open-Labeled, Dose-Ascending Clinical Trial of Immunotherapy of MRA, A Humanized Anti-IL 6 Receptor Monoclonal Antibody, In Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: MRA 003 US | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | N/A | All | 23 | Phase 1 | United States | |
| 400 | NCT00271934 | September 2002 | 19 February 2015 | Immune Ablation and Hematopoietic Stem Cell Support in Patients With Systemic Lupus Erythematosus: A Phase II Study | Immune Ablation and Hematopoietic Stem Cell Support in Patients With Poor Prognostic Indicators and Systemic Lupus Erythematosus:A Phase II Study | Systemic Lupus Erythematosus | Biological: Immune ablation and hematopoietic stem cell support. | Richard Burt, MD | Not recruiting | N/A | 60 Years | Both | 52 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 401 | NCT00120887 | April 2002 | 19 February 2015 | Lupus Atherosclerosis Prevention Study | Lupus Atherosclerosis Prevention Study | Systemic Lupus Erythematosus | Drug: Atorvastatin | Johns Hopkins University | Alliance for Lupus Research | Not recruiting | 18 Years | N/A | Both | 200 | Phase 4 | United States |
| 402 | NCT00188188 | March 2002 | 19 February 2015 | Study of Endothelial Dysfunction in Systemic Lupus and Its Role in Heart Disease | Endothelial Dysfunction in Systemic Lupus Erythematosus: Its Contribution to Abnormalities in Coronary Perfusion. | Systemic Lupus Erythematosus | Drug: quinipril | University Health Network, Toronto | Heart and Stroke Foundation of Canada | Recruiting | 20 Years | N/A | Both | 50 | Phase 4 | Canada |
| 403 | NCT00293072 | March 2002 | 19 February 2015 | Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis | Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy | Systemic Lupus Erythematosus;ANCA Associated Vasculitis | Drug: Rituximab | Cambridge University Hospitals NHS Foundation Trust | Roche Pharma AG | Not recruiting | 18 Years | 70 Years | Both | 20 | Phase 2 | United Kingdom |
| 404 | NCT00657007 | February 2002 | 19 February 2015 | Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 1, Multi-Center, Double-Blind, Single and Double Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Biological: belimumab;Biological: Placebo | Human Genome Sciences Inc. | Not recruiting | 18 Years | N/A | Both | 70 | Phase 1 | United States | |
| 405 | NCT00029926 | January 2002 | 19 February 2015 | Positron Emission Tomography (PET) to Locate Areas of White Blood Cell Activity | A Pilot Study of F-18FDG Positron Emission Tomography (PET) to Assess the Distribution of Activated Lymphocytes in Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus;Systemic | Drug: 2-deoxy-2 [F-18] fluoro-2-d-glucose | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | N/A | N/A | Both | 20 | N/A | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 406 | NCT00976300 | January 2002 | 19 February 2015 | Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study | Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study | Systemic Lupus Erythematosus;Lupus Nephritis | Drug: Cyclosporine A;Drug: Cyclophosphamide | Institute of Rheumatology, Prague | Ministry of Health, Czech Republic;Charles University, Czech Republic;Palacky University;Department of Rheumatology, Hospital, Ceske Budejovice, Czech Republic;National Institute of Rheumatology, Piestany, Slovakia;Faculty Hospital St. Anna, Brno | Not recruiting | 18 Years | 70 Years | Both | 40 | Phase 2 | Czech Republic |
| 407 | NCT00035308 | November 2001 | 19 February 2015 | Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease | Immunologic Diseases;Autoimmune Diseases;Systemic Lupus Erythematosus;Lupus Nephritis;Lupus Glomerulonephritis | Drug: Abetimus sodium (LJP 394) | La Jolla Pharmaceutical Company | Not recruiting | 12 Years | 70 Years | Both | 330 | Phase 3 | United States;Austria;Canada;France;Germany;Italy;Mexico;Spain;Sweden;United Kingdom | |
| 408 | NCT00017641 | April 2001 | 19 February 2015 | Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: filgrastim;Procedure: CD34+ Peripheral Blood Stem Cell Reinfusion | Northwestern Memorial Hospital | Not recruiting | N/A | 59 Years | Both | 10 | Phase 1 | United States | ||
| 409 | NCT00011908 | February 2001 | 19 February 2015 | Humanized LL2IGG to Treat Systemic Lupus Erythematosus | A Phase I Clinical Trial of Immunotherapy With Humanized LL2 IgG (Epratuzumab) in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: hLL2 (Epratuzumab) | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | N/A | N/A | Both | 20 | Phase 1 | United States | |
| 410 | NCT00036491 | January 2001 | 16 December 2017 | Anti-CD20 in Systemic Lupus Erythematosus | An Open-Label Safety and Efficacy Study of an Anti-CD20 Antibody (Rituximab, Rituxan®) for Anti-B Cell Therapy in the Treatment of Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: Rituximab | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Not recruiting | 18 Years | 70 Years | All | 24 | Phase 1/Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 411 | NCT00006133 | June 2000 | 19 February 2015 | Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: estradiol;Drug: ethinyl estradiol;Drug: medroxyprogesterone;Drug: norethindrone | National Center for Research Resources (NCRR) | University of Alabama at Birmingham | Not recruiting | N/A | N/A | Female | 970 | N/A | United States | |
| 412 | NCT00391924 | May 2000 | 19 February 2015 | Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome | Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration | Lupus Erythematosus, Systemic;Sjogren's Syndrome | Drug: Dehydroepiandrosterone | UMC Utrecht | University Medical Centre Groningen;Dutch Arthritis Association | Not recruiting | 18 Years | N/A | Female | 120 | Phase 2 | Netherlands |
| 413 | NCT00006055 | March 2000 | 19 February 2015 | 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 | Not recruiting | 1 Year | 55 Years | Both | 10 | N/A | United States | ||
| 414 | NCT00037128 | March 1998 | 19 February 2015 | Study of GL701 in Men With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: GL701 | Genelabs Technologies | Not recruiting | 18 Years | N/A | Male | 40 | Phase 3 | United States | ||
| 415 | NCT00001676 | January 1998 | 19 February 2015 | Cyclophosphamide and Fludarabine to Treat Lupus Nephritis | Combination of Cyclophosphamide and Fludarabine for Lupus Nephritis: Tolerance, Toxicity, Efficacy and Effects on B and T Lymphocyte Regeneration | Glomerulonephritis;Lupus Nephritis;Systemic Lupus Erythematosus | Drug: SQ Fludarabine | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | N/A | N/A | Both | 15 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 416 | NCT00392093 | November 1997 | 19 February 2015 | Effect of Hormone Replacement Therapy on Lupus Activity | Effect Of Hormone Replacement Therapy On Disease Activity, Menopausal Symptoms And Bone Mineral Density In Peri/Postmenopausal Women With Systemic Lupus Erythematosus.Randomized Clinical Trial | Systemic Lupus Erythematosus | Drug: Conjugated equine estrogens 0.625 mg/d + MPA 5 mg/d/10d | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Not recruiting | 18 Years | 65 Years | Female | 108 | Phase 4 | Mexico | |
| 417 | NCT00000421 | September 1997 | 11 April 2016 | 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) | Not recruiting | 13 Years | 65 Years | Female | 154 | Phase 2 | United States |
| 418 | NCT00000420 | June 1997 | 19 February 2015 | Safety of Estrogens in Lupus: Birth Control Pills | Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Oral Contraceptives | Systemic Lupus Erythematosus | Drug: Ortho-Novum 777 | New York University School of Medicine | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Research on Women's Health (ORWH) | Not recruiting | 18 Years | 39 Years | Female | 350 | Phase 3 | United States |
| 419 | NCT00010400 | April 1997 | 19 February 2015 | Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome | Systemic Lupus Erythematosus;Antiphospholipid Antibody Syndrome | Drug: Cyclophosphamide;Drug: filgrastim | Johns Hopkins University | Not recruiting | 18 Years | 70 Years | Both | 35 | N/A | United States | ||
| 420 | NCT00000419 | April 1996 | 19 February 2015 | Safety of Estrogens in Lupus: Hormone Replacement Therapy | Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA): Hormone Replacement Therapy | Systemic Lupus Erythematosus | Drug: Premarin and Provera | New York University School of Medicine | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Research on Women's Health (ORWH) | Not recruiting | 18 Years | 85 Years | Female | 350 | Phase 3 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 421 | NCT00004662 | March 1996 | 19 February 2015 | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: dehydroepiandrosterone | National Center for Research Resources (NCRR) | Northwestern University | Not recruiting | 18 Years | N/A | Female | 300 | Phase 3 | ||
| 422 | NCT00004665 | June 1995 | 19 February 2015 | Phase II Study of Long-Term Dehydroepiandrosterone for Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: dehydroepiandrosterone | National Center for Research Resources (NCRR) | Northwestern University | Not recruiting | 18 Years | N/A | Female | 20 | Phase 2 | ||
| 423 | NCT00470522 | June 1995 | 19 February 2015 | Study of Methotrexate in Lupus Erythematosus | A Canadian Multicenter, Randomized, Double-Blind Placebo-Controlled Study of Methotrexate and Folic Acid in Systemic Lupus Erythematosus: A Phase III Trial. | Systemic Lupus Erythematosus | Drug: Methotrexate and folic acid | University Health Network, Toronto | McGill University Health Center | Not recruiting | 18 Years | N/A | Both | 86 | Phase 3 | Canada |
| 424 | JPRN-C000000378 | 1995/03/01 | 2 April 2019 | A combination of methylprednisolone and prednisolone and a combination of Methylprednisolone, prednisolone and mizoribine for systemic lupus erythematosus in children: A randomized controlled trial of efficacy and safety izolibin for (JSRDC04) | systematic lupus erythematosus | Methylprednisolone+prednisolone Methylprednisolone+prednisolone+mizoribine | Japanese Study Group of Renal Disease in Children(JSRDC) | Not Recruiting | 2years-old | 18years-old | Male and Female | 60 | Not selected | Japan | ||
| 425 | NCT00004643 | February 1995 | 19 February 2015 | Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus | Lupus Erythematosus, Systemic | Drug: cytarabine | National Center for Research Resources (NCRR) | University of Michigan | Not recruiting | 18 Years | 64 Years | Both | 10 | Phase 2 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 426 | NCT00004795 | August 1994 | 19 February 2015 | Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: dehydroepiandrosterone | National Center for Research Resources (NCRR) | Northwestern University | Not recruiting | 18 Years | N/A | Female | 190 | Phase 2/Phase 3 | ||
| 427 | NCT00001212 | November 1986 | 19 February 2015 | 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) | Not recruiting | N/A | N/A | Both | 45 | Phase 2 | United States | |
| 428 | JPRN-JapicCTI-153064 | 16 July 2019 | TULIP | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus | Active Systemic Lupus Erythematosus | Intervention name : anifrolumab INN of the intervention : anifrolumab Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses Control intervention name : Placebo Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses | AstraZeneca | Not Recruiting | 18 | 70 | BOTH | Phase 3 | ||||
| 429 | JPRN-JapicCTI-184095 | 16 July 2019 | A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (I4V-MC-JAIA) | A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (I4V-MC-JAIA) | Systemic Lupus Erythematosus | Intervention name : LY3009104 INN of the intervention : Baricitinib Dosage And administration of the intervention : High Dose or Low Dose. Baricitinib administered orally. Placebo administered orally to maintain the blind. Control intervention name : Placebo Dosage And administration of the control intervention : Placebo administered orally. | Eli Lilly Japan K.K. | Recruiting | 18 | BOTH | Phase 3 |