49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ChiCTR-INR-17011495 | 2017-05-25 | 2017-05-26 | Canceled by the investigator The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic sy | The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of primary mild to moderate systemic systemic lupus erythematosus | Primary mild to moderate systemic systemic lupus erythematosus | Immunomodulatory treatment group:The level of SELSNA-SLEDAI was evaluated at week 4, week 12 and week 24, the BILAG table, the SLE lesion index, and the SLE damage index were measured at 4 weeks, 12 weeks and 24 weeks. The levels of Th17, Treg and Th17 / Treg were measured.;Leflunomide treatment group:Leflunomide tablets 10m, 1 times / day, orally. The SELSNA-SLEDAI score table, BILAG worksheet, SLE damage index score were assessed at week 4, week 12 and week 24, and serum Th17, Treg and Th17 / Treg ratios were measured.;Immunomodulatory treatment group and Leflunomide treatment group :0 weeks to give prednisone acetate tablets 0.5-1mg / kg.d (or patients can choose to take the same dose of methylprednisolone tablets), 4 weeks after the beginning of the dose by 2 weeks to reduce the regular dose of 10% Reduction to prednisone acetate tablets 10mg / day to maintain.;Immunomodulatory treatment group and Leflunomide treatment group:All patients without contraindications plus hydroxychloroquine tablets 0.2,2 / day, orally; and according to the condition plus calcium (800-1200mg / day), vitamin D (200-800IU / day) and other treatment.; | The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology | NULL | Recruiting | Both | Immunomodulatory treatment group:15;Leflunomide treatment group:15;Immunomodulatory treatment group and Leflunomide treatment group :30;Immunomodulatory treatment group and Leflunomide treatment group:30; | China | |||
| 2 | JPRN-jRCTs071180052 | 26/12/2014 | 15/03/2019 | 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). | Nakashima Yasuharu | NULL | Recruiting | >= 20age old | Not applicable | Both | 150 | Phase 2 | Japan |
| 3 | JPRN-UMIN000008230 | 2014/08/01 | 22/06/2012 | 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 | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 150 | Phase 2 | Japan | |
| 4 | EUCTR2010-023645-29-DE (EUCTR) | 15/03/2011 | 11/01/2011 | 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;Term: Cutaneous lupus erythematosus | Trade Name: Fumaderm® initial Product Name: - Product Code: - INN or Proposed INN: Dimethylfumarat INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz Trade Name: Fumaderm® Product Name: - Product Code: - INN or Proposed INN: Dimethylfumarat INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz | Universitätsklinikum Münster | NULL | Not Recruiting | Female: yes Male: yes | 11 | Germany | |||
| 5 | EUCTR2006-006214-16-GB (EUCTR) | 23/02/2010 | 29/02/2008 | 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 INN or Proposed INN: ROSUVASTATIN CALCIUM Other descriptive name: rosuvastatin Trade Name: Crestor Product Name: Crestor INN or Proposed INN: ROSUVASTATIN CALCIUM Other descriptive name: rosuvastatin | Imperial College | NULL | Not Recruiting | Female: yes Male: yes | 64 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom |