49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ChiCTR-INC-17011497 | 2017-05-25 | 2017-05-26 | Canceled by the investigator 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 | NULL | Pending | Both | Immunomodulation combined with traditional DMARDS treatment group:60;traditional DMARDS treatment group:60; | China | |||
| 2 | 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 | |||
| 3 | NCT00519363 (ClinicalTrials.gov) | September 2007 | 20/8/2007 | 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 | Completed | 18 Years | 60 Years | Female | 15 | Phase 1/Phase 2 | United States |
| 4 | NCT00432354 (ClinicalTrials.gov) | March 2007 | 6/2/2007 | 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 | |
| 5 | NCT00412841 (ClinicalTrials.gov) | November 2002 | 18/12/2006 | 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 | NYU Langone Health | NULL | Terminated | 18 Years | 75 Years | Female | 43 | Phase 2 | United States |
| 6 | NCT00120887 (ClinicalTrials.gov) | April 2002 | 12/7/2005 | Lupus Atherosclerosis Prevention Study | Lupus Atherosclerosis Prevention Study | Systemic Lupus Erythematosus | Drug: Atorvastatin | Johns Hopkins University | Alliance for Lupus Research | Completed | 18 Years | N/A | Both | 200 | Phase 4 | United States |