Yisaipu ( DrugBank: Yisaipu )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 6 |
| 271 | 強直性脊椎炎 | 2 |
46. 悪性関節リウマチ
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05424393 (ClinicalTrials.gov) | March 4, 2022 | 15/6/2022 | Real-World Study on Long-term Treatment With YISAIPU for Fujian RA Patients | Long-term Real-world Prospectiv Observational Study on Maintenance Treatment With YISAIPU, an Etanercept Biosimilar, for Patients Wih Rheumatoid Arthritis of Fujian Province of China | Rheumatoid Arthritis | Drug: YISAIPU® ( An etanercept biosimilar);Drug: csDMARDs | The First Affiliated Hospital of Xiamen University | NULL | Recruiting | 18 Years | 75 Years | All | 500 | China | |
| 2 | ChiCTR2200055292 | 2022-01-04 | 2022-01-05 | Correlation between the changes of serum cytokines and immune cell subsets levels and curative effect in patients with active rheumatoid arthritis before and after Yisaipu treatment | Correlation between the changes of serum cytokines and immune cell subsets levels and curative effect in patients with active rheumatoid arthritis before and after Yisaipu treatment | Rheumatoid Arthritis | Experimental group:Yisaipu combined with methotrexate and folic acid; | Peking University People's Hospital | NULL | Recruiting | 18 | 65 | Both | Experimental group:140; | Phase 4 | China |
| 3 | ChiCTR1900026270 | 2020-04-01 | 2019-09-28 | A prospective, multicenter, randomized, open study on the efficacy and safety of Yisaipu combined with traditional Chinese medicine for standard treatment and maintenance therapy in RA patients who failed traditional DMARDs treatment | A prospective, multicenter, randomized, open study on the efficacy and safety of Yisaipu combined with traditional Chinese medicine for standard treatment and maintenance therapy in RA patients who failed traditional DMARDs treatment | Rheumatoid arthritis | the experimental group:Subcutaneously injected 50mg per week for 24 weeks. From 24 weeks to 52 weeks, Yisaipu and TCM were maintained;the control group 1:Subcutaneously injected 50mg per week for 24 weeks. From 24 weeks to 52 weeks, Yisaipu dosage reduction combined with traditional Chinese medicine was maintained;the control group 2:Subcutaneously injected 50mg per week for 24 weeks.From 24 weeks to 52 weeks, TCM maintenance treatment; | Guang'anmen Hospital, China Academy of Chinese Medical Sciences | NULL | Pending | 18 | 65 | Both | the experimental group:40;the control group 1:30;the control group 2:30; | Phase 4 | China |
| 4 | ITMCTR1900002628 | 2020-04-01 | 2019-09-28 | A prospective, multicenter, randomized, open study on the efficacy and safety of Yisaipu combined with traditional Chinese medicine for standard treatment and maintenance therapy in RA patients who failed traditional DMARDs treatment | A prospective, multicenter, randomized, open study on the efficacy and safety of Yisaipu combined with traditional Chinese medicine for standard treatment and maintenance therapy in RA patients who failed traditional DMARDs treatment | Rheumatoid arthritis | the experimental group:Subcutaneously injected 50mg per week for 24 weeks. From 24 weeks to 52 weeks, Yisaipu and TCM were maintained;the control group 1:Subcutaneously injected 50mg per week for 24 weeks. From 24 weeks to 52 weeks, Yisaipu dosage reduction combined with traditional Chinese medicine was maintained;the control group 2:Subcutaneously injected 50mg per week for 24 weeks.From 24 weeks to 52 weeks, TCM maintenance treatment; | Guang'anmen Hospital, China Academy of Chinese Medical Sciences | NULL | Pending | 18 | 65 | Both | the experimental group:40;the control group 1:30;the control group 2:30; | Phase 4 | China |
| 5 | NCT03589833 (ClinicalTrials.gov) | May 14, 2019 | 5/7/2018 | Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RA | Effectiveness and Safety of Tumor Necrosis Factor Receptor Fusion Protein(Yisaipu) Combined With Tripterygium Wilfordii for Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Tripterygium Wilfordii;Drug: Methotrexate;Drug: Yisaipu | Peking Union Medical College Hospital | NULL | Completed | 18 Years | 65 Years | All | 504 | Phase 4 | China |
| 6 | ChiCTR1900024107 | 2010-09-29 | 2019-06-26 | A randomized, controlled, open label, multicenter clinical trial to evaluate the efficacy and safety of recombinant tumor necrosis factor receptor:Fc fusion protein (rhTNFR:Fc) with Methotrexate in active rheumatoid arthritis (ReABLE-II) | A randomized, controlled, open label, multicenter clinical trial to evaluate the efficacy and safety of recombinant tumor necrosis factor receptor:Fc fusion protein (rhTNFR:Fc) with Methotrexate in active rheumatoid arthritis (ReABLE-II) | Active Rheumatoid Arthritis | A:Treatment of Yisaipu combined with methotrexate for 52 weeks;B:Treatment of Yisaipu combined with methotrexate for the first 24 weeks and followed by methotrexate monotherapy;C:Methotrexate monotherapy for 52 weeks; | Chinese Academy of Medical Sciences & Peking Union Medical College Hospital | NULL | Completed | 18 | 60 | Both | A:30;B:30;C:30; | Phase 4 | China |
271. 強直性脊椎炎
臨床試験数 : 574 / 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
| 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 | NCT03411798 (ClinicalTrials.gov) | December 15, 2017 | 14/12/2017 | Sequential Application of Yisaipu® and DMARDs in Treating Mild-to-Moderate AS | Sequential Application of Yisaipu® and Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Treating Mild-to-Moderate Ankylosing Spondylitis: the Mid-term Follow-up Result | Ankylosing Spondylitis | Drug: Yisaipu® | Nanfang Hospital of Southern Medical University | NULL | Completed | N/A | N/A | All | 76 | Phase 4 | China |
| 2 | NCT04345458 (ClinicalTrials.gov) | March 6, 2014 | 3/4/2020 | Safety and Efficacy Study of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis | Safety and Efficacy of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis on the Basis of NSAID Therapy: A Multicenter Randomized, Double-blind, Parallel Group Phase III Trial | Ankylosing Spondylitis | Drug: prefilled liquid etanercept(Yisaipu);Drug: lyophilized etanercept powder(Yisaipu) | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | NULL | Completed | 18 Years | 65 Years | All | 640 | Phase 3 | China |