Sait101 (rituximab biosimilar) (DrugBank: Rituximab)
47 diseases告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
11 | 重症筋無力症 | 0 |
13 | 多発性硬化症/視神経脊髄炎 | 0 |
14 | 慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー | 0 |
17 | 多系統萎縮症 | 0 |
19 | ライソゾーム病 | 0 |
35 | 天疱瘡 | 0 |
36 | 表皮水疱症 | 0 |
41 | 巨細胞性動脈炎 | 0 |
42 | 結節性多発動脈炎 | 0 |
43 | 顕微鏡的多発血管炎 | 0 |
44 | 多発血管炎性肉芽腫症 | 0 |
45 | 好酸球性多発血管炎性肉芽腫症 | 0 |
46 | 悪性関節リウマチ | 3 |
49 | 全身性エリテマトーデス | 0 |
50 | 皮膚筋炎/多発性筋炎 | 0 |
51 | 全身性強皮症 | 0 |
52 | 混合性結合組織病 | 0 |
53 | シェーグレン症候群 | 0 |
55 | 再発性多発軟骨炎 | 0 |
56 | ベーチェット病 | 0 |
60 | 再生不良性貧血 | 0 |
61 | 自己免疫性溶血性貧血 | 0 |
63 | 特発性血小板減少性紫斑病 | 0 |
64 | 血栓性血小板減少性紫斑病 | 0 |
65 | 原発性免疫不全症候群 | 0 |
66 | IgA腎症 | 0 |
83 | アジソン病 | 0 |
84 | サルコイドーシス | 0 |
85 | 特発性間質性肺炎 | 0 |
86 | 肺動脈性肺高血圧症 | 0 |
93 | 原発性胆汁性胆管炎[原発性胆汁性肝硬変 (~2017.3)] | 0 |
94 | 原発性硬化性胆管炎 | 0 |
96 | クローン病 | 0 |
97 | 潰瘍性大腸炎 | 0 |
162 | 類天疱瘡(後天性表皮水疱症を含む。) | 0 |
222 | 一次性ネフローゼ症候群 | 0 |
229 | 肺胞蛋白症(自己免疫性又は先天性) | 0 |
256 | 筋型糖原病 | 0 |
271 | 強直性脊椎炎 | 0 |
274 | 骨形成不全症 | 0 |
283 | 後天性赤芽球癆 | 0 |
284 | ダイアモンド・ブラックファン貧血 | 0 |
285 | ファンコニ貧血 | 0 |
288 | 自己免疫性後天性凝固因子欠乏症[自己免疫性出血病XIII (~2017.3)] | 0 |
296 | 胆道閉鎖症 | 0 |
300 | IgG4関連疾患 | 0 |
331 | 特発性多中心性キャッスルマン病 | 0 |
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 | EUCTR2014-005368-13-IT (EUCTR) | 10/05/2017 | 16/02/2018 | A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). - A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA) | Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB | ARCHIGEN BIOTECH LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 282 | Phase 1;Phase 3 | United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of | ||
2 | EUCTR2014-005368-13-ES (EUCTR) | 23/09/2016 | 15/07/2016 | A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). | Severe Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB | Archigen Biotech Limited | NULL | Not Recruiting | Female: yes Male: yes | 282 | Phase 1;Phase 3 | United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of | ||
3 | EUCTR2014-005368-13-HU (EUCTR) | 19/09/2016 | 11/07/2016 | A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). | Severe Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan® INN or Proposed INN: RITUXIMAB | Archigen Biotech Limited | NULL | Not Recruiting | Female: yes Male: yes | 282 | Phase 1;Phase 3 | India;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of;United States;Spain;Russian Federation;Italy |