Group 3: ustekinumab approximately 6 mg/kg (DrugBank: Ustekinumab)
15 diseases告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
37 | 膿疱性乾癬(汎発型) | 0 |
41 | 巨細胞性動脈炎 | 0 |
46 | 悪性関節リウマチ | 0 |
49 | 全身性エリテマトーデス | 0 |
50 | 皮膚筋炎/多発性筋炎 | 0 |
53 | シェーグレン症候群 | 0 |
56 | ベーチェット病 | 0 |
65 | 原発性免疫不全症候群 | 0 |
84 | サルコイドーシス | 0 |
93 | 原発性胆汁性胆管炎[原発性胆汁性肝硬変 (~2017.3)] | 0 |
96 | クローン病 | 2 |
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 |
269 | 化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群 | 0 |
271 | 強直性脊椎炎 | 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 | NCT01369342 (ClinicalTrials.gov) | July 2011 | 7/6/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2) | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2) | Crohn's Disease;Inflammatory Bowel Disease;IBD;Colitis | Drug: Group 1: Placebo;Drug: Group 2 ustekinumab 130 mg;Drug: Group 3: ustekinumab approximately 6 mg/kg | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 99 Years | All | 640 | Phase 3 | United States;Australia;Belgium;Brazil;Bulgaria;Canada;Croatia;France;Germany;Hungary;Iceland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;South Africa;Spain;United Kingdom;Ireland |
2 | NCT01369329 (ClinicalTrials.gov) | July 2011 | 7/6/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1) | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1) | Crohn's Disease;IBD;Colitis;Inflammatory Bowel Disease | Drug: Group 2 ustekinumab 130 mg;Drug: Group 3: ustekinumab approximately 6 mg/kg;Drug: Group 1: Placebo | Janssen Research & Development, LLC | NULL | Completed | 18 Years | N/A | All | 769 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Hungary;Iceland;Ireland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Serbia;South Africa;Spain;United Kingdom |