Remsima (ct-p13) (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 97 | 潰瘍性大腸炎 | 6 |
| 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 | EUCTR2019-003849-15-HR (EUCTR) | 05/06/2020 | 20/11/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 2 | EUCTR2019-003849-15-ES (EUCTR) | 12/05/2020 | 28/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 3 | EUCTR2019-003849-15-FR (EUCTR) | 03/04/2020 | 03/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 4 | EUCTR2019-003849-15-GR (EUCTR) | 03/04/2020 | 02/04/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany | ||
| 5 | EUCTR2019-003849-15-BG (EUCTR) | 03/04/2020 | 07/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 615 | Phase 3 | Serbia;Belarus;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Germany;Latvia;Moldova, Republic of | ||
| 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 |
| 6 | EUCTR2019-003849-15-AT (EUCTR) | 20/03/2020 | 06/02/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis | A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 615 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany |