Sc12267 (DrugBank: SC12267)
3 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 | 5 |
| 96 | クローン病 | 3 |
| 97 | 潰瘍性大腸炎 | 3 |
| 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 | NCT01010581 (ClinicalTrials.gov) | November 2009 | 9/11/2009 | SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-Controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: SC12267 (4SC-101);Drug: Placebo;Drug: Methotrexate;Drug: Folic Acid | 4SC AG | NULL | Completed | 18 Years | N/A | Both | 266 | Phase 2 | Bulgaria;Czech Republic;Poland;Romania |
| 2 | EUCTR2009-012953-39-PL (EUCTR) | 19/10/2009 | 31/07/2009 | A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: SC12267 Product Code: SC12267 Trade Name: Metex 2,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 7,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 10mg Tabletten INN or Proposed INN: METHOTREXATE | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | Czech Republic;Bulgaria;Poland | ||
| 3 | EUCTR2009-012953-39-BG (EUCTR) | 11/09/2009 | 18/09/2009 | A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: SC12267 Product Code: SC12267 INN or Proposed INN: Vidofludimus Trade Name: Metex 2,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 7,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 10mg Tabletten INN or Proposed INN: METHOTREXATE | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | Czech Republic;Bulgaria;Poland | ||
| 4 | EUCTR2009-012953-39-CZ (EUCTR) | 02/09/2009 | 03/07/2009 | A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: SC12267 Product Code: SC12267 Trade Name: Metex 2,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 7,5mg Tabletten INN or Proposed INN: METHOTREXATE Trade Name: Metex 10mg Tabletten INN or Proposed INN: METHOTREXATE | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 244 | Phase 2 | Czech Republic;Bulgaria;Poland | ||
| 5 | EUCTR2006-003142-42-DE (EUCTR) | 30/11/2006 | 02/02/2007 | A Randomized, Double Blind, Placebo-controlled, Proof of Concept Study to evaluate Efficacy, Safety and Pharmacokinetics of two Different Doses of SC12267 (20mg, 35 mg) in Patients with Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-controlled, Proof of Concept Study to evaluate Efficacy, Safety and Pharmacokinetics of two Different Doses of SC12267 (20mg, 35 mg) in Patients with Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 8.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: SC12267 | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany |
| 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 | EUCTR2008-005903-25-BG (EUCTR) | 23/04/2010 | 14/04/2010 | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | inflammatory bowel disease (Crohn’s disease and ulcerative colitis) MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS | Product Name: SC12267 Product Code: SC12267 Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 24 | Germany;Bulgaria | |||
| 2 | NCT00820365 (ClinicalTrials.gov) | March 2009 | 9/1/2009 | SC12267 (4SC-101) for Treatment of Patients With Inflammatory Bowel Disease | Exploratory, Open-label Study to Demonstrate Efficacy, Safety and Tolerability of SC12267 (35 mg) in Patients With Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) | Inflammatory Bowel Disease (IBD) | Drug: SC12267 (4SC-101) | 4SC AG | NULL | Completed | 18 Years | 70 Years | Both | 34 | Phase 2 | Bulgaria;Germany;Romania |
| 3 | EUCTR2008-005903-25-DE (EUCTR) | 08/01/2009 | 03/11/2008 | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | inflammatory bowel disease (Crohn’s disease and ulcerative colitis) MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS | Product Name: SC12267 Product Code: SC12267 Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 35 | Bulgaria;Germany |
| 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 | EUCTR2008-005903-25-BG (EUCTR) | 23/04/2010 | 14/04/2010 | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | inflammatory bowel disease (Crohn’s disease and ulcerative colitis) MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS | Product Name: SC12267 Product Code: SC12267 Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 24 | Germany;Bulgaria | |||
| 2 | NCT00820365 (ClinicalTrials.gov) | March 2009 | 9/1/2009 | SC12267 (4SC-101) for Treatment of Patients With Inflammatory Bowel Disease | Exploratory, Open-label Study to Demonstrate Efficacy, Safety and Tolerability of SC12267 (35 mg) in Patients With Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) | Inflammatory Bowel Disease (IBD) | Drug: SC12267 (4SC-101) | 4SC AG | NULL | Completed | 18 Years | 70 Years | Both | 34 | Phase 2 | Bulgaria;Germany;Romania |
| 3 | EUCTR2008-005903-25-DE (EUCTR) | 08/01/2009 | 03/11/2008 | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | inflammatory bowel disease (Crohn’s disease and ulcerative colitis) MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS | Product Name: SC12267 Product Code: SC12267 Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 35 | Bulgaria;Germany |