49. 全身性エリテマトーデス Systemic lupus erythematosus Clinical trials / Disease details
臨床試験数 : 946 / 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 117 - 標的パスウェイ数 : 199
| 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 | EUCTR2010-019293-32-BE (EUCTR) | 10/05/2011 | 19/07/2010 | A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus) | An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany | ||
| 2 | EUCTR2010-019293-32-DE (EUCTR) | 10/02/2011 | 16/07/2010 | A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus) | An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany | |||
| 3 | NCT01240694 (ClinicalTrials.gov) | December 2010 | 15/10/2010 | A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus Erythematosus | An Open-Label Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Lupuzor | Cephalon | NULL | Terminated | 18 Years | 70 Years | All | 136 | Phase 3 | United States;Belgium;Czechia;France;Germany;Hungary;Poland;Portugal;Spain;Ukraine;United Kingdom;Czech Republic |
| 4 | EUCTR2010-018383-16-BE (EUCTR) | 10/11/2010 | 19/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | France;United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany | ||
| 5 | EUCTR2010-018383-16-PT (EUCTR) | 01/10/2010 | 23/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 13.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | France;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany | |||
| 6 | EUCTR2010-019293-32-PT (EUCTR) | 01/10/2010 | 26/07/2010 | A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus) | An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany | |||
| 7 | EUCTR2010-019293-32-ES (EUCTR) | 28/09/2010 | 21/07/2010 | Estudio abierto a largo plazo de la seguridad y la tolerabilidad de la administración repetida de CEP-33457 en pacientes con lupus eritematoso sistémico.An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Estudio abierto a largo plazo de la seguridad y la tolerabilidad de la administración repetida de CEP-33457 en pacientes con lupus eritematoso sistémico.An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Pacientes con lupus eritematoso sístemico (LES). Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: rigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Portugal;Czech Republic;Hungary;Spain;Germany | |||
| 8 | EUCTR2010-018383-16-DE (EUCTR) | 17/09/2010 | 16/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Portugal;France;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany | |||
| 9 | EUCTR2010-019293-32-CZ (EUCTR) | 19/08/2010 | 22/07/2010 | A clinical study to evaluate the tolerability of repeated doses of CEP-33457 administered in patients with a chronic autoimmune disease (Lupus) | An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Poland;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Ukraine;Germany | |||
| 10 | EUCTR2010-018383-16-HU (EUCTR) | 16/08/2010 | 20/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Portugal;Hungary;Germany;Czech Republic;Ukraine;Belgium;France;Spain;United States;Poland | |||
| 11 | EUCTR2010-019293-32-HU (EUCTR) | 16/08/2010 | 21/07/2010 | An Open-Label Long-Term Study of the Safety and Tolerability of Repeated administration of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 75 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: rigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Portugal;Hungary;Czech Republic;Spain | ||||
| 12 | EUCTR2010-018383-16-CZ (EUCTR) | 13/08/2010 | 22/07/2010 | A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus). | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | France;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany | |||
| 13 | EUCTR2010-018383-16-ES (EUCTR) | 10/08/2010 | 20/07/2010 | Estudio aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de una dosis de 200 µg de CEP-33457 en pacientes con lupus eritematoso sistémico.A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Estudio aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de una dosis de 200 µg de CEP-33457 en pacientes con lupus eritematoso sistémico.A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Pacientes con lupus eritematoso sistémico (LES). Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 13;Level: LLT;Classification code 10042945;Term: Lupus eritematoso sistémico | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: rigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | France;Portugal;Czech Republic;Hungary;Belgium;Spain;Germany | ||
| 14 | EUCTR2010-018383-16-FR (EUCTR) | 05/08/2010 | 29/07/2010 | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47 | Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: rigerimod Other descriptive name: IPP-201101, P140 | Cephalon, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Portugal;France;Czech Republic;Hungary;Spain;Belgium;Germany | ||
| 15 | NCT01135459 (ClinicalTrials.gov) | June 2010 | 1/6/2010 | A Study to Evaluate the Efficacy and Safety of CEP-33457 in Patients With Systemic Lupus Erythematosus | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Lupuzor;Drug: Placebo | Cephalon | NULL | Completed | 18 Years | 70 Years | Both | 183 | Phase 2 | United States;Belgium;Czech Republic;France;Germany;Hungary;Poland;Portugal;Spain;Ukraine;United Kingdom |