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 | EUCTR2013-002758-62-IT (EUCTR) | 14/10/2014 | 31/03/2014 | Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II) | A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) | Systemic Lupus Erythematosus (SLE) MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 213 | Phase 2 | United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 2 | EUCTR2013-002758-62-DE (EUCTR) | 18/08/2014 | 13/03/2014 | Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II) | A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) | Systemic Lupus Erythematosus (SLE) MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 213 | Phase 2 | United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 3 | NCT02070978 (ClinicalTrials.gov) | July 29, 2014 | 21/2/2014 | Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II) | A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed Protocol EMR-700461-023 (ADDRESS II) | Lupus Erythematosus, Systemic | Drug: Atacicept 75 mg;Drug: Atacicept 150 mg | EMD Serono | NULL | Terminated | 18 Years | N/A | All | 253 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom |
| 4 | EUCTR2013-002758-62-ES (EUCTR) | 16/07/2014 | 21/07/2014 | Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II) | A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) | Systemic Lupus Erythematosus (SLE) MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 213 | Phase 2 | United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 5 | EUCTR2013-002758-62-CZ (EUCTR) | 19/06/2014 | 16/04/2014 | Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II) | A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) | Systemic Lupus Erythematosus (SLE) MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 213 | Phase 2 | United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 6 | EUCTR2013-002758-62-GB (EUCTR) | 09/05/2014 | 13/05/2014 | Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II) | A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) | Systemic Lupus Erythematosus (SLE) MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 213 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 7 | EUCTR2013-002758-62-BG (EUCTR) | 30/04/2014 | 01/04/2014 | Long-term safety and tolerability study of atacicept in patients with Systemic Lupus Erythematosus who completed protocol EMR-700461-023 (ADDRESS II) | A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II) | Systemic Lupus Erythematosus (SLE) MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 213 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 8 | EUCTR2013-002773-21-IT (EUCTR) | 25/03/2014 | 03/02/2014 | Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II) | A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) - ADDRESS II | Systemic Lupus Erythematosus (SLE) MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 9 | EUCTR2013-002773-21-GB (EUCTR) | 03/03/2014 | 15/01/2014 | Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II) | A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 10 | EUCTR2013-002773-21-ES (EUCTR) | 20/02/2014 | 22/01/2014 | Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II) | A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 11 | EUCTR2013-002773-21-CZ (EUCTR) | 20/02/2014 | 11/12/2013 | Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II) | A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 12 | EUCTR2013-002773-21-DE (EUCTR) | 17/02/2014 | 07/01/2014 | Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II) | A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of | ||
| 13 | NCT01972568 (ClinicalTrials.gov) | December 2013 | 24/10/2013 | Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus | A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus, Systemic | Drug: Atacicept 75 milligram (mg);Drug: Atacicept 150 mg;Drug: Placebo | EMD Serono | NULL | Completed | 18 Years | N/A | All | 306 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Japan;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom;Czech Republic;Ukraine |
| 14 | NCT01440231 (ClinicalTrials.gov) | February 2012 | 22/9/2011 | Atacicept Demonstrating Dose RESponSe | A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Dose-Response Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Placebo;Drug: Atacicept | EMD Serono | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2 | United States |
| 15 | EUCTR2007-003698-13-BG (EUCTR) | 29/09/2008 | 07/08/2008 | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus (SLE) MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom | ||
| 16 | EUCTR2007-003698-13-LV (EUCTR) | 15/09/2008 | 19/06/2008 | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Greece;Latvia;Austria;Lithuania | ||
| 17 | EUCTR2007-003698-13-GR (EUCTR) | 09/09/2008 | 29/10/2009 | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom | ||
| 18 | EUCTR2007-003698-13-LT (EUCTR) | 14/05/2008 | 13/03/2008 | Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE) | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus 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: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | Serbia;United States;Philippines;Taiwan;Greece;Spain;Lebanon;Israel;Chile;Switzerland;India;France;Malaysia;Peru;Australia;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany | ||
| 19 | EUCTR2007-003698-13-ES (EUCTR) | 09/05/2008 | 12/02/2008 | Estudio randomizado, doble ciego, controlado frente a placebo, prospectivo, multicéntrico, de búsqueda de dosis, en fase II/III, con atacicept subcutáneo en sujetos que recientemente han experimentado un brote de Lupus eritematoso sistémico.A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Estudio randomizado, doble ciego, controlado frente a placebo, prospectivo, multicéntrico, de búsqueda de dosis, en fase II/III, con atacicept subcutáneo en sujetos que recientemente han experimentado un brote de Lupus eritematoso sistémico.A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Lupus Eritematoso Sistémico Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono International SA, An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2;Phase 3 | France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom | ||
| 20 | EUCTR2007-003698-13-AT (EUCTR) | 30/04/2008 | 10/03/2008 | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom | ||
| 21 | EUCTR2007-003698-13-CZ (EUCTR) | 09/04/2008 | 06/02/2008 | Atacicept phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE) | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | United States;Philippines;Taiwan;Greece;Spain;Lebanon;Israel;Chile;India;France;Malaysia;Australia;Peru;Netherlands;Latvia;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany | ||
| 22 | EUCTR2007-003698-13-NL (EUCTR) | 01/04/2008 | 08/01/2008 | Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE) | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus 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: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | Serbia;United States;Philippines;Taiwan;Greece;Spain;Lebanon;Israel;Chile;Switzerland;India;France;Malaysia;Peru;Australia;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany | ||
| 23 | EUCTR2007-003698-13-GB (EUCTR) | 06/03/2008 | 13/12/2007 | Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE) | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus 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: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Philippines;Taiwan;Greece;Spain;Lebanon;Chile;Israel;Switzerland;India;France;Malaysia;Australia;Peru;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany | ||
| 24 | EUCTR2007-003698-13-FR (EUCTR) | 04/03/2008 | 28/01/2008 | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono International SA, An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2;Phase 3 | France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom | ||
| 25 | NCT00624338 (ClinicalTrials.gov) | January 2008 | 15/2/2008 | Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE) | A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE) | Lupus Erythematosus, Systemic | Drug: Atacicept 75 mg;Drug: Atacicept 150 mg;Other: Placebo Comparator | EMD Serono | Merck KGaA | Completed | 16 Years | N/A | All | 461 | Phase 2/Phase 3 | United States;Argentina;Australia;Austria;Bulgaria;Croatia;Czech Republic;France;Germany;Greece;India;Israel;Korea, Republic of;Latvia;Lebanon;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Russian Federation;Serbia;South Africa;Spain;Switzerland;Taiwan;Ukraine;United Kingdom |
| 26 | EUCTR2007-003698-13-DE (EUCTR) | 09/05/2008 | Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE) | A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III | Systemic Lupus Erythematosus 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: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 2/3 | United States;Serbia;Philippines;Taiwan;Greece;Spain;Lebanon;Chile;Israel;Switzerland;India;France;Malaysia;Australia;Peru;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany |