Taci-fc5 (DrugBank: TACI-Fc5)
3 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 13 |
| 46 | 悪性関節リウマチ | 27 |
| 49 | 全身性エリテマトーデス | 10 |
| 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 | EUCTR2008-005021-11-BE (EUCTR) | 14/10/2009 | 12/12/2008 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono SA - Geneva, An affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 68 | Phase 2 | Czech Republic;Belgium;France;Sweden | ||
| 2 | EUCTR2008-005021-11-SE (EUCTR) | 12/08/2009 | 13/05/2009 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Czech Republic;Belgium;France;Sweden | ||
| 3 | EUCTR2008-005021-11-CZ (EUCTR) | 22/07/2009 | 08/06/2009 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Czech Republic;Belgium;France;Sweden | ||
| 4 | EUCTR2008-005021-11-FR (EUCTR) | 26/05/2009 | 24/03/2009 | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension) - Atacicept 28063 (RMS) extension study | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 2 | Czech Republic;Belgium;France;Sweden | ||
| 5 | EUCTR2007-003936-50-GB (EUCTR) | 11/08/2008 | 13/01/2009 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: atacicept Product Code: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | Netherlands;France;Austria;Lithuania;Australia;Sweden;United Kingdom;Russian Federation;Czech Republic;Canada;Ukraine;Spain;Lebanon;United States | ||
| 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 | EUCTR2007-003936-50-LT (EUCTR) | 15/07/2008 | 20/05/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept Product Code: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono SA-Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Sweden;Lithuania | ||
| 7 | EUCTR2007-003936-50-AT (EUCTR) | 02/07/2008 | 10/03/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden | ||
| 8 | EUCTR2007-003936-50-CZ (EUCTR) | 23/06/2008 | 07/04/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono SA - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden | ||
| 9 | EUCTR2007-003936-50-NL (EUCTR) | 17/05/2008 | 22/01/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 332 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden | ||
| 10 | EUCTR2007-003936-50-SE (EUCTR) | 02/04/2008 | 03/03/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono Geneva- an affiliate of Merck KGaA, Darmstadt Germany | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden | ||
| 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 |
| 11 | EUCTR2007-003936-50-BE (EUCTR) | 17/03/2008 | 23/01/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono SA - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 2 | France;Czech Republic;Spain;Belgium;Lithuania;Austria;Netherlands;United Kingdom;Sweden | ||
| 12 | EUCTR2007-003936-50-ES (EUCTR) | 10/03/2008 | 02/01/2008 | Estudio en fase II, multicéntrico, aleatorizado, a doble ciego, con cuatro brazos y controlado frente a placebo, para evaluar, mediante RM frecuentes, la seguridad, tolerabilidad y eficacia de tres dosis de monoterapia con atacicept en sujetos con esclerosis múltiple recidivante (EMR) durante un periodo de tratamiento de 36 semanas.A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Estudio en fase II, multicéntrico, aleatorizado, a doble ciego, con cuatro brazos y controlado frente a placebo, para evaluar, mediante RM frecuentes, la seguridad, tolerabilidad y eficacia de tres dosis de monoterapia con atacicept en sujetos con esclerosis múltiple recidivante (EMR) durante un periodo de tratamiento de 36 semanas.A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Esclerosis múltiple recidivante Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 332 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden | ||
| 13 | EUCTR2007-003936-50-FR (EUCTR) | 03/03/2008 | 17/01/2008 | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course. - Atacicept frequent MRI study in RMS | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: atacicept INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono International S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 332 | Phase 2 | United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden |
| 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 | EUCTR2007-002536-29-BG (EUCTR) | 16/10/2008 | 01/10/2008 | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - August II | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - August II | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Portugal;Finland;Germany;Czech Republic;France;Bulgaria;Spain;Italy;Greece;Poland;Austria;Sweden | ||
| 2 | EUCTR2007-002536-29-GR (EUCTR) | 03/06/2008 | 12/02/2008 | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden | ||
| 3 | EUCTR2007-002536-29-DE (EUCTR) | 08/05/2008 | 05/12/2007 | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Portugal;France;Czech Republic;Greece;Finland;Spain;Poland;Austria;Bulgaria;Germany;Italy;Sweden | ||
| 4 | EUCTR2007-003647-75-FR (EUCTR) | 01/04/2008 | 07/02/2008 | A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis | A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis | Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: rituximab | Merck Serono International | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Finland;United Kingdom;Netherlands;France;Sweden | ||
| 5 | EUCTR2007-002536-29-CZ (EUCTR) | 03/03/2008 | 16/11/2007 | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden | ||
| 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 | EUCTR2007-003647-75-NL (EUCTR) | 07/02/2008 | 29/11/2007 | A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis | A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis | Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: rituximab | Merck Serono International | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Sweden;France;Finland;United Kingdom;Netherlands | ||
| 7 | EUCTR2007-003647-75-SE (EUCTR) | 06/02/2008 | 04/12/2007 | A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis | A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis | Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: MabThera 500 mg (10 mg/ml) concentrate for solution for infusion Product Name: Rituximab INN or Proposed INN: rituximab | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Finland;United Kingdom;Netherlands;France;Sweden | ||
| 8 | EUCTR2006-004140-23-GB (EUCTR) | 04/02/2008 | 07/11/2007 | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Finland;Portugal;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden | ||
| 9 | EUCTR2007-002536-29-PT (EUCTR) | 01/02/2008 | 21/11/2007 | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Finland;Portugal;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden | ||
| 10 | EUCTR2007-002536-29-BE (EUCTR) | 01/02/2008 | 20/11/2007 | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Portugal;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Sweden | ||
| 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 |
| 11 | EUCTR2007-003647-75-FI (EUCTR) | 31/01/2008 | 19/12/2007 | A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis | A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis | Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: rituximab | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Finland;United Kingdom;Netherlands;France;Sweden | ||
| 12 | EUCTR2007-002536-29-ES (EUCTR) | 18/01/2008 | 14/02/2008 | Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, fase II de atacicept en pacientes con artritis reumatoide moderada a gravemente activa, sin tratamiento previo con anti-TNFa y con respuesta insuficiente a metrotexato.A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti-TNFa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate. - Atacicept en pacientes con AR sin tratamiento previo con anti-TNFa | Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, fase II de atacicept en pacientes con artritis reumatoide moderada a gravemente activa, sin tratamiento previo con anti-TNFa y con respuesta insuficiente a metrotexato.A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti-TNFa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate. - Atacicept en pacientes con AR sin tratamiento previo con anti-TNFa | Artritis ReumatoideRheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab | Merck Serono International | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 264 | Phase 2 | Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden | ||
| 13 | EUCTR2007-002536-29-SE (EUCTR) | 12/12/2007 | 26/10/2007 | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden | ||
| 14 | EUCTR2007-002536-29-FI (EUCTR) | 19/11/2007 | 15/10/2007 | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab | Merck Serono International | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 264 | Phase 2 | Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden | ||
| 15 | EUCTR2007-002536-29-AT (EUCTR) | 09/11/2007 | 15/10/2007 | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden | ||
| 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 |
| 16 | EUCTR2006-004140-23-FI (EUCTR) | 13/09/2007 | 23/05/2007 | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono Int, a branch of Laboratoires Serono SA, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Portugal;Finland;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden | ||
| 17 | EUCTR2006-004140-23-PT (EUCTR) | 09/07/2007 | 05/03/2007 | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden | ||
| 18 | EUCTR2006-004140-23-GR (EUCTR) | 03/07/2007 | 04/04/2007 | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 2 | Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden | ||
| 19 | EUCTR2006-004140-23-CZ (EUCTR) | 06/06/2007 | 18/12/2006 | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Bulgaria;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 20 | EUCTR2006-004140-23-SE (EUCTR) | 04/06/2007 | 03/05/2007 | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono Int, a branch ofLaboratories Serono S.A. an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden | ||
| 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 |
| 21 | EUCTR2006-004140-23-DE (EUCTR) | 31/05/2007 | 14/08/2007 | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono Int, a branch of Laboratoires Seron SA an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Portugal;Greece;Finland;Spain;Belgium;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 22 | EUCTR2006-004140-23-ES (EUCTR) | 24/04/2007 | 05/03/2007 | Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, en fase II para la determinación de la dosis de atacicept, administrado por vía subcutánea, en pacientes con artritis reumatoide y con respuesta insuficiente al tratamiento con antagonistas del TNF - Atacicept en pacientes con AR y fracaso a anti-TNF, Fase II | Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, en fase II para la determinación de la dosis de atacicept, administrado por vía subcutánea, en pacientes con artritis reumatoide y con respuesta insuficiente al tratamiento con antagonistas del TNF - Atacicept en pacientes con AR y fracaso a anti-TNF, Fase II | Pacientes con Artritis Reumatoide. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: Not applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Serono International S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 288 | Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden | |||
| 23 | EUCTR2006-004140-23-BE (EUCTR) | 10/04/2007 | 07/02/2007 | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden | ||
| 24 | EUCTR2006-004140-23-SK (EUCTR) | 02/04/2007 | 19/01/2007 | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Portugal;Slovakia;Greece;Finland;Spain;Italy;United Kingdom;Czech Republic;Belgium;Bulgaria;Netherlands;Germany;Sweden | ||
| 25 | EUCTR2006-004140-23-BG (EUCTR) | 09/03/2007 | 01/03/2007 | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 | Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 2 | Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden | ||
| 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 |
| 26 | EUCTR2006-004140-23-NL (EUCTR) | 13/12/2006 | 26/04/2007 | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA | Rheumatoid arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept Product Code: Not Applicable INN or Proposed INN: atacicept Other descriptive name: TACI-Fc5 | Merck Serono Int.a branch of Laboratoires Serono SA an affiliate of Merck KgaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden | ||
| 27 | EUCTR2007-002536-29-PL (EUCTR) | 15/01/2008 | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - Atacicept in anti-TNF alfa-naïve subjects with RA | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: Adalimumab | Merck Serono International | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Austria;Poland;Sweden |
| 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 | 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;Phase 3 | France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom | ||
| 2 | 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;Phase 3 | Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Greece;Latvia;Austria;Lithuania | ||
| 3 | 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;Phase 3 | France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom | ||
| 4 | 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;Phase 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 | ||
| 5 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 2;Phase 3 | Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Greece;Latvia;Austria;Lithuania | ||
| 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 | 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;Phase 3 | France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom | ||
| 7 | 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;Phase 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 | ||
| 8 | 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;Phase 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 | ||
| 9 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 2;Phase 3 | Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Greece;Latvia;Austria;Lithuania | ||
| 10 | 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;Phase 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 |