13. 多発性硬化症/視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241

  
15 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2008-005021-11-BE
(EUCTR)
14/10/200912/12/2008An 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 studyAn 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, GermanyNULLNot RecruitingFemale: yes
Male: yes
68Phase 2Czech Republic;Belgium;France;Sweden
2EUCTR2008-005021-11-SE
(EUCTR)
12/08/200913/05/2009An 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 studyAn 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
250Phase 2Czech Republic;Belgium;France;Sweden
3EUCTR2008-005021-11-CZ
(EUCTR)
22/07/200908/06/2009An 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 studyAn 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
250Phase 2France;Czech Republic;Belgium;Sweden
4EUCTR2008-005021-11-FR
(EUCTR)
26/05/200924/03/2009An 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 studyAn 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 InternationalNULLNot RecruitingFemale: yes
Male: yes
250Phase 2France;Czech Republic;Belgium;Sweden
5NCT00853762
(ClinicalTrials.gov)
March 200926/2/2009Atacicept in Multiple Sclerosis Extension Study, Phase IIAn Open-label, Multicenter Phase II Extension of Study 28063 (ATAMS) to Obtain Long-term Follow-up Data in Subjects With Relapsing Multiple Sclerosis Treated With Atacicept for up to 5 Years (ATAMS-Extension)Relapsing Multiple SclerosisDrug: Atacicept 25 mg;Drug: Atacicept 75 mg;Drug: Atacicept 150 mgEMD SeronoMerck KGaATerminated18 Years60 YearsAll74Phase 2United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;New Caledonia;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom
6EUCTR2007-003936-50-GB
(EUCTR)
11/08/200813/01/2009A 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 RMSA 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. - GenevaNULLNot RecruitingFemale: yes
Male: yes
255Phase 2Netherlands;France;Austria;Lithuania;Australia;Sweden;United Kingdom;Russian Federation;Czech Republic;Canada;Ukraine;Spain;Lebanon;United States
7EUCTR2007-003936-50-LT
(EUCTR)
15/07/200820/05/2008A 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 RMSA 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-GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Sweden;Lithuania
8EUCTR2007-003936-50-AT
(EUCTR)
02/07/200810/03/2008A 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 RMSA 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. - GenevaNULLNot RecruitingFemale: yes
Male: yes
255Phase 2United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden
9EUCTR2007-003936-50-CZ
(EUCTR)
23/06/200807/04/2008A 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 RMSA 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, GermanyNULLNot RecruitingFemale: yes
Male: yes
255Phase 2United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden
10EUCTR2007-003936-50-NL
(EUCTR)
17/05/200822/01/2008A 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 RMSA 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.NULLNot RecruitingFemale: yes
Male: yes
332Phase 2United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden
11EUCTR2007-003936-50-SE
(EUCTR)
02/04/200803/03/2008A 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 RMSA 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 GermanyNULLNot RecruitingFemale: yes
Male: yes
255Phase 2United Kingdom;Czech Republic;Netherlands;France;Spain;Austria;Lithuania;Sweden
12NCT00642902
(ClinicalTrials.gov)
April 200821/3/2008A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment CourseRelapsing Multiple SclerosisDrug: Atacicept;Drug: Placebo matched to ataciceptEMD SeronoNULLTerminated18 Years60 YearsAll255Phase 2United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom
13EUCTR2007-003936-50-BE
(EUCTR)
17/03/200823/01/2008A 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 RMSA 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, GermanyNULLNot RecruitingFemale: yes
Male: yes
255Phase 2France;Czech Republic;Spain;Belgium;Lithuania;Austria;Netherlands;United Kingdom;Sweden
14EUCTR2007-003936-50-ES
(EUCTR)
10/03/200802/01/2008Estudio 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 RMSEstudio 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.NULLNot RecruitingFemale: yes
Male: yes
332Phase 2France;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;United Kingdom;Sweden
15EUCTR2007-003936-50-FR
(EUCTR)
03/03/200817/01/2008A 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 RMSA 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.NULLNot RecruitingFemale: yes
Male: yes
332Phase 2France;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;United Kingdom;Sweden