DDrare: Database of Drug Development for Rare 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	2

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	EUCTR2004-001601-10-IT (EUCTR)	19/11/2004	15/03/2007	MULTICENTTRIC, NATIONAL, SINGLE BLIND,CONTROLLED IN PARALLEL GROUP TO EVALUATE THE SAFETY AND EFFICACY OF THE SEQUENTIAL COMBINATION OF MITOXANTRONE AND BETA INTERFERON REBIF 44 mcg X 3 TIMES WEEKLY IN PATIENTS AFFECTED BY MULTIPLE SCLEROSIS, IN THE FIRST STEP OF THE DISEASE	MULTICENTTRIC, NATIONAL, SINGLE BLIND,CONTROLLED IN PARALLEL GROUP TO EVALUATE THE SAFETY AND EFFICACY OF THE SEQUENTIAL COMBINATION OF MITOXANTRONE AND BETA INTERFERON REBIF 44 mcg X 3 TIMES WEEKLY IN PATIENTS AFFECTED BY MULTIPLE SCLEROSIS, IN THE FIRST STEP OF THE DISEASE	MULTIPLE SCLEROSIS TREATMENT MedDRA version: 6.1;Level: SOC;Classification code 10029205	Trade Name: NOVANTRONEINF 2MG/ML 5ML INN or Proposed INN: Mitoxantrone Trade Name: REBIFSC 12SIR 12000000UI44MCG INN or Proposed INN: Interferon beta-1a	OSPEDALE S. RAFFAELE	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	266		France;Italy
2	NCT00203073 (ClinicalTrials.gov)	June 2003	13/9/2005	A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.	A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis.	Relapsing Remitting Multiple Sclerosis	Drug: glatiramer acetate 20 mg;Drug: glatiramer acetate 20 mg, with mitoxantrone	Teva Pharmaceutical Industries	NULL	Completed	18 Years	55 Years	Both	40	Phase 2	United States;Canada

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

EUCTR2004-001601-10-IT
(EUCTR)

19/11/2004

15/03/2007

MULTICENTTRIC, NATIONAL, SINGLE BLIND,CONTROLLED IN PARALLEL GROUP TO EVALUATE THE SAFETY AND EFFICACY OF THE SEQUENTIAL COMBINATION OF MITOXANTRONE AND BETA INTERFERON REBIF 44 mcg X 3 TIMES WEEKLY IN PATIENTS AFFECTED BY MULTIPLE SCLEROSIS, IN THE FIRST STEP OF THE DISEASE

MULTIPLE SCLEROSIS TREATMENT
MedDRA version: 6.1;Level: SOC;Classification code 10029205

Trade Name: NOVANTRONE*INF 2MG/ML 5ML
INN or Proposed INN: Mitoxantrone
Trade Name: REBIF*SC 12SIR 12000000UI44MCG
INN or Proposed INN: Interferon beta-1a

OSPEDALE S. RAFFAELE

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

266

France;Italy

NCT00203073
(ClinicalTrials.gov)

June 2003

13/9/2005

A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.

A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis.

Relapsing Remitting Multiple Sclerosis

Drug: glatiramer acetate 20 mg;Drug: glatiramer acetate 20 mg, with mitoxantrone

Teva Pharmaceutical Industries

NULL

Completed

18 Years

55 Years

Both

Phase 2

United States;Canada