이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis (TOPIC)

2017년 1월 20일 업데이트: Sanofi

An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period

The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS).

The secondary objectives were:

  • To demonstrate the effect of teriflunomide, in comparison to placebo, on:

    • Reducing conversion to definite multiple sclerosis (DMS)
    • Reducing annualized relapse rate (ARR)
    • Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI)
    • Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS)
    • Proportion of disability-free participants as assessed by the EDSS
    • Reducing participant-reported fatigue
  • To evaluate the safety and tolerability of teriflunomide
  • To evaluate the pharmacokinetics (PK) of teriflunomide
  • Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

The study consisted of 4 periods:

  • Screening period: up to 4 weeks,
  • Placebo-controlled treatment period: up to 108 weeks (at least 24 weeks for participants who experienced conversion to CDMS),
  • Extension treatment period (without placebo-control): the extension period continued until teriflunomide was commercially available in participant's country of residence.
  • Post-treatment washout period: 4 weeks after last treatment intake.

The maximal duration of the study period per participant was expected to be 116 weeks if he/she did not continue in the extension treatment period.

연구 유형

중재적

등록 (실제)

618

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 덴마크
      • Aarhus C, 덴마크, 8000
        • Investigational Site Number 6002
      • Esbjerg, 덴마크, 6700
        • Investigational Site Number 6004
  • 독일
      • Bayreuth, 독일, 95445
        • Investigational Site Number 6801
      • Berlin, 독일, 10713
        • Investigational Site Number 6810
      • Berlin, 독일, 10785
        • Investigational Site Number 6805
      • Erbach, 독일, 64711
        • Investigational Site Number 6807
      • Essen, 독일, 45122
        • Investigational Site Number 6803
      • Hannover, 독일, 30625
        • Investigational Site Number 6809
      • Ludwigshafen, 독일, 67063
        • Investigational Site Number 6804
      • Minden, 독일, 32429
        • Investigational Site Number 6815
      • Münster, 독일, 48149
        • Investigational Site Number 6802
      • Wiesbaden, 독일, 65191
        • Investigational Site Number 6806
  • 러시아 연방
      • Kazan, 러시아 연방, 420021
        • Investigational Site Number 7907
      • Nizhny Novgorod, 러시아 연방, 603000
        • Investigational Site Number 7909
      • Nizhny Novgorod, 러시아 연방, 603076
        • Investigational Site Number 7906
      • Nizhny Novgorod, 러시아 연방, 603126
        • Investigational Site Number 7904
      • Novosibirsk, 러시아 연방, 630007
        • Investigational Site Number 7912
      • Rostov-On-Don, 러시아 연방, 344085
        • Investigational Site Number 7910
      • Smolensk, 러시아 연방, 214019
        • Investigational Site Number 7905
      • St-Petersburg, 러시아 연방, 194044
        • Investigational Site Number 7911
  • 루마니아
      • Bucuresti, 루마니아, 020125
        • Investigational Site Number 7803
      • Bucuresti, 루마니아, 050098
        • Investigational Site Number 7806
      • Cluj-Napoca, 루마니아, 400012
        • Investigational Site Number 7805
      • Cluj-Napoca, 루마니아, 400012
        • Investigational Site Number 7807
      • Timisoara, 루마니아, 300736
        • Investigational Site Number 7808
  • 리투아니아
      • Klaipeda, 리투아니아, LT-92288
        • Investigational Site Number 7402
      • Siauliai, 리투아니아, LT-76231
        • Investigational Site Number 7403
      • Vilnius, 리투아니아, LT-08661
        • Investigational Site Number 7401
  • 멕시코
      • Chihuahua, 멕시코, 31203
        • Investigational Site Number 7501
      • Guadalajara, 멕시코, 45110
        • Investigational Site Number 7502
  • 미국
    • Alabama
      • Cullman, Alabama, 미국, 35058
        • Investigational Site Number 8965
    • Arizona
      • Phoenix, Arizona, 미국, 85013-4496
        • Investigational Site Number 8954
      • Phoenix, Arizona, 미국, 85060
        • Investigational Site Number 8946
    • Colorado
      • Fort Collins, Colorado, 미국, 80528
        • Investigational Site Number 8962
    • Florida
      • Maitland, Florida, 미국, 32761
        • Investigational Site Number 8920
      • St. Petersburg, Florida, 미국, 33701
        • Investigational Site Number 8953
    • Indiana
      • Ft. Wayne, Indiana, 미국, 63104
        • Investigational Site Number 8914
      • Indianapolis, Indiana, 미국, 46256
        • Investigational Site Number 8940
    • Louisiana
      • Shreveport, Louisiana, 미국, 71103
        • Investigational Site Number 8922
    • Michigan
      • Grand Rapids, Michigan, 미국, 49503
        • Investigational Site Number 8955
      • Traverse City, Michigan, 미국, 49684
        • Investigational Site Number 8949
    • Missouri
      • St Louis, Missouri, 미국, 63104
        • Investigational Site Number 8937
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87131
        • Investigational Site Number 8951
    • New York
      • New York, New York, 미국, 10029-6574
        • Investigational Site Number 8925
    • North Carolina
      • Charlotte, North Carolina, 미국, 28204
        • Investigational Site Number 8941
    • Ohio
      • Dayton, Ohio, 미국, 45409
        • Investigational Site Number 8924
    • Tennessee
      • Round Rock, Tennessee, 미국, 78681
        • Investigational Site Number 8905
    • Vermont
      • Burlington, Vermont, 미국, 05401
        • Investigational Site Number 8930
    • Washington
      • Seattle, Washington, 미국, 98122
        • Investigational Site Number 8963
  • 불가리아
      • Pleven, 불가리아, 5800
        • Investigational Site Number 5312
      • Sofia, 불가리아, 1000
        • Investigational Site Number 5307
      • Sofia, 불가리아, 1407
        • Investigational Site Number 5304
      • Sofia, 불가리아, 1431
        • Investigational Site Number 5309
      • Sofia, 불가리아, 1527
        • Investigational Site Number 5303
      • Sofia, 불가리아, 1606
        • Investigational Site Number 5306
  • 에스토니아
      • Tallinn, 에스토니아, 10617
        • Investigational Site Number 6201
      • Tartu, 에스토니아, 50406
        • Investigational Site Number 6203
  • 영국
      • Liverpool, 영국, L9 7LJ
        • Investigational Site Number 8709
      • London, 영국, E1 1BB
        • Investigational Site Number 8701
      • London, 영국, SW17 0QT
        • Investigational Site Number 8704
      • Newcastle Upon Tyne, 영국, NE1 4LP
        • Investigational Site Number 8706
      • Nottingham, 영국, NG7 2UH
        • Investigational Site Number 8705
      • Plymouth, 영국, PL6 5BX
        • Investigational Site Number 8708
      • Salford, 영국, M6 8HD
        • Investigational Site Number 8707
      • Sheffield, 영국, S10 2JF
        • Investigational Site Number 8702
  • 오스트리아
      • Innsbruck, 오스트리아, 6020
        • Investigational Site Number 4004
      • Linz, 오스트리아, 4020
        • Investigational Site Number 4005
      • Wien, 오스트리아, 1010
        • Investigational Site Number 4001
  • 우크라이나
      • Chernihiv, 우크라이나, 14029
        • Investigational Site Number 8507
      • Dnipropetrovsk, 우크라이나, 49027
        • Investigational Site Number 8501
      • Donets'K, 우크라이나, 83099
        • Investigational Site Number 8511
      • Kharkiv, 우크라이나, 61018
        • Investigational Site Number 8506
      • Kharkiv, 우크라이나, 61178
        • Investigational Site Number 8504
      • Kiev, 우크라이나, 03110
        • Investigational Site Number 8508
      • Lutsk, 우크라이나, 43005
        • Investigational Site Number 8512
      • Lviv, 우크라이나, 79010
        • Investigational Site Number 8505
      • Poltava, 우크라이나, 36011
        • Investigational Site Number 8510
      • Vinnytsya, 우크라이나, 21005
        • Investigational Site Number 8503
      • Zaporizhzhya, 우크라이나, 69000
        • Investigational Site Number 8502
  • 체코 공화국
      • Brno, 체코 공화국, 65691
        • Investigational Site Number 5801
      • Hradec Kralove, 체코 공화국, 50005
        • Investigational Site Number 5803
      • Olomouc, 체코 공화국, 77520
        • Investigational Site Number 5804
      • Ostrava - Poruba, 체코 공화국, 70852
        • Investigational Site Number 5805
  • 칠레
      • Santiago, 칠레, 760-0746
        • Investigational Site Number 5602
      • Santiago, 칠레
        • Investigational Site Number 5601
      • Santiago, 칠레
        • Investigational Site Number 5606
      • Viña Del Mar, 칠레, 2520997
        • Investigational Site Number 5605
  • 칠면조
      • Edirne, 칠면조
        • Investigational Site Number 8304
      • Istanbul, 칠면조, 34390
        • Investigational Site Number 8309
      • Istanbul, 칠면조, 34400
        • Investigational Site Number 8315
      • Istanbul, 칠면조
        • Investigational Site Number 8308
      • Istanbul, 칠면조
        • Investigational Site Number 8310
      • Istanbul, 칠면조
        • Investigational Site Number 8312
      • Izmir, 칠면조, 35100
        • Investigational Site Number 8305
      • Izmir, 칠면조, 35340
        • Investigational Site Number 8301
      • Izmir, 칠면조, 35380
        • Investigational Site Number 8303
      • Izmit, 칠면조, 41380
        • Investigational Site Number 8302
      • Trabzon, 칠면조, 61080
        • Investigational Site Number 8314
  • 캐나다
      • Greenfield Park, 캐나다, J4V 2J2
        • Investigational Site Number 5402
      • London, 캐나다, N6A 5A5
        • Investigational Site Number 5403
      • Montreal, 캐나다, H1T 2M4
        • Investigational Site Number 5409
      • Ottawa, 캐나다, K1H 8L6
        • Investigational Site Number 5401
      • Quebec, 캐나다, G1J 1Z4
        • Investigational Site Number 5406
      • Sherbrooke, 캐나다, J1H 5N4
        • Investigational Site Number 5408
      • Toronto, 캐나다, M4N 3M5
        • Investigational Site Number 5410
      • Toronto, 캐나다, M5B 1W8
        • Investigational Site Number 5404
  • 폴란드
      • Gdansk, 폴란드, 80-803
        • Investigational Site Number 7709
      • Lodz, 폴란드, 93-513
        • Investigational Site Number 7710
      • Warszawa, 폴란드, 02-097
        • Investigational Site Number 7701
      • Warszawa, 폴란드, 02-957
        • Investigational Site Number 7703
      • Warszawa 44, 폴란드, 04-141
        • Investigational Site Number 7707
  • 프랑스
      • Besancon, 프랑스, 25030
        • Investigational Site Number 6611
      • Clermont Ferrand Cedex 1, 프랑스, 63003
        • Investigational Site Number 6601
      • Lille Cedex, 프랑스, 59037
        • Investigational Site Number 6609
      • Montpellier Cedex 05, 프랑스, 34295
        • Investigational Site Number 6604
      • Nancy Cedex, 프랑스, 54036
        • Investigational Site Number 6612
      • Nantes Cedex 01, 프랑스, 44093
        • Investigational Site Number 6605
      • Nice Cedex, 프랑스, 06002
        • Investigational Site Number 6602
      • Nimes, 프랑스, 30029
        • Investigational Site Number 6614
      • Strasbourg Cedex, 프랑스, 67091
        • Investigational Site Number 6607
  • 핀란드
      • Helsinki, 핀란드, 00100
        • Investigational Site Number 6405
      • Kuopio, 핀란드, 70210
        • Investigational Site Number 6403
      • Turku, 핀란드, 20100
        • Investigational Site Number 6401
  • 헝가리
      • Budapest, 헝가리, 1076
        • Investigational Site Number 7101
      • Budapest, 헝가리, 1145
        • Investigational Site Number 7103
      • Esztergom, 헝가리, 2500
        • Investigational Site Number 7108
      • Veszprém, 헝가리, 8200
        • Investigational Site Number 7105
  • 호주
      • Geelong, 호주, 3220
        • Investigational Site Number 1405
      • Heidelberg, 호주, 3081
        • Investigational Site Number 1404
      • Hobart, 호주, 7001
        • Investigational Site Number 1407
      • Parkville, 호주, 3050
        • Investigational Site Number 1401

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • First acute or subacute, well-defined neurological event consistent with demyelination (that is, optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes)
  • Onset of MS symptoms occurring within 90 days of randomization
  • A screening MRI scan with 2 or more T2 lesions at least 3 millimeter (mm) in diameter that are characteristic of MS

Exclusion Criteria:

  • Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease
  • Significantly impaired bone marrow function
  • Pregnancy or nursing
  • Alcohol or drug abuse
  • Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment
  • Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Placebo/Teriflunomide 7 mg or Teriflunomide 14 mg

Core treatment period: Placebo matched to teriflunomide tablet once daily orally.

Extension treatment period: Re-randomized in 1:1 ratio to either teriflunomide 7 mg or 14 mg once daily orally.
의약품: Teriflunomide
Film-coated tablet Oral administration
다른 이름들:
  • 오바지오
  • HMR1726
의약품: Placebo
Film-coated tablet Oral administration
실험적: Teriflunomide 7 mg/7 mg

Core treatment period: Teriflunomide 7 mg tablet once daily orally.

Extension treatment period: Teriflunomide 7 mg tablet once daily orally.
의약품: Teriflunomide
Film-coated tablet Oral administration
다른 이름들:
  • 오바지오
  • HMR1726
실험적: Teriflunomide 14 mg/14 mg

Core treatment period: Teriflunomide 14 mg tablet once daily orally.

Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
의약품: Teriflunomide
Film-coated tablet Oral administration
다른 이름들:
  • 오바지오
  • HMR1726

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Core Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS)
기간: Up to a maximum of 108 weeks depending on time of enrollment
Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.
Up to a maximum of 108 weeks depending on time of enrollment

2차 결과 측정

결과 측정
측정값 설명
기간
Core Treatment Period: Time to Conversion to Definite Multiple Sclerosis (DMS)
기간: Up to a maximum of 108 weeks depending on time of enrollment
Conversion to DMS was demonstrated by dissemination of MRI lesions in time (as per McDonald criteria) or a relapse, whichever occurs first. MRI Imaging criteria were detection of Gadolinium (Gd) enhancement at least 3 months after onset of initial clinical event, if not at site corresponding to initial event; detection of new T2 lesion if it appears at any time compared with reference scan (done at time of screening) done at least 30 days after onset of the initial clinical event. Occurrence of relapse was defined as new neurological abnormality separated by at least 30 days from onset of preceding clinical event, present for at least 24 hours and occurring in absence of fever or known infection. New clinical abnormality (neurological sign) that is consistent with participant's symptoms with increase in at least one Functional System (FS) or EDSS score compared to last EDSS assessment. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.
Up to a maximum of 108 weeks depending on time of enrollment
Core Treatment Period: Annualized Relapse Rate (ARR)
기간: Up to a maximum of 108 weeks depending on time of enrollment
ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in EDSS score or Functional System scores. ARR was assessed using Poisson regression model with robust error variance. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses onset between randomization date and last dose date as the response variable, treatment, region and baseline monofocal/multifocal status as covariates, and log-transformed treatment duration as an offset variable).
Up to a maximum of 108 weeks depending on time of enrollment
Core Treatment Period: Brain Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Lesion Volume at Week 108
기간: Baseline, Week 108
The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.
Baseline, Week 108
Core Treatment Period: Brain MRI Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan (Poisson Regression Estimates)
기간: Up to a maximum of 108 weeks depending on time of enrollment
Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).
Up to a maximum of 108 weeks depending on time of enrollment
Core Treatment Period: Brain MRI Assessment: Volume of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan
기간: Up to a maximum of 108 weeks depending on time of enrollment
Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).
Up to a maximum of 108 weeks depending on time of enrollment
Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of Hypointense Post-Gadolinium T1 Lesion Component
기간: Baseline, Week 108
Volume of hypointense post-gadolinium T1 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction
Baseline, Week 108
Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of T2 Lesion Component
기간: Baseline, Week 108
Volume of T2 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction.
Baseline, Week 108
Core Treatment Period: Brain MRI Assessment: Percent Change From Baseline in Atrophy
기간: Baseline, Week 108
Atrophy was measured by MRI scan.
Baseline, Week 108
Core Treatment Period: Time to 12-Week Sustained Disability Progression
기간: Up to a maximum of 108 weeks depending on time of enrollment
The 12-week sustained disability progression was defined as increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score of greater than [>] 5.5) that persisted for at least 12 weeks. Percent probability of participants free of 12-week sustained disability progression at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.
Up to a maximum of 108 weeks depending on time of enrollment
Core Treatment Period: Change From Baseline in EDSS at Week 108
기간: Baseline, Week 108
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction
Baseline, Week 108
Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 108
기간: Baseline, Week 108
FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social. FIS total score ranges from 0 (no problem) to 160 (extreme problem). Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data adjusted for or baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction.
Baseline, Week 108
Core Treatment Period: Overview of Adverse Events (AEs)
기간: From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first
AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS)
기간: From randomization in the core period up to 390 Weeks (Extension treatment period [maximum exposure: 283 Weeks])
Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion was estimated using Kaplan-Meier method.
From randomization in the core period up to 390 Weeks (Extension treatment period [maximum exposure: 283 Weeks])
Extension Treatment Period: Overview of Adverse Events (AEs)
기간: From re-randomization up to 283 Weeks
AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. Safety population included all randomized population who actually received at least 1 dose of the IMP in extension and analyzed according to the treatment actually received in core study followed by treatment actually received in the extension treatment period.
From re-randomization up to 283 Weeks

기타 결과 측정

결과 측정
측정값 설명
기간
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)
기간: From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first

PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.

Hepatic parameters thresholds were defined as follows:

  • Alanine Aminotransferase (ALT) >3, 5, 10 or 20 upper limit of normal(ULN);
  • Aspartate aminotransferase (AST) >3, 5, 10 or 20 ULN;
  • Alkaline Phosphatase >1.5 ULN;
  • Total Bilirubin (TB) >1.5, 2, or 3 ULN;
  • ALT >3 ULN and TB >2 ULN.
From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first

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스폰서

Sanofi

간행물 및 유용한 링크

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2008년 2월 1일

기본 완료 (실제)

2012년 12월 1일

연구 완료 (실제)

2016년 2월 1일

연구 등록 날짜

최초 제출

2008년 2월 14일

QC 기준을 충족하는 최초 제출

2008년 2월 22일

처음 게시됨 (추정)

2008년 2월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 3월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 1월 20일

마지막으로 확인됨

2017년 1월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • EFC6260
  • HMR1726D-3005 (기타 식별자: HMR)
  • 2006-001152-12 (EudraCT 번호)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

다발성 경화증에 대한 임상 시험

Teriflunomide에 대한 임상 시험

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스폰서 및 공동 작업자

건강 상태

약물 개입

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CROs in Ukraine

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약물 개입

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스폰서 / 협력자

위치

3
구독하다