このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2017年1月20日 更新者：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

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

618

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Alabama
      • Cullman、Alabama、アメリカ、35058
        • Investigational Site Number 8965
    • Arizona
      • Phoenix、Arizona、アメリカ、85013-4496
        • Investigational Site Number 8954
      • Phoenix、Arizona、アメリカ、85060
        • Investigational Site Number 8946
    • Colorado
      • Fort Collins、Colorado、アメリカ、80528
        • Investigational Site Number 8962
    • Florida
      • Maitland、Florida、アメリカ、32761
        • Investigational Site Number 8920
      • St. Petersburg、Florida、アメリカ、33701
        • Investigational Site Number 8953
    • Indiana
      • Ft. Wayne、Indiana、アメリカ、63104
        • Investigational Site Number 8914
      • Indianapolis、Indiana、アメリカ、46256
        • Investigational Site Number 8940
    • Louisiana
      • Shreveport、Louisiana、アメリカ、71103
        • Investigational Site Number 8922
    • Michigan
      • Grand Rapids、Michigan、アメリカ、49503
        • Investigational Site Number 8955
      • Traverse City、Michigan、アメリカ、49684
        • Investigational Site Number 8949
    • Missouri
      • St Louis、Missouri、アメリカ、63104
        • Investigational Site Number 8937
    • New Mexico
      • Albuquerque、New Mexico、アメリカ、87131
        • Investigational Site Number 8951
    • New York
      • New York、New York、アメリカ、10029-6574
        • Investigational Site Number 8925
    • North Carolina
      • Charlotte、North Carolina、アメリカ、28204
        • Investigational Site Number 8941
    • Ohio
      • Dayton、Ohio、アメリカ、45409
        • Investigational Site Number 8924
    • Tennessee
      • Round Rock、Tennessee、アメリカ、78681
        • Investigational Site Number 8905
    • Vermont
      • Burlington、Vermont、アメリカ、05401
        • Investigational Site Number 8930
    • Washington
      • Seattle、Washington、アメリカ、98122
        • Investigational Site Number 8963
  • イギリス
      • Liverpool、イギリス、L9 7LJ
        • Investigational Site Number 8709
      • London、イギリス、E1 1BB
        • Investigational Site Number 8701
      • London、イギリス、SW17 0QT
        • Investigational Site Number 8704
      • Newcastle Upon Tyne、イギリス、NE1 4LP
        • Investigational Site Number 8706
      • Nottingham、イギリス、NG7 2UH
        • Investigational Site Number 8705
      • Plymouth、イギリス、PL6 5BX
        • Investigational Site Number 8708
      • Salford、イギリス、M6 8HD
        • Investigational Site Number 8707
      • Sheffield、イギリス、S10 2JF
        • Investigational Site Number 8702
  • ウクライナ
      • Chernihiv、ウクライナ、14029
        • Investigational Site Number 8507
      • Dnipropetrovsk、ウクライナ、49027
        • Investigational Site Number 8501
      • Donets'K、ウクライナ、83099
        • Investigational Site Number 8511
      • Kharkiv、ウクライナ、61018
        • Investigational Site Number 8506
      • Kharkiv、ウクライナ、61178
        • Investigational Site Number 8504
      • Kiev、ウクライナ、03110
        • Investigational Site Number 8508
      • Lutsk、ウクライナ、43005
        • Investigational Site Number 8512
      • Lviv、ウクライナ、79010
        • Investigational Site Number 8505
      • Poltava、ウクライナ、36011
        • Investigational Site Number 8510
      • Vinnytsya、ウクライナ、21005
        • Investigational Site Number 8503
      • Zaporizhzhya、ウクライナ、69000
        • Investigational Site Number 8502
  • エストニア
      • Tallinn、エストニア、10617
        • Investigational Site Number 6201
      • Tartu、エストニア、50406
        • Investigational Site Number 6203
  • オーストラリア
      • Geelong、オーストラリア、3220
        • Investigational Site Number 1405
      • Heidelberg、オーストラリア、3081
        • Investigational Site Number 1404
      • Hobart、オーストラリア、7001
        • Investigational Site Number 1407
      • Parkville、オーストラリア、3050
        • Investigational Site Number 1401
  • オーストリア
      • Innsbruck、オーストリア、6020
        • Investigational Site Number 4004
      • Linz、オーストリア、4020
        • Investigational Site Number 4005
      • Wien、オーストリア、1010
        • Investigational Site Number 4001
  • カナダ
      • Greenfield Park、カナダ、J4V 2J2
        • Investigational Site Number 5402
      • London、カナダ、N6A 5A5
        • Investigational Site Number 5403
      • Montreal、カナダ、H1T 2M4
        • Investigational Site Number 5409
      • Ottawa、カナダ、K1H 8L6
        • Investigational Site Number 5401
      • Quebec、カナダ、G1J 1Z4
        • Investigational Site Number 5406
      • Sherbrooke、カナダ、J1H 5N4
        • Investigational Site Number 5408
      • Toronto、カナダ、M4N 3M5
        • Investigational Site Number 5410
      • Toronto、カナダ、M5B 1W8
        • Investigational Site Number 5404
  • チェコ共和国
      • Brno、チェコ共和国、65691
        • Investigational Site Number 5801
      • Hradec Kralove、チェコ共和国、50005
        • Investigational Site Number 5803
      • Olomouc、チェコ共和国、77520
        • Investigational Site Number 5804
      • Ostrava - Poruba、チェコ共和国、70852
        • Investigational Site Number 5805
  • チリ
      • Santiago、チリ、760-0746
        • Investigational Site Number 5602
      • Santiago、チリ
        • Investigational Site Number 5601
      • Santiago、チリ
        • Investigational Site Number 5606
      • Viña Del Mar、チリ、2520997
        • Investigational Site Number 5605
  • デンマーク
      • Aarhus C、デンマーク、8000
        • Investigational Site Number 6002
      • Esbjerg、デンマーク、6700
        • Investigational Site Number 6004
  • ドイツ
      • Bayreuth、ドイツ、95445
        • Investigational Site Number 6801
      • Berlin、ドイツ、10713
        • Investigational Site Number 6810
      • Berlin、ドイツ、10785
        • Investigational Site Number 6805
      • Erbach、ドイツ、64711
        • Investigational Site Number 6807
      • Essen、ドイツ、45122
        • Investigational Site Number 6803
      • Hannover、ドイツ、30625
        • Investigational Site Number 6809
      • Ludwigshafen、ドイツ、67063
        • Investigational Site Number 6804
      • Minden、ドイツ、32429
        • Investigational Site Number 6815
      • Münster、ドイツ、48149
        • Investigational Site Number 6802
      • Wiesbaden、ドイツ、65191
        • Investigational Site Number 6806
  • ハンガリー
      • Budapest、ハンガリー、1076
        • Investigational Site Number 7101
      • Budapest、ハンガリー、1145
        • Investigational Site Number 7103
      • Esztergom、ハンガリー、2500
        • Investigational Site Number 7108
      • Veszprém、ハンガリー、8200
        • Investigational Site Number 7105
  • フィンランド
      • Helsinki、フィンランド、00100
        • Investigational Site Number 6405
      • Kuopio、フィンランド、70210
        • Investigational Site Number 6403
      • Turku、フィンランド、20100
        • Investigational Site Number 6401
  • フランス
      • Besancon、フランス、25030
        • Investigational Site Number 6611
      • Clermont Ferrand Cedex 1、フランス、63003
        • Investigational Site Number 6601
      • Lille Cedex、フランス、59037
        • Investigational Site Number 6609
      • Montpellier Cedex 05、フランス、34295
        • Investigational Site Number 6604
      • Nancy Cedex、フランス、54036
        • Investigational Site Number 6612
      • Nantes Cedex 01、フランス、44093
        • Investigational Site Number 6605
      • Nice Cedex、フランス、06002
        • Investigational Site Number 6602
      • Nimes、フランス、30029
        • Investigational Site Number 6614
      • Strasbourg Cedex、フランス、67091
        • Investigational Site Number 6607
  • ブルガリア
      • Pleven、ブルガリア、5800
        • Investigational Site Number 5312
      • Sofia、ブルガリア、1000
        • Investigational Site Number 5307
      • Sofia、ブルガリア、1407
        • Investigational Site Number 5304
      • Sofia、ブルガリア、1431
        • Investigational Site Number 5309
      • Sofia、ブルガリア、1527
        • Investigational Site Number 5303
      • Sofia、ブルガリア、1606
        • Investigational Site Number 5306
  • ポーランド
      • Gdansk、ポーランド、80-803
        • Investigational Site Number 7709
      • Lodz、ポーランド、93-513
        • Investigational Site Number 7710
      • Warszawa、ポーランド、02-097
        • Investigational Site Number 7701
      • Warszawa、ポーランド、02-957
        • Investigational Site Number 7703
      • Warszawa 44、ポーランド、04-141
        • Investigational Site Number 7707
  • メキシコ
      • Chihuahua、メキシコ、31203
        • Investigational Site Number 7501
      • Guadalajara、メキシコ、45110
        • Investigational Site Number 7502
  • リトアニア
      • Klaipeda、リトアニア、LT-92288
        • Investigational Site Number 7402
      • Siauliai、リトアニア、LT-76231
        • Investigational Site Number 7403
      • Vilnius、リトアニア、LT-08661
        • Investigational Site Number 7401
  • ルーマニア
      • Bucuresti、ルーマニア、020125
        • Investigational Site Number 7803
      • Bucuresti、ルーマニア、050098
        • Investigational Site Number 7806
      • Cluj-Napoca、ルーマニア、400012
        • Investigational Site Number 7805
      • Cluj-Napoca、ルーマニア、400012
        • Investigational Site Number 7807
      • Timisoara、ルーマニア、300736
        • Investigational Site Number 7808
  • ロシア連邦
      • Kazan、ロシア連邦、420021
        • Investigational Site Number 7907
      • Nizhny Novgorod、ロシア連邦、603000
        • Investigational Site Number 7909
      • Nizhny Novgorod、ロシア連邦、603076
        • Investigational Site Number 7906
      • Nizhny Novgorod、ロシア連邦、603126
        • Investigational Site Number 7904
      • Novosibirsk、ロシア連邦、630007
        • Investigational Site Number 7912
      • Rostov-On-Don、ロシア連邦、344085
        • Investigational Site Number 7910
      • Smolensk、ロシア連邦、214019
        • Investigational Site Number 7905
      • St-Petersburg、ロシア連邦、194044
        • Investigational Site Number 7911
  • 七面鳥
      • Edirne、七面鳥
        • Investigational Site Number 8304
      • Istanbul、七面鳥、34390
        • Investigational Site Number 8309
      • Istanbul、七面鳥、34400
        • Investigational Site Number 8315
      • Istanbul、七面鳥
        • Investigational Site Number 8308
      • Istanbul、七面鳥
        • Investigational Site Number 8310
      • Istanbul、七面鳥
        • Investigational Site Number 8312
      • Izmir、七面鳥、35100
        • Investigational Site Number 8305
      • Izmir、七面鳥、35340
        • Investigational Site Number 8301
      • Izmir、七面鳥、35380
        • Investigational Site Number 8303
      • Izmit、七面鳥、41380
        • Investigational Site Number 8302
      • Trabzon、七面鳥、61080
        • Investigational Site Number 8314

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～55年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：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.
薬：Teriflunomide
Film-coated tablet Oral administration
他の名前：
  • アウバジオ
  • HMR1726
薬：Placebo
Film-coated tablet Oral administration
実験的：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.
薬：Teriflunomide
Film-coated tablet Oral administration
他の名前：
  • アウバジオ
  • HMR1726
実験的：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.
薬：Teriflunomide
Film-coated tablet Oral administration
他の名前：
  • アウバジオ
  • HMR1726

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Core Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Core Treatment Period: Time to Conversion to Definite Multiple Sclerosis (DMS)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline, Week 108
Atrophy was measured by MRI scan.
Baseline, Week 108
Core Treatment Period: Time to 12-Week Sustained Disability Progression
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Sanofi

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2008年2月1日

一次修了 (実際)

2012年12月1日

研究の完了 (実際)

2016年2月1日

試験登録日

最初に提出

2008年2月14日

QC基準を満たした最初の提出物

2008年2月22日

最初の投稿 (見積もり)

2008年2月25日

学習記録の更新

投稿された最後の更新 (実際)

2017年3月13日

QC基準を満たした最後の更新が送信されました

2017年1月20日

最終確認日

2017年1月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • EFC6260
  • HMR1726D-3005 (その他の識別子：HMR)
  • 2006-001152-12 (EudraCT番号)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する