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

2017. január 20. frissítette: 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

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

618

Fázis

  • 3. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

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

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Kettős

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Placebo Comparator: 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.
Drog: Teriflunomide
Film-coated tablet Oral administration
Más nevek:
  • Aubagio
  • HMR1726
Drog: Placebo
Film-coated tablet Oral administration
Kísérleti: 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.
Drog: Teriflunomide
Film-coated tablet Oral administration
Más nevek:
  • Aubagio
  • HMR1726
Kísérleti: 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.
Drog: Teriflunomide
Film-coated tablet Oral administration
Más nevek:
  • Aubagio
  • HMR1726

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Core Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS)
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Core Treatment Period: Time to Conversion to Definite Multiple Sclerosis (DMS)
Időkeret: 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)
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: Baseline, Week 108
Atrophy was measured by MRI scan.
Baseline, Week 108
Core Treatment Period: Time to 12-Week Sustained Disability Progression
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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

Egyéb eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Sanofi

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2008. február 1.

Elsődleges befejezés (Tényleges)

2012. december 1.

A tanulmány befejezése (Tényleges)

2016. február 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2008. február 14.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2008. február 22.

Első közzététel (Becslés)

2008. február 25.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2017. március 13.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2017. január 20.

Utolsó ellenőrzés

2017. január 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • EFC6260
  • HMR1726D-3005 (Egyéb azonosító: HMR)
  • 2006-001152-12 (EudraCT szám)

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Klinikai vizsgálatok a Sclerosis multiplex

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Kábítószer-beavatkozások

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