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A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.

28. února 2018 aktualizováno: Hoffmann-La Roche

Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)

This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

201

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Ruská Federace
      • Chelyabinsk, Ruská Federace, 454076
        • Chelyabinsk Regional Clinical Hospital; Rheumatology
      • Cherkess, Ruská Federace, 369000
        • Republican clinical hospital of Karachai-Cherkess; Rheumatologic Department
      • Ekaterinburg, Ruská Federace, 620102
        • Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"
      • Ekaterinburg, Ruská Federace, 620102
        • Sverdlovsk Regional Clinical Hospital # 1; Rheumatology Dept
      • Irkutsk, Ruská Federace, 664047
        • Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise
      • Izhevsk, Ruská Federace, 426009
        • Republican Clinicodiagnostic Center
      • Kaliningrad, Ruská Federace, 236016
        • Kaliningrad Regional Clinical Hospital; Rheumatologic Department
      • Kemerovo, Ruská Federace, 650099
        • War Veterans Regional Clinical Hospital;Therapy Department
      • Kirov, Ruská Federace, 610028
        • Kirov Regional Clinical Hospital; Reumatology Department
      • Krasnodar, Ruská Federace, 350086
        • GUZ Regional clinical hospital # 1
      • Kursk, Ruská Federace, 305007
        • GMU Kursk regional clinical hospital
      • Moscow, Ruská Federace, 123060
        • Head Clinical Hospital of Internal Affair Ministry of Russia
      • Moscow, Ruská Federace, 129110
        • Vladimirskiy Regional Scientific Research Inst.
      • Moscow, Ruská Federace, 115522
        • FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences
      • Moscow, Ruská Federace, 115682
        • FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"
      • Moscow, Ruská Federace, 121359
        • FGU Central Clinical Hospital with Polyclinic Administration President RF
      • Nizhny Novgorod, Ruská Federace, 603126
        • SIH Nizhny Novgorod Regional Clinical Hospital n.a. Semashko
      • Petrozavodsk, Ruská Federace, 185019
        • Republican Hospital Named After V.A. Baranov
      • Rostov-na-Donu, Ruská Federace, 344022
        • Rostov State Medical University; Cardiorheumatology Department
      • Smolensk, Ruská Federace, 214001
        • Clinical hospital #1
      • Surgut, Ruská Federace, 628408
        • Surgut Region Clinical Hospital
      • Tjumen, Ruská Federace, 625023
        • Glpu Tjumen Regional Clinical Hospital #1
      • UFA, Ruská Federace, 450005
        • Republican clinical hospital named after G.G. Kuvatov
      • Ulyanovsk, Ruská Federace, 432063
        • State Institution of Healthcare Ulyanovsk Regional Clinical Hospital
      • Veliky Novgorod, Ruská Federace, 173008
        • GUZ "Novgorod Regional Clinical Hospital"; Cardioreumatological
      • Voronezh, Ruská Federace, 394066
        • Voronezh Regional Clinical Hospital #1
      • Voronezh, Ruská Federace, 394066
        • Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
      • Yaroslavl, Ruská Federace, 150062
        • SHI Yaroslavl Regional Clinical Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • moderate to severe active rheumatoid arthritis of >/=6 months duration
  • inadequate clinical response to current non-biologic DMARDs
  • current DMARDs must be at stable dose for 8 weeks prior to study entry
  • oral corticosteroids (</=10mg/day prednisone or equivalent) and NSAIDs must be at stable dose for >/=4 weeks prior to screening

Exclusion Criteria:

  • rheumatic autoimmune disease other than RA
  • history of or current inflammatory joint disease other than RA
  • previous treatment with any biologic DMARD
  • functional class IV as defined by the ACR classification
  • intra-articular or parenteral corticosteroids within 6 weeks prior to screening

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 1
Lék: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks for 24 weeks
Lék: DMARDs (disease-modifying antirheumatic drugs)
stable doses at investigator's prescription

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Health Assessment Questionnaire (HAQ) Score
Časové okno: Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Withdrawal Visit is the final visit prior to the withdrawal of the subject from the study.
Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit
Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment
Časové okno: Weeks 4, 8, 12, 16, 20, and 24
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
Weeks 4, 8, 12, 16, 20, and 24
Change in HAQ Score at Week 24
Časové okno: Baseline and Week 24
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
Baseline and Week 24

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Pain Score as Assessed by Visual Analogue Scale (VAS)
Časové okno: Weeks 0, 4, 8, 12, 16, 20, and 24
Participant's global assessment of pain was assessed using a 100-millimeter (mm) horizontal VAS (0 to 100 mm) with 0=pain absent and 100=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain.
Weeks 0, 4, 8, 12, 16, 20, and 24
European Quality of Life - 5 Dimensions (EQ-5D) Score
Časové okno: Weeks 0, 4, 8, 12, 16, 20, and 24
EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Weeks 0, 4, 8, 12, 16, 20, and 24
Change in EQ-5D Score at Week 24 From Baseline
Časové okno: Baseline and Week 24
EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Minimum clinically significant change in EQ-5D corresponds to the parameter differences before and after treatment = 0.10. Graduations of assessment of the therapy efficacy by EQ-5D are: Difference (Δ) EQ-5D less than (<)0.10 points: none; 0.10 less than or equal to (≤)Δ EQ-5D ≤0.24: minimal effect; 0.24≤ Δ EQ-5D <0.31: satisfactory effect; Δ EQ-5D greater than or equal to (≥)0.31 points: pronounced effect.
Baseline and Week 24
General Health Score as Assessed by EQ-5D VAS
Časové okno: Weeks 0, 4, 8, 12, 16, 20, and 24
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.
Weeks 0, 4, 8, 12, 16, 20, and 24
Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D
Časové okno: Weeks 0, 4, 8, 12, 16, 20, and 24
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. Positive response was defined as an increase of EQ-5D score by 0.1 or more i.e. it is a clinically significant increase.
Weeks 0, 4, 8, 12, 16, 20, and 24
Change in General Health Assessed by VAS
Časové okno: Baseline and Week 24
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.
Baseline and Week 24
Disease Activity Score Based on 28-Joint Count (DAS28)
Časové okno: Weeks 0, 4, 8, 12, 16, 20, and 24
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
Weeks 0, 4, 8, 12, 16, 20, and 24
Change in DAS28 Score From Baseline to Week 24
Časové okno: Baseline and Week 24
Baseline and Week 24
Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment
Časové okno: Weeks 0, 4, 8, 12, 16, 20, and 24
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR mm/hour, and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Disease activity: 0=remission (DAS28 less than [<] 2.6), I=low (DAS28 less than or equal to [≤]2.6 to <3.2), II=moderate (DAS28=3.2 to 5.1), III=high (DAS28 greater than [>]5.1).
Weeks 0, 4, 8, 12, 16, 20, and 24
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response
Časové okno: Weeks 0, 4, 8, 12, 16, 20, and 24
ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) and in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase response: C-reactive protein (CRP) or ESR.
Weeks 0, 4, 8, 12, 16, 20, and 24
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
Časové okno: Weeks 4, 8, 12, 16, 20, and 24
The DAS28-based EULAR response criteria were used to measure individual response as no effect, good effect, and moderate effect, depending on the extent of change from baseline and the level of disease activity reached. Good effect: change from baseline >1.2 with DAS28 score ≤3.2; moderate effect: change from baseline >1.2 with DAS28 score 3.2 to 5.1 or change from baseline >0.6 to <1.2 with DAS28 score <3.2; no effect: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 score >5.1.
Weeks 4, 8, 12, 16, 20, and 24
C-Reactive Protein
Časové okno: Weeks 4, 8, 12, 16, 20, and 24
CRP (milligrams/Liter) is a mediator of inflammation, acute phase protein.
Weeks 4, 8, 12, 16, 20, and 24
Erythrocyte Sedimentation Rate
Časové okno: Weeks 4, 8, 12, 16, 20, and 24
ESR (mm/hr) is used to determine the acute phase response.
Weeks 4, 8, 12, 16, 20, and 24

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hoffmann-La Roche

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

31. října 2009

Primární dokončení (Aktuální)

14. února 2011

Dokončení studie (Aktuální)

14. února 2011

Termíny zápisu do studia

První předloženo

15. října 2009

První předloženo, které splnilo kritéria kontroly kvality

15. října 2009

První zveřejněno (Odhad)

16. října 2009

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. března 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. února 2018

Naposledy ověřeno

1. února 2018

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

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