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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 febbraio 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

201

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 1
Droga: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks for 24 weeks
Droga: DMARDs (disease-modifying antirheumatic drugs)
stable doses at investigator's prescription

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Health Assessment Questionnaire (HAQ) Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Score as Assessed by Visual Analogue Scale (VAS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Baseline and Week 24
Baseline and Week 24
Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

31 ottobre 2009

Completamento primario (Effettivo)

14 febbraio 2011

Completamento dello studio (Effettivo)

14 febbraio 2011

Date di iscrizione allo studio

Primo inviato

15 ottobre 2009

Primo inviato che soddisfa i criteri di controllo qualità

15 ottobre 2009

Primo Inserito (Stima)

16 ottobre 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 marzo 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 febbraio 2018

Ultimo verificato

1 febbraio 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ML22665

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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