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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. februar 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

201

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
Legemiddel: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks for 24 weeks
Legemiddel: DMARDs (disease-modifying antirheumatic drugs)
stable doses at investigator's prescription

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Health Assessment Questionnaire (HAQ) Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain Score as Assessed by Visual Analogue Scale (VAS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline and Week 24
Baseline and Week 24
Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hoffmann-La Roche

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

31. oktober 2009

Primær fullføring (Faktiske)

14. februar 2011

Studiet fullført (Faktiske)

14. februar 2011

Datoer for studieregistrering

Først innsendt

15. oktober 2009

Først innsendt som oppfylte QC-kriteriene

15. oktober 2009

Først lagt ut (Anslag)

16. oktober 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mars 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. februar 2018

Sist bekreftet

1. februar 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ML22665

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