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Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients

12. desember 2012 oppdatert av: Chugai Pharma Taiwan

Randomized, Placebo-controlled Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients

This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with Rheumatoid Arthritis.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

86

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Taiwan
      • Chiayi, Taiwan
        • Buddhist Dalin Tzu Chi General Hospital
      • Kaohsiung, Taiwan
        • Kaohsiung Medical University Hospital
      • Kaohsiung, Taiwan
        • Kaohsiung Veterans General Hospital
      • Kaohsiung, Taiwan
        • Chang Gung Memorial Hospital -Kaohsiung
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Taichung, Taiwan
        • Chung Shan Medical University Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • Tri-Service General Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Taipei, Taiwan
        • Cathay General Hospital
      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital - Linkou

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

20 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients diagnosed with history of moderate-to- severe rheumatoid arthritis for more than 6 months according to the American College of Rheumatology (ACR) 1987 revised criteria for the classification of RA.
  • Patients who failed to achieve clinical response to treatment of at least 2 DMARDs(disease modifying anti-rheumatic drug) (including MTX) for at least 12 weeks within 12 months prior to screening, of which MTX must have been at a stable dose of 10-20 mg/wk for at least 12 weeks prior to screening. All other DMARDs should be given at standard therapeutic dose.
  • Patients who satisfy swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
  • C-reactive protein (CRP) level ≥ 1 mg/dl or an erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour at screening and at baseline.

Exclusion Criteria:

  • Patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment.
  • Patients with rheumatoid autoimmune disease other than RA, including but not limited to SLE(system lupus erythematosus), or significant systemic involvement secondary to RA.
  • Patients who belong to the Class IV of the ACR classification criteria for functional status of RA. (ACR Amended Criteria for the Classification of Functional Capacity in Rheumatoid Arthritis; Class IV: Largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care).
  • Patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them.
  • Patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(TB),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis B, hepatitis C, or herpes zoster and etc. However, a patient with hand & foot fungal infections can participate.

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
Legemiddel: Tocilizumab + methotrexate(MTX)
Tocilizumab:8 mg/kg every4weeks,IV infusion methotrexate:10-20 mg/week
Placebo komparator: 2
Legemiddel: Tocilizumab placebo + methotrexate(MTX)
Tocilizumab placebo:8 mg/kg every 4 weeks,IV infusion methotrexate:10-20 mg/week

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of patients with an American College of Rheumatology 20(ACR20) response
Tidsramme: at baseline and week 24
at baseline and week 24

Sekundære resultatmål

Resultatmål
Tidsramme
Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively
Tidsramme: at baseline and week 24
at baseline and week 24
Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28)
Tidsramme: at baseline and week 24
at baseline and week 24
Proportion of patients achieving DAS28 remission (DAS28 < 2.6)
Tidsramme: at week 24
at week 24
Adverse event incidence
Tidsramme: from baseline to week 24
from baseline to week 24
Mean change from baseline to evaluation visits in vital signs
Tidsramme: from baseline to week 24
from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results.
Tidsramme: from baseline to week 24
from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative urinalysis results.
Tidsramme: from baseline to week 24
from baseline to week 24
Proportion of patients with ACR50 response
Tidsramme: at baseline and week 24
at baseline and week 24
Proportion of patients with ACR70 response
Tidsramme: at baseline and week 24
at baseline and week 24
Result of Electrocardiogram. From baseline to evaluation visits
Tidsramme: from baseline to week 24
from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative hematological exam results (including Hb, Ht, RBC, WBC & differential, platelet counts).
Tidsramme: from baseline to week 24
from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results (including AST, ALT, Alk-p, γ-GTP, LDH, total protein, albumin, total bilirubin, BUN, uric acid, creatinine, glucose, ferritin, K, Na, Cl, Ca, P.).
Tidsramme: from baseline to week 24
from baseline to week 24

Samarbeidspartnere og etterforskere

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

Sponsor

Chugai Pharma Taiwan

Etterforskere

  • Studiestol: Yoshiaki Someya, Chugai Pharma Taiwan

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

1. desember 2010

Primær fullføring (Faktiske)

1. oktober 2012

Studiet fullført (Faktiske)

1. oktober 2012

Datoer for studieregistrering

Først innsendt

8. desember 2010

Først innsendt som oppfylte QC-kriteriene

10. desember 2010

Først lagt ut (Anslag)

13. desember 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

13. desember 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. desember 2012

Sist bekreftet

1. desember 2012

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MRA230TW

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