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A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in Subjects With Rheumatoid Arthritis

23. oktober 2015 oppdatert av: Vertex Pharmaceuticals Incorporated

A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs

This study is designed to evaluate the long-term safety and tolerability of VX-509 in subjects with active rheumatoid arthritis (RA) on DMARD therapy. This study will enroll subjects who completed a previous designated study with VX-509 (e.g., Study VX12-509-103).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This cascade ultimately contributes to abnormal immune response that results in chronic inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the treatment of RA.

This study will follow a "treat to target" (T2T) paradigm. T2T strategies have been followed in non-rheumatologic fields for decades. T2T trials have been conducted for RA from the late 1990's, and have substantiated the concept that treating to a target is associated with a better outcome than standard of care treatment. This has led to recommendations by experts to use T2T strategies in clinical practice.

Studietype

Intervensjonell

Registrering (Faktiske)

39

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Estland
      • Tallinn, Estland
        • Vertex Investigational Site
  • Forente stater
    • California
      • Upland, California, Forente stater
        • Vertex Investigational Site
    • Florida
      • Fort Lauderdale, Florida, Forente stater
        • Vertex Investigational Site
      • Venice, Florida, Forente stater
        • Vertex Investigational Site
      • West Palm Beach, Florida, Forente stater
        • Vertex Investigational Site
    • Georgia
      • Canton, Georgia, Forente stater
        • Vertex Investigational Site
      • Decatur, Georgia, Forente stater
        • Vertex Investigational Site
    • Kentucky
      • Elizabethtown, Kentucky, Forente stater
        • Vertex Investigational Site
    • Maryland
      • Fredrick, Maryland, Forente stater
        • Vertex Investigational Site
    • Nebraska
      • Lincoln, Nebraska, Forente stater
        • Vertex Investigational Site
    • New York
      • Rochester, New York, Forente stater
        • Vertex Investigational Site
    • North Carolina
      • Greensboro, North Carolina, Forente stater
        • Vertex Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Forente stater
        • Vertex Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forente stater
        • Vertex Investigational Site
    • Tennessee
      • Memphis, Tennessee, Forente stater
        • Vertex Investigational Site
    • Texas
      • Katy, Texas, Forente stater
        • Vertex Investigational Site
      • San Antonio, Texas, Forente stater
        • Vertex Investigational Site
      • Webster, Texas, Forente stater
        • Vertex Investigational Site
    • Washington
      • Spokane, Washington, Forente stater
        • Vertex Investigational Site
  • Litauen
      • Vilnius, Litauen
        • Vertex Investigational Site
  • Sør-Afrika
      • Pretoria, Sør-Afrika
        • Vertex Investigational Site
      • Stellenbosch, Sør-Afrika
        • Vertex Investigational Site

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 til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects must have completed the assigned study drug treatment phase of a previous VX-509 study (e.g., Study 103).
  • Subjects must voluntarily sign and date the Study 104 informed consent document.
  • Subject must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures.

Exclusion Criteria:

  • Inflammatory and rheumatological disorders other than RA, where arthritis may be a prominent feature.
  • History of any clinically significant illness that might, in the opinion of the investigator, confound the results of the study or pose an additional risk in administering study drug(s) to the subject
  • History of tuberculosis (TB), regardless of history of antimycobacterial treatment.
  • Planned surgery during the study.
  • History of alcohol or drug abuse, or excessive alcohol consumption as determined by the investigator, during the previous 12 months before Day 1.
  • Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Single Arm VX-509
Legemiddel: VX-509
VX-509 dose may be increased every 8 weeks in a stepwise fashion from 100 to 150 mg and from 150 to 200 mg, as needed (determined by ongoing disease activity by CDAI)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Long-term safety and tolerability of VX-509 treatment
Tidsramme: Baseline through 104 weeks
Measured by clinical laboratory tests
Baseline through 104 weeks
Long-term safety and tolerability of VX-509 treatment
Tidsramme: Baseline through 104 weeks
Measured by adverse events (AEs)
Baseline through 104 weeks
Long-term safety and tolerability of VX-509 treatment
Tidsramme: Baseline through 104 weeks
Measured by electrocardiograms (ECGs)
Baseline through 104 weeks
Long-term safety and tolerability of VX-509 treatment
Tidsramme: Baseline through 104 weeks
Measured by vital signs
Baseline through 104 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Proportion of subjects who achieve CDAI LDA (≤10) or CDAI remission (≤2.8)
Tidsramme: Baseline through 104 weeks
Baseline through 104 weeks
Proportion of subjects who achieve ≥20% (50%, 70%) improvement in disease severity according to the ACR criteria, using CRP (ACR20 CRP, ACR50 CRP, ACR70 CRP)
Tidsramme: Baseline through 104 weeks
Baseline through 104 weeks
Change from baseline in DAS28 using CRP (4-component) (DAS28 4[CRP])
Tidsramme: Baseline through 104 weeks
Baseline through 104 weeks
Proportion of subjects with DAS28 4(CRP) <2.6 (DAS remission)
Tidsramme: Baseline through 104 weeks
Baseline through 104 weeks
Proportion of subjects who achieve a moderate, good, or no response according to the EULAR response criteria from baseline
Tidsramme: Baseline through 104 weeks
Baseline through 104 weeks
Percentage of subjects with decreased dose of DMARD and/or corticosteroid (if receiving), including the subsets with 50% withdrawal and with full withdrawal (dose = 0)
Tidsramme: Baseline through 104 weeks
Baseline through 104 weeks
ACR hybrid scores
Tidsramme: Baseline through 104 weeks
Baseline through 104 weeks
Proportion of subjects who achieve ACR20/50/70 with erythrocyte sedimentation rate (ESR) and DAS28 4(ESR) response from baseline
Tidsramme: Baseline through 104 weeks
Baseline through 104 weeks
Proportion of subjects with DAS28 4(CRP) <3.2 (DAS LDA) from baseline
Tidsramme: Baseline through 104 weeks
Baseline through 104 weeks
Proportion of subjects achieving a clinical remission (2011 ACR/EULAR criteria), including subsets achieving either the low joint count or simplified disease activity index (SDAI) score remission options (or both) from baseline
Tidsramme: Baseline through week 104
Baseline through week 104
Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Tidsramme: Baseline through 104 weeks
Baseline through 104 weeks
Change from baseline in health-related quality of life assessed by 36-Item Short Form (SF 36) Physical Component Summary score and Physical Function (PF) subscale
Tidsramme: Baseline through 104 weeks
Baseline through 104 weeks

Andre resultatmål

Resultatmål
Tidsramme
Change in Outcome Measures in Rheumatology Clinical Trials (OMERACT) RAMRIS synovitis score, bone marrow edema (osteitis), erosion score, and joint space narrowing score by magnetic resonance imaging (MRI) in the designated hand
Tidsramme: Baseline through week 12
Baseline through week 12

Samarbeidspartnere og etterforskere

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

Sponsor

Vertex Pharmaceuticals Incorporated

Etterforskere

  • Studiestol: Bradley Bloom, MD, FACR, FAAP, Vertex Pharmaceuticals Incorporated

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. april 2013

Primær fullføring (Faktiske)

1. juli 2014

Studiet fullført (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først innsendt

10. april 2013

Først innsendt som oppfylte QC-kriteriene

10. april 2013

Først lagt ut (Anslag)

12. april 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. november 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. oktober 2015

Sist bekreftet

1. oktober 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • VX12-509-104
  • 2012-004342-14 (EudraCT-nummer)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på VX-509

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

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Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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