Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

39

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Single Arm VX-509
Medicin: 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vertex Pharmaceuticals Incorporated

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2013

Primær færdiggørelse (Faktiske)

1. juli 2014

Studieafslutning (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først indsendt

10. april 2013

Først indsendt, der opfyldte QC-kriterier

10. april 2013

Først opslået (Skøn)

12. april 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rheumatoid arthritis

Kliniske forsøg med VX-509

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Spain

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner