Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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 uppdaterad 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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

39

Fas

  • Fas 2
  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Single Arm VX-509
Läkemedel: 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)

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Tidsram
Proportion of subjects who achieve CDAI LDA (≤10) or CDAI remission (≤2.8)
Tidsram: 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)
Tidsram: Baseline through 104 weeks
Baseline through 104 weeks
Change from baseline in DAS28 using CRP (4-component) (DAS28 4[CRP])
Tidsram: Baseline through 104 weeks
Baseline through 104 weeks
Proportion of subjects with DAS28 4(CRP) <2.6 (DAS remission)
Tidsram: 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
Tidsram: 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)
Tidsram: Baseline through 104 weeks
Baseline through 104 weeks
ACR hybrid scores
Tidsram: 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
Tidsram: Baseline through 104 weeks
Baseline through 104 weeks
Proportion of subjects with DAS28 4(CRP) <3.2 (DAS LDA) from baseline
Tidsram: 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
Tidsram: Baseline through week 104
Baseline through week 104
Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Tidsram: 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
Tidsram: Baseline through 104 weeks
Baseline through 104 weeks

Andra resultatmått

Resultatmått
Tidsram
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
Tidsram: Baseline through week 12
Baseline through week 12

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Vertex Pharmaceuticals Incorporated

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2013

Primärt slutförande (Faktisk)

1 juli 2014

Avslutad studie (Faktisk)

1 juli 2014

Studieregistreringsdatum

Först inskickad

10 april 2013

Först inskickad som uppfyllde QC-kriterierna

10 april 2013

Första postat (Uppskatta)

12 april 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

20 november 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 oktober 2015

Senast verifierad

1 oktober 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera