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 bijgewerkt door: 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).
Studie Overzicht
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
39
Fase
- Fase 2
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Tallinn, Estland
- Vertex Investigational Site
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Vilnius, Litouwen
- Vertex Investigational Site
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California
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Upland, California, Verenigde Staten
- Vertex Investigational Site
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Florida
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Fort Lauderdale, Florida, Verenigde Staten
- Vertex Investigational Site
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Venice, Florida, Verenigde Staten
- Vertex Investigational Site
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West Palm Beach, Florida, Verenigde Staten
- Vertex Investigational Site
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Georgia
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Canton, Georgia, Verenigde Staten
- Vertex Investigational Site
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Decatur, Georgia, Verenigde Staten
- Vertex Investigational Site
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Kentucky
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Elizabethtown, Kentucky, Verenigde Staten
- Vertex Investigational Site
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Maryland
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Fredrick, Maryland, Verenigde Staten
- Vertex Investigational Site
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Nebraska
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Lincoln, Nebraska, Verenigde Staten
- Vertex Investigational Site
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New York
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Rochester, New York, Verenigde Staten
- Vertex Investigational Site
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North Carolina
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Greensboro, North Carolina, Verenigde Staten
- Vertex Investigational Site
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Pennsylvania
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Duncansville, Pennsylvania, Verenigde Staten
- Vertex Investigational Site
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South Carolina
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Charleston, South Carolina, Verenigde Staten
- Vertex Investigational Site
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Tennessee
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Memphis, Tennessee, Verenigde Staten
- Vertex Investigational Site
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Texas
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Katy, Texas, Verenigde Staten
- Vertex Investigational Site
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San Antonio, Texas, Verenigde Staten
- Vertex Investigational Site
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Webster, Texas, Verenigde Staten
- Vertex Investigational Site
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Washington
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Spokane, Washington, Verenigde Staten
- Vertex Investigational Site
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Pretoria, Zuid-Afrika
- Vertex Investigational Site
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Stellenbosch, Zuid-Afrika
- Vertex Investigational Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Single Arm VX-509
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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)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Long-term safety and tolerability of VX-509 treatment
Tijdsspanne: Baseline through 104 weeks
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Measured by clinical laboratory tests
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Baseline through 104 weeks
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Long-term safety and tolerability of VX-509 treatment
Tijdsspanne: Baseline through 104 weeks
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Measured by adverse events (AEs)
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Baseline through 104 weeks
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Long-term safety and tolerability of VX-509 treatment
Tijdsspanne: Baseline through 104 weeks
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Measured by electrocardiograms (ECGs)
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Baseline through 104 weeks
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Long-term safety and tolerability of VX-509 treatment
Tijdsspanne: Baseline through 104 weeks
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Measured by vital signs
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Baseline through 104 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Proportion of subjects who achieve CDAI LDA (≤10) or CDAI remission (≤2.8)
Tijdsspanne: Baseline through 104 weeks
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Baseline through 104 weeks
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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)
Tijdsspanne: Baseline through 104 weeks
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Baseline through 104 weeks
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Change from baseline in DAS28 using CRP (4-component) (DAS28 4[CRP])
Tijdsspanne: Baseline through 104 weeks
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Baseline through 104 weeks
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Proportion of subjects with DAS28 4(CRP) <2.6 (DAS remission)
Tijdsspanne: Baseline through 104 weeks
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Baseline through 104 weeks
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Proportion of subjects who achieve a moderate, good, or no response according to the EULAR response criteria from baseline
Tijdsspanne: Baseline through 104 weeks
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Baseline through 104 weeks
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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)
Tijdsspanne: Baseline through 104 weeks
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Baseline through 104 weeks
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ACR hybrid scores
Tijdsspanne: Baseline through 104 weeks
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Baseline through 104 weeks
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Proportion of subjects who achieve ACR20/50/70 with erythrocyte sedimentation rate (ESR) and DAS28 4(ESR) response from baseline
Tijdsspanne: Baseline through 104 weeks
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Baseline through 104 weeks
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Proportion of subjects with DAS28 4(CRP) <3.2 (DAS LDA) from baseline
Tijdsspanne: Baseline through 104 weeks
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Baseline through 104 weeks
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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
Tijdsspanne: Baseline through week 104
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Baseline through week 104
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Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Tijdsspanne: Baseline through 104 weeks
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Baseline through 104 weeks
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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
Tijdsspanne: Baseline through 104 weeks
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Baseline through 104 weeks
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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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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
Tijdsspanne: Baseline through week 12
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Baseline through week 12
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie stoel: Bradley Bloom, MD, FACR, FAAP, Vertex Pharmaceuticals Incorporated
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2013
Primaire voltooiing (Werkelijk)
1 juli 2014
Studie voltooiing (Werkelijk)
1 juli 2014
Studieregistratiedata
Eerst ingediend
10 april 2013
Eerst ingediend dat voldeed aan de QC-criteria
10 april 2013
Eerst geplaatst (Schatting)
12 april 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
20 november 2015
Laatste update ingediend die voldeed aan QC-criteria
23 oktober 2015
Laatst geverifieerd
1 oktober 2015
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- VX12-509-104
- 2012-004342-14 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .