A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy With 104-Week Open Label Extension

CompletadoFase 2ClinicalTrials.gov

ID: NCT01590459RENIS: IS000223Tipo: INTERVENTIONALInicio: 1 de abr de 2012Fin estimado: 1 de jul de 2014

Traducción no disponible, mostrando original

Resumen

This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3 inhibitor, for treatment of subjects with active RA who have had an inadequate response to Methotrexate.

Descripción detallada

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, and a broad range of other autoimmune diseases.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Male and female subjects, between 18 and 80 years of age (inclusive)
All subjects must have been diagnosed with RA
Must have a swollen joint count of ≥6 out of 66 joints and tender joint count of ≥6 out of 68 joints
Baseline CRP level must be above the upper limit of normal
All subjects must have been receiving stable MTX coadministered with folic or folinic acid (at least 5 mg/week)
Subjects may remain on 1 nonsteroidal anti-inflammatory medication during the study (aspirin ≤ 325 mg/day is allowed).
Subjects must not have received prior treatment with a JAK inhibitor
Subjects who are on an additional nonbiologic DMARD (e.g., sulfasalazine) must be willing to discontinue that DMARD after signing consent, except for hydroxychloroquine
Subjects may have received previous therapy with a single TNF inhibitor (e.g., etanercept, adalimumab, infliximab, golimumab, certolizumab pegol)
Females must have a negative pregnancy test prior to study dosing
Sexually active subjects and their partners must agree to contraceptive requirements

Criterios de exclusión

History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Subjects with inflammatory, rheumatological disorders other than RA
Pregnant or nursing female subjects
Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant
Subjects who have planned major surgery (e.g., joint replacement) or procedures during the study
History of drug abuse or positive drug screen
History of alcohol abuse or excessive alcohol consumption
History of tuberculosis (TB) infection of any kind (pulmonary or extrapulmonary, active or latent), regardless of history of anti-TB treatment.

Intervenciones

drug

VX-509

50 mg oral tablet

drug

VX-509 matching placebo

0 mg oral tablet

Ubicaciones

Vertex Investigational Site

Buenos Aires, Argentina

Vertex Investigational Site

Buenos Aires, Argentina

Vertex Investigational Site

Buenos Aires, Argentina

Vertex Investigational Site

Santa Fe, Argentina

Patrocinadores

PrincipalVertex Pharmaceuticals Incorporated

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