Clinical Trials Detalhe
A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Visão Geral
Gender
ALL
Idade
from 18 Years to 75 Years
Fase
PHASE2
Tipo de Estudo
INTERVENTIONAL
Localização
Hospital Garcia de Orta, E.P.E (Almada, Portugal)
Hospital Professor Doutor Fernando da Fonseca, E.P.E (Amadora, Portugal)
Unidade Local de Saude do Alto Minho, E.P.E. (Ponte de Lima, Portugal)
Centro Hospitalar Universitario do Porto, E.P.E (Porto, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT03845517Sumário
Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.
Condições
Systemic Lupus Erythematosus
Elegibilidade
Inclusion Criteria: * Male and/or female subjects between ≥18 and ≤75 years of age inclusive. * Diagnosis of moderate to severe active Lupus. * Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids. Exclusion Criteria: * Active renal lupus * Severe active central nervous system (CNS) lupus * Have cancer or a history of cancer within 5 years of screening. * Have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus. * Active bacterial, viral, fungal, mycobacterial or other infections * Psychiatric condition including recent or active suicidal ideation or behavior * Have active fibromyalgia/myofascial/chronic pain. * Pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and WOCBP who are unwilling or unable to use a highly effective method of contraception.