Clinical Trials Detalhe
A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
General Information
Gender
ALL
Age
from 18 Years to 75 Years
Phase
PHASE2
Study Type
INTERVENTIONAL
Location
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/NCT03845517Summary
Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.
Conditions
Systemic Lupus Erythematosus
Eligibility
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.