Testing Brentuximab vedotin for diffuse cutaneous systemic sclerosis

Exclusion

• −Known or suspected hypersensitivity to components of the treatment
• −Seropositivity for human immunodeficiency virus (HIV).
• −Active viral infection with viral replication of hepatitis B or C virus.
• −Poor pulmonary function (FVC\<40% and/or DLCO\<30%).
• −Clinically significant pulmonary hypertension requiring drug therapy.
• −Clinically significant cardiac disease.
• −Chronic or ongoing active infectious disease requiring systemic treatment.
• −Active tuberculosis (TB) infection.
• −Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, pancreatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease; and cancer.
• −Peripheral neuropathy at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → Grade 2 or higher.
• −Patients known or suspected of not being able to comply with a study protocolProtocolThe detailed plan a study must follow.Read more → (e.g. due to alcoholism, drug dependency or psychological disorder)
• −Any of the following laboratory abnormalities at screening:
• −Absolute neutrophils count \<2.0 x 109/L
• −Hemoglobin \<85 g/L
• −Platelet count \< 100 x 109/L
• −AST/SGOT or ALT/SGPT \>2.0 UNL
• −Participation in another clinical trialInterventional studyA study where participants are given something to see what happens.Read more → within six weeks before randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → in this study, with the exception of continuation from the initial study BV201708.
• −Use of rituximab within the previous 4 months.
• −Immunization with a live/ attenuated vaccine less than 4 weeks prior to the baseline visitBaselineYour starting measurements, taken before treatment begins.Read more →.
• −Current or history of progressive multifocal leukoencephalopathy (PML).
• −Pregnancy, breast feeding or child bearing potential without practicing highly effective contraception (and partners for men in the study).