Brentuximab Vedotin in Early Diffuse Cutaneous Systemic Sclerosis

Exclusion Criteria

• •1. Poor pulmonary function (FVC\<40% and/or DLCO\<30%).
• •2. Pregnancy, breast feeding or child bearing potential without practicing reliable contraception (and partners for men in the study).
• •3. Clinically significant pulmonary hypertension requiring drug therapy.
• •4. Clinically significant cardiac disease.
• •5. Chronic or ongoing active infectious disease requiring systemic treatment.
• •6. Seropositivity for human immunodeficiency virus (HIV) at study entry.
• •7. Active tuberculosis (TB) infection.
• •8. Active viral infection with viral replication of hepatitis B or C virus at study entry.
• •9. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, pancreatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease; and cancer.
• •10. Peripheral neuropathy at screening Grade 2 or higher.
• •11. Known or suspected hypersensitivity to components of the treatment
• •12. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
• •13. Any of the following laboratory abnormalities at screening:
• •* Absolute neutrophils count \<2000/mm3
• •* Hemoglobin \<85 g/L
• •* Platelet count \< 100,000/mm3
• •* AST/SGOT or ALT/SGPT \>2.0 UNL
• •14. Participation in another clinical trial within six weeks before randomization in this study
• •15. Use of rituximab within the previous 4 months.
• •16. Immunization with a live/ attenuated vaccine less than 4 weeks prior to the baseline visit.
• •17. Previous use of brentuximab vedotin.
• •18. Current or history of progressive multifocal leukoencephalopathy (PML).