A PHASE 3, MULTI-CENTER, MULTINATIONAL, RANDOMIZED, DOUBLE-BLIND, STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BELIMUMAB (HGS1006) IN COMBINATION WITH AZATHIOPRINE FOR THE MAINTENANCE OF REMISSION IN WEGENER’S GRANULOMATOSIS AND MICROSCOPICPOLYANGIITIS

HUMAN GENOME SCIENCES, INC.,0 个研究点目标入组 10 人开始时间: 2014年4月30日最近更新: 2023年9月4日

适应症

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•1. Are at least 18 years of age. 2. Have a clinical diagnosis of Wegener’s granulomatosis (WG) or a diagnosis ofmicroscopic polyangiitis (MPA) according to the Chapel Hill criteria 3. In the 26 weeks prior to randomization (Day 0), had an episode of moderately to severely active WG or MPA requiring treatment 4. Have documented evidence of either anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) prior to Day 0. 5. Have a Birmingham Vasculitis Activity Score (BVAS v.3 [Appendix 3]) of 0 and bereceiving < 10 mg/day oral prednisone (or equivalent) 6. Subjects receiving non-systemic corticosteroids for reasons other than vasculitis must beon a stable regimen prior to randomization. 7. A female subject is eligible to enter the study if she is: - Not pregnant or nursing;- Of non-childbearing potential or - Of childbearing potential These women must have a negativeserum pregnancy test at screening, 8. Have the ability to understand the requirements of the study and provide written informedconsent and comply with the study protocol procedures (including required study visits).

•Co-existence of other multisystem autoimmune diseases. 2. Known intolerance to azathioprine3. Have received treatment with a B-cell directed therapy4. Have required 3 or more courses of systemic corticosteroids 5. Have received a non-biologic or biologic investigational agent 6. Have received a live vaccine7. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases 8. Have a planned surgical procedure or a history of any other medical disease 9. Have a history of malignant neoplasm within the last 5 years, 10. Have required management of acute or chronic infections, 11. Have current drug or alcohol abuse or dependence12. Have a historically positive HIV test or test positive at screening for HIV. 13. Hepatitis B: Serologic evidence of Hepatitis B 14. Hepatitis C15. Have an IgA deficiency 16. Have a Grade 3 or greater laboratory abnormality based on the protocol DMID 17. Have a history of an anaphylactic reaction 18. Subjects who have evidence of serious suicide risk including any history of suicidal behavior 19. Subjects who have abnormal liver function

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