PER-031-12未知未知
A PHASE II RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO STUDY THE SAFETY AND IMMUNOGENICITY OF V212 IN ADULT PATIENTS WITH AUTOIMMUNE DISEASE
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 20 人开始时间: 2012年7月19日最近更新:
试验速览
- 阶段
- 未知
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 120（—）
- 性别
- All
入选标准
- •1. PATIENT IS ≥ 18 YEARS OF AGE ON THE DAY OF SIGNING INFORMED CONSENT.
- •2. PATIENT HAS BEEN DIAGNOSED WITH AN AUTOIMMUNE DISEASE, INCLUDING BUT NOT LIMITED TO RA, PSA, PSO, IBD, SLE, MS, OR OTHER SIMILAR DISEASES (SEE APPENDIX 6.1). (NOTE: SLE PATIENT MUST FULFILL THE REVISED AMERICAN COLLEGE OF RHEUMATOLOGY CLASSIFICATION CRITERIA FOR DIAGNOSIS [SLE DIAGNOSIS CRITERIA PROVIDED IN APPENDIX 6.3]. MS PATIENT MUST FULFILL THE 2010 REVISIONS TO THE MCDONALD CRITERIA FOR DIAGNOSIS OF MS [MS DIAGNOSIS CRITERIA PROVIDED IN APPENDIX 6.4]).
- •3. PATIENT IS NOT LIKELY TO UNDERGO HET DURING THE STUDY PERIOD (THROUGH 28 DAYS POSTDOSE 4).
- •4. PATIENT MUST BE ON AT LEAST ONE BIOLOGIC AGENT, SUCH AS A TNF ALPHA INHIBITOR, OR A NON-BIOLOGIC THERAPY, AT A STABLE DOSE FOR ≥ 3 MONTHS, WITH NO PLANNED OR ANTICIPATED CHANGES IN TREATMENT REGIMEN AT THE TIME OF ENROLLMENT. TREATMENT ROUTE OF ADMINISTRATION MUST BE PARENTERAL OR ORAL; TOPICAL ADMINISTRATION ALONE IS NOT SUFFICIENT (SEE APPENDIX 6.2).
- •5. MINIMUM DOSES ARE REQUIRED FOR THE FOLLOWING TREATMENTS IF TAKEN AS MONOTHERAPY:
排除标准
- •1. A HISTORY OF ALLERGIC REACTION TO ANY VACCINE COMPONENT (INELUDING GELATIN) OR AN ANAPHYLACTIC/ANAPHYLACTOID REACTION TO NEOMYCIN (A HISTORY OF CONTACT DERMATITIS TO NEOMYCIN IS NOT A CRITERION FOR STUDY EXCLUSION).
- •2. PRIOR HISTORY OF HZ WITHIN 1 YEAR OF ENROLLMENT.
- •3. PRIOR RECEIPT OF ANY VARICELLA OR ZOSTER VACCINE.
- •4. PATIENT HAS ACTIVE CENTRAL NERVOUS SYSTEM (CNS) LUPUS (INCLUDING SEIZURES, PSYCHOSIS, ORGANIC BRAIN SYNDROME, CEREBRITIS OR CNS VASCULITIS) REQUIRING THERAPEUTIC INTERVENTION WITHIN 90 DAYS OF ENROLLMENT.
- •5. PATIENT IS RECEIVING OR EXPECTED TO RECEIVE THERAPY CONTAINING RITUXIMAB OR ANY OTHER ANTI-CD20 MONOCLONAL ANTIBODIES AT ANY TIME DURING THE TIME PERIOD BEGINNING 3 MONTHS PRIOR TO ENROLLMENT THROUGH 28 DAYS POSTDOSE 4.
- •6. PATIENT IS RECEIVING SYSTEMIC CORTICOSTEROID THERAPY, PREDNISONE OR PREDNISONE EQUIVALENT > 40 MG/DAY AT THE TIME OF ENROLLMENT.
- •7. PATIENT HAS RECEIVED SYSTEMIC PREDNISONE OR PREDNISONE EQUIVALENT ≥ 50 MG/DAY FOR ≥ 30 DAYS WITHIN 6 MONTHS OF ENROLLMENT.
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