A PHASE 2, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MEDI-546 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

MedImmune, LLC, miembro del Grupo de Compañias de AstraZeneca,0 个研究点目标入组 50 人开始时间: 2012年6月14日最近更新: 2023年9月4日

试验速览

暂无简介。

•1) IN THE OPINION OF THE INVESTIGATOR, MUST HAVE ADEQUATE READING AND WRITING ABILITIES (IN THEIR NATIVE LANGUAGE) SUCH THAT THE SUBJECT CAN COMPREHEND AND COMPLETE THE INFORMED CONSENT, AND ALL PROTOCOL-RELATED SUBJECT ASSESSMENTS
•2) AGE 18-65 YEARS AT THE TIME OF SCREENING
•3) WRITTEN INFORMED CONSENT AND ANY LOCALLY REQUIRED AUTHORIZATION (EG, HIPAA IN THE USA, EU DATA PRIVACY DIRECTIVE IN THE EU) OBTAINED FROM THE SUBJECT PRIOR TO PERFORMING ANY PROTOCOL-RELATED PROCEDURES, INCLUDING SCREENING EVALUATIONS
•4) FULFILLS AT LEAST 4 OF THE 11 AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) CLASSIFICATION CRITERIA FOR SLE (SEE APPENDIX 2), ONE OF WHICH MUST BE:
•A. POSITIVE ANTINUCLEAR ANTIBODY (ANA) TEST ≥ 1:80 AT SCREENING BY IMMUNOFLUORESCENT ASSAY AT CENTRAL LABORATORY; OR
•B. ELEVATED ANTI-DSDNA OR ANTI-SM ANTIBODY AT SCREENING AS DETERMINED BY CENTRAL LABORATORY
•5) WEIGHT ≥ 40.0 KG AT SCREENING

•1) ANY CONDITION THAT, IN THE OPINION OF THE INVESTIGATOR, WOULD INTERFERE WITH EVALUATION OF THE INVESTIGATIONAL PRODUCT OR INTERPRETATION OF SUBJECT SAFETY OR STUDY RESULTS
•2) CONCURRENT ENROLLMENT IN ANOTHER CLINICAL STUDY WITH AN INVESTIGATIONAL PRODUCT WITHIN 4 WEEKS PRIOR TO DAY 1 OR WITHIN 5 HALF-LIVES OF THE INVESTIGATIONAL PRODUCT USED IN THAT CLINICAL STUDY, WHICHEVER IS LONGER
•3) EMPLOYEES OF THE CLINICAL STUDY SITE OR ANY OTHER INDIVIDUALS INVOLVED WITH THE CONDUCT OF THE STUDY, OR IMMEDIATE FAMILY MEMBERS OF SUCH INDIVIDUALS
•4) LACTATING OR PREGNANT FEMALES OR FEMALES WHO INTEND TO BECOME PREGNANT ANYTIME FROM INITIATION OF SCREENING THROUGH THE 85-DAY SAFETY FOLLOW-UP PERIOD FOLLOWING LAST DOSE OF INVESTIGATIONAL PRODUCT
•5) CURRENT SUGGESTION OF ALCOHOL, DRUG OR CHEMICAL ABUSE, OR A RECENT HISTORY OF SUCH ABUSE < 1 YEAR BEFORE RANDOMIZATION INTO THE STUDY
•6) MAJOR SURGERY WITHIN 8 WEEKS BEFORE SIGNING THE INFORMED CONSENT FORM OR ELECTIVE MAJOR SURGERY PLANNED DURING THE STUDY PERIOD (SEE APPENDIX 5 FOR GUIDANCE ON MAJOR SURGERY)

发起方

MedImmune, LLC, miembro del Grupo de Compañias de AstraZeneca,