PER-021-12
Unknown
未知
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 sites50 target enrollmentJune 14, 2012
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MedImmune, LLC, miembro del Grupo de Compañias de AstraZeneca,
- Enrollment
- 50
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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