A DOUBLE-BLIND, RANDPMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
- Registration Number
- PER-017-12
- Lead Sponsor
- Pfizer Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 4
1. EVIDENCE OF A PERSONALLY SIGNED AND DATED INFORMED CONSENT FORM DOCUMENT INDICATING THAT THE SUBJECT (OR LEGALLY ACCEPTABLE REPRESENTATIVE) HAS BEEN INFORMED OF ALL PERTINENT ASPECTS OF THE STUUDY.
2. SUBJECTS WHO ARE WILLING AND ABLE TO COMPLY WITH SCHEDULED VISITS, TREATMENT PLAN, LABORATORY TESTS, AND OTHER STUDY PROCEDURES.
3. MALE AND/OR FEMALE SUBJECTS BETWEEN THE AGES OF ≥ 18 AND ≤ 75 YEARS OLD AT THE TIME OF SIGNING OF INFORMED CONSENT FORM (ICF).
4. HAVE A CLINICAL DIAGNOSIS OF SLE ACCORDING TO THE 1997 UPDATE ON THE 1982 REVISED AMERICAN COLLEGE RHEUMATOLOGY (ACR) CRITERIA (SEE APPENDIX 6).
5. HAVE UNEQUIVOCALLY POSITIVE ANTI-NUCLEAR ANTIBODY (ANA) TEST RESULTS BY EITHER:
. POSITIVE TEST RESULT FROM WITHIN THE STUDY SCREENING PERIOD. SCREENING RESULTS MUST BE BASED ON THE STUDY´S CENTRAL LABORATORY RESULTS. A POSITIVE ANA TEST IS DEFINED AS AN ANA TITER ≥ 1:80 AND/OR A POSITIVE ANTI-DSDNA (> THE ULN FOR THE CENTRAL LABORATORY REPORTED RESULT) SERUM ANTIBODY.
O
. ONE POSITIVE HISTORICAL TEST RESULT THAT IN THE OPINION OF THE INVESTIGATOR AND THE SPONSOR (SEE SUBJECT SELECTION ABOVE) IS UNEQUIVOCALLY DUE TO SLE. HISTORICAL DOCUMENTATION OF A POSITIVE TEST OF ANA (EG,ANA BY HEP-2 TITER, ANA BY ELISA) OR ANTI-DSDNA (EG, ANTI-DSDNA BY FARR ASSAY OR ELISA) MUST INCLUDE THE DATE AND TYPE OF THE TEST, THE TESTING LABORATORY NAME, NUMERICAL REFERENCE RANGE, AND
1. ANY PRIOR HISTORY OF TREATMENT WITH PF-04236921, OR ANTI-IL-6 AGENT.
2. HAVE RECEIVED ANY OF THE FOLLOWING WITHIN 364 DAYS OF DAY 1:
. A BIOLOGIC INVESTIGATIONAL AGENT OTHER THAN THOSE NOTED BELOW (EG, ABATACEPT OR INTERFERON ALPHA INHIBITORS). (INVESTIGATIONAL AGENT IS DEFINED AS ANY DRUG NOT APPOVED FOR SALE IN THE COUNTRY IN WHICH IT IS BEING USED).
. HAVE REQUIRED 3 OR MORE COURSES OF SYSTEMIC CORTICOSTEROIDS FOR CONCOMITANT CONDITIONS (EG, ASTHMA, CROHHN´S DISEASE, ULCERATIVE COLITIS, SYSTEMIC VASCULITIS, ATOPIC DERMATITIS) WITHIN 364 DAYS OD DAY 1 (TOPICAL OR INHALET STEROIDS ARE PERMITTED).
3. RECEIVED IV CYCLOPHOSPHAMIDE WITHIN 180 DAYS OF DAY 1.
4. HAVE RECEIVED ANY OF THE FOLLOWING WITHIN 90 DAYS OF DAY 1:
. ANTI-TNF THERAPY (EG, ADALIMUMAB, ETANERCEPT, INFLIXIMAB).
. INTERLEUKIN-1 RECEPTOR ANTAGONIST (ANAKINRA).
. INTRAVENOUS IMMUNOGLOBULIN (IVIG).
. HIGH DOSE CORTICOSTEROIDS (> 100 MG/DAY PREDNISONE OR EQUIVALENT) OR PULSE IV DOSES.
. PLASMAPHERESIS.
5. HAVE RECEIVED ANY THE FOLLOWING WITUIN 60 DAYS OF DAY 1:
.ANY INTRAMUSCULAR, OR INTRAVENOUS STEROID INJECTION.
. ANY NEW IMMUNOSUPPRESSIVE/IMMUNOMODULATORY AGENT, OR ANTI-MALARIAL AGENT. (SEE INCLUSION CRITERIA # 7). NEW INHALED AND/OR NEW TOPICAL IMMUNOSUPPRESSIVE AGENTS (EG, EYE DROPS, TOPICAL CREAMS) ARE ALLOWED.
6. HAVE RECEIVED ANY OF THE FOLLOWING WITHIN 30 DAYS OF DAY 1:
. A LIVE VACCINE.
. ANY NEW OR CHANGE
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method