None listed
Conditions
Interventions
RECRUITMENT OF SUBJECTS WILL BE RESTRICTED TO THOSE WITH CLINICALLY ACTIVE SLE DISEASE DEFINED AS A SAFETY OF ESTROGEN IN LUPUS NATIONAL ASSESSMENT TRIAL (SELENA) SYSTEMIC LUPUS ERYTHEMATOSUS DISEASE
8, THE PRESENCE OF AUTO ANTIBODIES TO NUCLEAR COMPONENTS (ANA+ AND/OR DSDNA+) AND AN ABSENCE OF SIGNIFICANT RENAL OR CNS ORGAN MANIFESTATIONS. IT IS EXPECTED THAT APPROXIMATELY 150 TO 250 PATIENTS WIL
HOWEVER, THE EXACT NUMBER WILL BE DETERMINED FOLLOWING ANALYSES OF DATA AT INTERIM ANALYSES 1, 2 AND IF CONDUCTED FOLLOWING ANALYSIS OF DATA AT INTERIM ANALYSIS 3. SAMPLE SIZE RE-ESTIMATION WILL BE PE
15 MG/DAY PREDNISONE OR PREDNISONE EQUIVALENT OR LESS) FOR A MINIMUM OF 30 DAYS PRIOR TO SCREENING AND THROUGH TO DAY 0/RANDOMISATION AND /OR HYDROXYCHLOROQUINE (≤
400 MG DAILY DOSE) FOR A MINIMUM OF 60 DAYS PRIOR TO THE DAY 0/RANDOMISATION VISIT. SUBJECTS WHO ARE RECEIVING AZATHIOPRINE (≤
2 MG/KG/DAY OR ≤
150 MG/DAY) OR MYCOPHENOLATE MOFETIL (≤
1.5 G/DAY) OR METHOTREXATE (MTX, ≤
20 MG/WEEK), IN ADDITION TO STEROIDS AND / OR HYDROXYCHLOROQUINE WILL BE RECRUITED IF THEY HAVE BEEN ON A STABLE DOSE OF AZATHIOPRINE
Sponsors
GlaxoSmithKline,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. AGE AND GENDER: MALE OR FEMALE BETWEEN 18 AND 75 YEARS OF AGE INCLUSIVE, AT THE TIME OF SIGNING THE INFORMED CONSENT. 2. SLE CLASSIFICATION: HAVE A CLINICAL DIAGNOSIS OF SLE ACCORDING TO THE AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) CLASSIFICATION CRITERIA, WITH 4 OR MORE OF THE 11 ACR CRITERIA PRESENT, SERIALLY OR SIMULTANEOUSLY DURING ANY INTERVAL OR OBSERVATION (SEE APPENDIX 2). 3. SEVERITY OF DISEASE: HAVE CLINICALLY ACTIVE SLE DISEASE DEFINED AS A SELENA SLEDAI SCORE ≥ 8 AT SCREENING. 4. AUTO ANTIBODIES: ARE SEROLOGICALLY ACTIVE HAVING UNEQUIVOCALLY POSITIVE ANTI¬NUCLEAR ANTIBODY (ANA) OR ANTI-DOUBLE STRANDED DNA (ANTI-DSDNA) ANTIBODY TEST RESULTS FROM 2 INDEPENDENT TIME POINTS AS FOLLOWS: . POSITIVE TEST RESULTS FROM 2 INDEPENDENT TIME POINTS WITHIN THE STUDY SCREENING PERIOD. SCREENING RESULTS MUST BE BASED ON THE STUDY´S CENTRAL LABORATORY RESULTS. A POSITIVE TEST IS DEFINED AS A POSITIVE ANA TEST EQUIVALENT TO A TITRE ≥ 1:80 AS DEFINED IN THE CENTRAL LABORATORY MANUAL AND/OR A POSITIVE ANTI-DSDNA (≥ 30 IU/ML) SERUM ANTIBODY. OR . ONE POSITIVE HISTORICAL TEST RESULT AND 1 POSITIVE TEST RESULT FOR EITHER ANA OR ANTI-DSDNA DURING THE SCREENING PERIOD.
Exclusion criteria
Exclusion criteria: 1. KIDNEY DISEASE: HAVE KIDNEY DISEASE MEETING THE FOLLOWING DEFINITION: PROTEINURIA > 0.5G/24 HOUR OR EQUIVALENT SPOT URINE PROTEIN TO CREATININE RATIO OF 0.5MG/MG OR; SERUM CREATININE > 1.5 X UPPER LIMIT OF NORMAL (ULN) OR; HAVE ACTIVE NEPHRITIS REQUIRING ACUTE THERAPY NOT PERMITTED BY PROTOCOL (E.G., INTRAVENOUS (IV) CYCLOPHOSPHAMIDE) OR; HAVE REQUIRED PERITONEAL DIALYSIS OR HEMODIALYSIS OR HIGH DOSE CORTICOSTEROID (> 100 MG/DAY PREDNISONE OR EQUIVALENT) WITHIN 90 DAYS PRIOR TO FIRST DOSE OR; HAVE HAD ACTIVE RENAL DISEASE SHOWN ON RENAL BIOPSY IN THE THREE MONTHS PRIOR TO SCREENING. 2. CNS DISEASE: HAVE ACTIVE CENTRAL NERVOUS SYSTEM (CNS) LUPUS (INCLUDING SEIZURES, PSYCHOSIS, ORGANIC BRAIN SYNDROME, CEREBROVASCULAR ACCIDENT [CVA], CEREBRITIS OR CNS VASCULITIS) REQUIRING THERAPEUTIC INTERVENTION WITHIN 60 DAYS PRIOR TO FIRST DOSE. 3. ALCOHOL ABUSE: EVIDENCE OR, IN THE OPINION OF THE INVESTIGATOR, SUSPICION OF ALCOHOL CONSUMPTION EXCEEDING NATIONAL GUIDELINES AND / OR SYMPTOMS OF ALCOHOL DEPENDENCY. 4. SUBSTANCE ABUSE: HAVE EVIDENCE OF CURRENT RECREATIONAL DRUG ABUSE OR DEPENDENCE.
Countries
Belgium
Contacts
Public ContactPatricia Lopez
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed