None listed
Conditions
Interventions
Group 1 Type of group
A-623 100 mg subcutaneously (SC) every week for up to 52 weeks of treatment
Group name:Group 4 Type of group
placebo for up to 52 weeks of treatment
Sponsors
Anthera Pharmaceuticals, Inc.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of SLE according to the guidelines of the American College of Rheumatology. • Standard care treatment for at least 2 months and a stable dosing regimen for> 30 days prior to randomization (standard care medications include NSAIDs, antimalarial drugs, corticosteroids, methotrexate, azathioprine, leflunomide and mofetil [ 6 in the selection. • Serologically active as defined by the antinuclear antibody (ANA)> 1:80 (IFA titer using the Hep2 cell line) and / or double stranded anti-DNA (anti-ds DNA)> 30 lU / ml at the time of selection . • Age> 18 years. • They are receiving a stable dose of prednisone between 7.5 mg and 40 mg per day for> 30 days. They may be at doses <7.5 mg / day or without prednisone, if they receive at least one other medication for SLE (refer to the medications listed in Inclusion 2 above).
Exclusion criteria
Exclusion criteria: • A disorder (including psychiatric), clinically significant condition or disease (other than a diagnosis of SLE) that would interfere with the evaluation, termination and / or study procedures according to the investigator´s criteria. This includes any comorbidity such as the presence of congestive heart failure, angina, chronic obstructive disease and lung disease. • Active vasculitis (defined as gangrene or acute ischemic infarction), active central nervous system lupus (CNS), active lupus nephritis, uncontrolled hypertension (> 160/90 mm Hg) or uncontrolled diabetes (according to the clinical criteria of the researcher) . • Have a positive test for human immunodeficiency virus (HIV) and / or a positive test at the selection visit for hepatitis B surface antigen or hepatitis C virus. • Liver disease (alanine aminotransferase [ALT] or serum aspartate aminotransferase [AST]> 3 times the upper limit of normal [ULN]). • Anemia (Hgb <8 g / dl), neutropenia (<1500 cells / ul) or thrombocytopenia (<50,000 cells / ul). If the condition is considered to be due to SLE, the subject may be included after discussing it with the medical monitor. • Malignant neoplasm in the last 5 years (apart from squamous cell carcinoma or basal cell carcinoma of the skin that has been removed and considered cured). • Active infection that requires hospitalization or treatment with parenteral antibiotics in the last 60 days or a history of repeated viral infections (an infection is defined as more than 2 episodes in the 2 years prior to selection). • History of active tuberculosis or a history of positive screening test for latent Mycobacterium tuberculosis infection. • Any previous administration of the A-623. • Participation in the treatment group with active substance in any phase 2 or phase 3 clinical trial for a molecule that is primarily directed to the B lymphocyte pathway (for example, bellmumab, TACi-lg) in the last 18 months. • Prior administration of any 8 lymphocyte reduction therapy (such as anti-CD20 or anti-CD22 molecules) in the last 18 months. • Administration of cyclophosphamide, prednisone in high doses, cyclosporine, anti-TNFa therapies, transfusion, plasma exchange or plasma exchange, IV immunoglobulin or live vaccines • Women who are breastfeeding, pregnant or trying to get pregnant during the time of the study, or who have a positive serum pregnancy test at baseline (if the subject is a woman with the possibility of pregnancy). Subjects with reproductive potential will require using a reliable method of birth control during the study and for 3 months after the termination of therapy. A reliable method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy or a double barrier method (diaphragm with foam or spermicidal gel, or a condom) or vasectomy Menopause is defined as the absence of menstrual cycles for at least 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The % of subjects with SLE response compared with baseline at the time of assessment Measure:SLE response Timepoints:Various timepoints through Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:the concentration of B lymphocytes is quantified as CD19 positive, CD20 positive and CD45 positive). This analysis will be performed using data from subjects with a baseline B lymphocyte concentration and a B lymphocyte concentration obtained during or after Week 16. Measure:B cell reduction Timepoints:Various timepoints through Week 52 ; Outcome name:It will be evaluated using a Cox proportional regression risk model with the linear, covariate, predictive and step-by-step tests of the hypotheses used in the model for the primary assessment criterion. Withdrawals due to an exacerbation will be considered events (as well as exacerbations); Withdrawals for other reasons will be evaluated at the time of the most recent visit. Measure:The time to the first flare Timepoints:Various timepoints through Week 52 ; Outcome name:It will be evaluated using a model with linear contrasts, covariates, predictors and stage reduction tests of the hypotheses used in the ANCOVA model for the primary assessment criterion. The most recent FACIT score of the subject will be used in the analysis. Subjects without a FACIT score after the base! They will be excluded from the analysis. Measure:FACIT-fatigue score Timepoints:Various timepoints through Week 52 ; Outcome name:It will be evaluated using analyte values from baseline and post-baseline time periods. Measure:The change from baseline in IgG, igM, C3, C4 and anti-ds DNA Timepoints:Various timepoints through Week 52 | — |
Countries
Argentina, Brazil, Chile, Colombia, Hong Kong, India, Mexico, Peru, Philippines, Taiwan, United States
Contacts
Public ContactMarcela Toledo
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed