None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Belimumab, at a dose of 1mg / kg, in IV infusion, for one hour, on days 0, 14, 28 and then every 28 days, up to 48 weeks. Patients will continue with their usual medications.
Group name:GROUP 3 Type of group
This group will be treated with Belimumab Placebo, in IV infusion, for one hour, on days 0, 14, 28 and then every 28 days, up to 48 weeks. Patients will continue with their usual medications.
Sponsors
HUMAN GENOME SCIENCES, INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Be at least 18 years of age. 2. Have a clinical diagnosis of SLE according to the criteria of the American College of Rheumatology. 3. Have active SLE disease defined according to a SELENA SLEDAI Rating ≥ 6 in the evaluation. 4. Have unequivocally positive antinuclear antibody (ANA) results at 2 independent time points. 5. Have a stable treatment regimen for SLE. 6. Subjects with angiotensin-channel antihypertensive drugs should be in stable regimen for a period of at least 30 days before Day 0. 7. Subjects with HMG CoA reductase inhibitors should be in stable regimen for a period of at least 30 days before Day 0. 8. A female subject is eligible to enter the study if: A) She is not pregnant or breastfeeding; B) Does not have pregnancy potential or C) Is of childbearing age and has a negative pregnancy test in the evaluation, and must use 1 of the acceptable contraceptive methods. 9. A male subject is eligible to enter the study if they agree to use a contraceptive method during the study and for 3 months after the last dose of the study medication. 10. Have the ability to understand the requirements of the study, provide written informed consent and adhere to the procedures of the study protocol.
Exclusion criteria
Exclusion criteria: 1, Having received treatment with any treatment directed to B lymphocytes at any time. 2. Have received any of the following, in the 364 days prior to Day 0: a) Abatacept. b) A biological agent in research other than treatment directed to B lymphocytes. 3. Have required 3 or more cycles of systemic corticosteroids for concomitant conditions in the 364 days prior to Day 0. 4. Having received intravenous cyclophosphamide (IV) in the 180 days prior to Day 0. 5. Have received any of the following in the 90 days prior to Day 0: a) Anti-TNF treatment. b) Interleukin-1 receptor antagonists. c) Intravenous immunoglobulin (IVIG). d) High doses of prednisone. e) Plasmapheresis. 6. Have received any of the following, in the 60 days prior to Day 0: a) A non-biological agent in research. b) Any new immunosuppressive / immunomodulatory, antimalarial agent. NSAID, inhibitor of HMG CoA reductase or antihypertensive angiotensin. c) Any steroid injection. 7. Have received any of the following, within 30 days prior to Day 0: a) A live virus vaccine. b) A change in the dose of a corticosteroid, another immunosuppressive / immunomodulatory agent. antimalarial, NSAID, inhibitor of HMG CoA reductase or antihypertensive of the angiotensin pathway. 8. Have severe lupus kidney disease, or have active nephritis, or have required hemodialysis or prednisone at high doses in the 90 days prior to Day 0. 9. Have active lupus with involvement of the central nervous system (CNS) that requires therapeutic intervention in the 60 days prior to Day 0. 10. Having a history of a major organ transplant or hematopoietic stem cell transplant / bone marrow. 11. Have clinical evidence of significantly unstable or uncontrolled acute or chronic diseases not due to SLE. 12. Having a scheduled surgical procedure or history of any other medical illness, laboratory abnormality, or condition, which makes the subject unsuitable for the study. 13. Having a history of malignancy in the last 5 years. 14. Have required treatment of acute or chronic infections, namely: a) Currently with any suppressive treatment for a chronic infection. b) Hospitalization for treatment of infection in the 60 days prior to Day 0. c) Use of parenteral antibiotics in the 60 days prior to Day 0. 15. Currently have drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence in the 364 days prior to Day 0. 16. Have a positive test for antibody to HIV-1, hepatitis B surface antigen or antibody to hepatitis C. 17. Have an IgA deficiency. 18. Have a laboratory abnormality Grade 3 or higher. 19. Having a history of an anaphylactic reaction to the parenteral administration of contrast media, human or murine proteins or monoclonal antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation, to verify if the response criteria are met: 1) A decrease in the SELENA SLEDAI score (Study of the disease activity systemic lupus erythematosus - Index of activity of the systemic lupus erythematosus disease) ≥ 4 points from the basal. 2) Absence of worsening (increase <0.30 points from baseline) in the Global Physician Evaluation. 3) Absence of a BILAG A score new to the organ commitment or 2 BILAG B scores new to the organ commitment compared to the baseline. Measure:Response rate. Timepoints:Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Clinical evaluation of any unfavorable or unintended sign, symptom or disease that is temporarily associated with the use of the study medication. Criterion 2: Panels of hematology and serum chemistry. Criterion 3: Serum levels of anti-belimumab antibodies. Measure:Security: 1) Adverse events. 2) Laboratory parameters. 3) Immunogenicity. Timepoints:Criteria 1 and 2: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and during follow-up. Criterion 3: Day 0 and weeks 8, 24 and 52. ; Outcome name:Serum concentration of belimumab, by means of an enzyme-linked immunosorbent assay (ELISA). Measure:Pharmacokinetics. Timepoints:Weeks 2, 8, 24 and on day 364. ; Outcome name:Criterion 1: SELENA SLEDAI, evaluates the activity of SLE, based on multiple clinical and laboratory criteria. Criterion 2: General evaluation of the response, made by the attending physician. Criterion 3: Criterion 4: Abbreviated form of the health questionnaire-36 (SF-36), a 10-section questionnaire that assesses the impact of the disease on the patient. Criterion 4: Determination of the number of patients who reduced their dose of corticosteroids decreased ≥ 25% from baseline to ≤ 7.5 mg / day. Measure:Secondary Efficacy: 1) Percentage of subjects with a reduction of ≥ 4 points from the baseline in the SELENA SLEDAI score. 2) Average change in the EGM. 3) Average change in the summary score of the physical component (CF) of the SF-36 Health Questionnaire. 4) Percentage of subjects whose average dose of prednisone has decreased. Timepoints:Criterion 1: Week 52. Criteria 2 and 3: Week 24 Criterion 4: weeks 40 and 52. ; Outcome name:Criterion 1: Especially the mental component (CM) and each one of the qualifications of the 8 domains. Criterion 2: Functional evaluation of chronic disease treatment (FACIT), will assess the fatigue status of patients. Criteria 3 and | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia, India, Korea South, Philippines, Romania, Russian Federation, Taiwan
Contacts
Public ContactJACQUELINE ZEUNER
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed