None listed
Conditions
Interventions
Belimumab study agent is provided as a sterile, lyophilized product for injectable solution. Upon reconstitution with
4.8 mL sterile water for injection (SWFI), each vial delivers 400 mg belimumab
Sponsors
HUMAN GENOME SCIENCES, INC.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Males or females ≥ 18 years. 2. Have a diagnosis of SLE, refer to ACR revised criteria for the classification of SLE (Appendix 1) as a guide for diagnosis of SLE. 3. Active, autoantibody positive SLE (autoantibody positive is defined as the presence of ANA or anti-dsDNA antibodies). 4. Are on a SLE treatment regimen consisting of any of the following medications (alone or in combination): • Corticosteroids • Other immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), calcineurin inhibitors (eg, tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine, or thalidomide. • Anti-malarials [eg, hydroxychloroquine, chloroquine, quinacrine (mepacrine)] 5. A female subject is eligible to enter the study if she is: • Not pregnant or nursing; • Of non-childbearing potential (ie, women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation or any other permanent method of female sterilization); or • Of childbearing potential (ie, women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative urine pregnancy test at screening, and agree to 1 of the following: -Complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent until 16 weeks after the last dose of study agent; or - Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the study agent, during the study and 16 weeks after the last dose of study agent: ◦ Implants of levonorgestrel or etonogestrel; ◦ Injectable progesterone; ◦ Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; ◦ Oral contraceptives (either combined or progesterone only); ◦ Ethinyl estradiol/Etonogestrel vaginal ring; ◦ Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; ◦ Transdermal contraceptive patch; ◦ Male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for the female subject. Note: MMF and other forms of mycophenolate affect the metabolism of oral contraceptives and may reduce their effectiveness. As such, women receiving mycophenolate who are using oral contraceptives for birth control should employ an additional method (eg, barrier method). 6. Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures.
Exclusion criteria
Exclusion criteria: 1. Have received any prior treatment with belimumab, either as a marketed product or as an investigational agent. 2. Have received treatment with B cell targeted therapy (eg, rituximab, other anti-CD20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI-Fc, anti-BAFF [LY2127399]) within 364 days of Day 0. 3. Have received any of the following within 90 days of Day 0: • Any biologic agent (eg, adalimumab, etanercept, infliximab, anakinra) other than B cell targeted therapy (see Exclusion Criterion 2). • Plasmapheresis. 4. Have received any of the following within 60 days of Day 0: • A non-biologic investigational agent. 5. Have received any of the following within 30 days of Day 0: • A live vaccine. 6. Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix. 7. Have required management of acute or chronic infections, as follows: • Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria). • Hospitalization for treatment of infection within 60 days of Day 0. • Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 60 days of Day 0. 8. Have severe lupus kidney disease (defined by proteinuria > 6 g/24 hour or equivalent using spot urine protein to creatinine ratio, or serum creatinine > 2.5 mg/dL), or have severe active nephritis requiring acute therapy, or have required hemodialysis or high-dose prednisone or equivalent (> 100 mg/day) within 90 days of Day 0. 9. Have severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis) requiring therapeutic intervention. 10. Known HIV infection. 11. Current or history of hepatitis B or hepatitis C infection
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Estonia, India, Indonesia, Italy, Korea South, Lithuania, Malasya, Mexico, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Switzerland, Taiwan, Ukraine, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed