Health Condition 1: null- Subjects having recently experienced a flare of system lupus erythematosus (SLE)
Conditions
Interventions
Intervention1: Drug: Atacicept 75mg: Dose is 75mg given subcutaneously (under the skin), twice a week for 4 weeks, and then once a week for 48 weeks
Intervention2: Drug: Atacicept 150mg: Dose is 150mg
Sponsors
Merck Serono International A Branch of Laboratories Serono SA
An affiliate of Merck KGaA, Darmstadt, Germany
9 Chemin des Mines
1211 Geneva, Switzerland
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosis of SLE satisfying at least 4 out of the 11 ACR criteria, with a disease duration of at least six months. 2.Active SLE with one BILAG score A or B at initial screening (excluding a single B due to haematological values) requiring a change in the dose of corticosteroids. 3.Positive antinuclear antibody (ANA) test results (HEp-2 ANA ³1:80 and/or anti-dsDNA ³30 IU/mL). (subjects will be tested at screening). 4.Male or female more than or equal to 16 years of age.
Exclusion criteria
Exclusion criteria: ? Active moderate to severe glomerulonephritis (kidney impairment) ? Active central nervous system SLE deemed to be severe/progressive ? Previous treatment with rituximab, abatacept, or belimumab ? Initiation of any immunosuppressive drug within 3 months before initial screening. ? Participation in any interventional clinical trial within the last 28 days or within 5 half-lives of the investigated compound (whichever is longer) before initial screening. ? Treatment with cyclophosphamide or a calcineurin inhibitor within 3 months of initial screening. ? Treatment with leflunomide, 6-mercaptopurine or thalidomide within 3 months before initial screening. ? Introduction of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine, or methotrexate within 2 months before initial screening or increase in the dose regimen of any of these medications within 2 months before initial screening. ? Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that constitutes a risk or a contraindication for participation to the study in the opinion of the Investigator or that could interfere with study objectives, conduct or evaluation ? Pregnant and Breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients experiencing a new flare as defined by a BILAG score of A or BTimepoint: 52 week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Corticosteroid exposureTimepoint: Post randomization;? Proportion of subjects with new flare (BILAG A or B)Timepoint: Within the initial 24 weeks after randomization;? Proportion of subjects within each of the following ordinal response categories : No flare, first a new flare scored as BILAG B and first new flare scored as BILAG ATimepoint: At week 52;Time to first new flareTimepoint: From the date ofrandomization | — |
Countries
India
Contacts
Public ContactBindya Cariappa
Merck Serono
Outcome results
None listed