SLE systemic lupus
Conditions
Interventions
Hiervoor verwijzen wij graag naar de study flowchart in het protocol, pagina
114/115 en pagina 58 van het protocol (dosage and administration).
Sponsors
Merck BV - An affiliate of Merck Serono S.A.
Eligibility
Age
12 Years to 64 Years
Inclusion criteria
Inclusion criteria: Complete lists of inclusion and exclusion criteria may be found in Section 5.2.;The trial will enrol subjects from 16 years old of either gender who have a diagnosis of SLE satisfying at least 4 of the 11 ACR criteria and a disease history of at least six months. Eligible subjects must have active SLE with at least one BILAG A or B score at screening (excluding a single B due to haematological values) requiring a change in the dose of corticosteroids, and must have a positive antinuclear antibody (ANA) test (HEp-2 ANA 1:80 and/or anti-dsDNA 30 IU/mL) at the initial screening visit.
Exclusion criteria
Exclusion criteria: Complete lists of inclusion and exclusion criteria may be found in Section 5.2.;Subjects who have active moderate to severe glomerulonephritis will be excluded, as will those who have received any treatment with rituximab, abatacept or belimumab, those who have initiated new immunosuppressive drugs or have used cyclophosphamide, calcineurin inhibitors or investigational treatments within specified periods before screening, those who have had introduction of or increases in treatment regimen of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine or methotrexate within 2 months before the screening visit, and those who have clinically significant abnormalities on screening laboratory tests, or who have any condition that in the Investigator*s opinion constitutes a risk or a contraindication for participation to the trial or that could interfere with the trial objectives, conduct or evaluation. Pregnant women and breastfeeding women will also be excluded. History of any demyelinating disease, such as MS or ON.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: The primary efficacy endpoint will be the proportion of subjects experiencing a new flare (as defined by a British Isles Lupus Assessment Group [BILAG] score of A or B) during the 52- week treatment period following randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| SECONDARY Secondary efficacy endpoints will include: • Time to first new flare from randomisation (main secondary endpoint). • Proportions of subjects within each of the following ordinal response categories at Week 52: No flare, first new flare scored as BILAG B and first new flare scored as BILAG A. • Proportion of subjects with a new flare (BILAG A or B) within the initial 24 weeks after randomisation. • Corticosteroid exposure post-randomisation. TERTIAIRY • Number of flares per subject over 52 weeks. • Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) score over time. Quality of Life (QOL), as measured by the Krupp Fatigue Severity Scale (KFSS) and the Medical Outcomes Study Short Form General Health Survey (SF-36) over time. • Change from baseline in Systemic Lupus International Collaborating Clinics (SLICC) damage score at Week 52. • Numerical BILAG score over time. • Proportion of subjects for whom immunosuppressive treatment or high-dose corticosteroids are initiated during the trial. High-dose corticosteroids are defined as 20 mg or more of prednisone or equivalent doses of other corticosteroids. The following tertiary endpoints will be assessed at Week 24 and at Week 52, respectively: • Changes from baseline in anti-nuclear antibodies (ANA), anti-double-stranded (ds)DNA antibodies and complement levels. • Proportion of subjects who maintain a BILAG C or BILAG D from randomisation. • Proportion of subjects with baseline C3 below normal limits who have normal C3 values. • Proportion of subjects with baseline C4 below normal limits who have normal C4 values. • Proportion of subjects with positive anti-dsDNA antibody levels at baseline who have negative results. Safety Endpoints: • Nature, severity and incidence of adverse events. • Incidence and severity of laboratory abnormalities. • Proportion of subjects who develop binding and/or | — |
Countries
Netherlands
Outcome results
None listed