Systemic Lupus Erythematosus (SLE) MedDRA version: 9.1 Level: LLT Classification code 10040967 Term: SLE
Conditions
Interventions
Trade Name: Subcuvia
Pharmaceutical Form: Solution for injection
Sponsors
Department of Rheumatology,University hospital,Lund
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Patients with SLE during active illness phase defined as SLEDAI 2K 4 or higher · Patients with skin or joint engagement and/or serositis, low-grade hemolytic anemia and vasculitis. · Patients aged > 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Patients with life-threatening manifestation including glomerulonephritis, neuropsychiatric involvement, systemic vasculitis · Patients with M-components with and without rheumatoid factor activity · Known hypersensitivity to any of the drug components · Bleeding disorder requiring treatment · Antiphospholipid syndrome · Severe infections, malignancy, severe cardiovascular disorder · Females who are currently pregnant or breast feeding, or who plan to become pregnant during the course of the study. · Patients treated with hydroxychlorochin, azathioprine, mycofenolate-mofetil and methotrexate if not on stable treatment for > 3 months · Patients treated with immunomodulating and/or cytostatic drugs (cyclophosphamide, ciclosporin-A within 6 months and anti-B cell therapy (rituximab) within 1 year. · Patients treated with anticoagulant drugs e.g. warfarin or heparin. Treatment with low dose of acetylsalicylic acid (trombyl® is allowed · Patients treated with Subcuvia® / or other immunoglobulin within the previous 12 months. · Patients who are participating in any other clinical studies, or who have participated in such a study within the previous six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the ability to conclude Prednisolone cessation plan in patients treated with Subcuvia, compared with patients who are not recevning additional Subcuvia treatment.;Secondary Objective: Safety Regression of illness and normalization of parameters such as autoantibody levels, plasma concentrations of complement components and cytokine levels.;Primary end point(s): Failure to perform reduction of Prednisolone according to a predetermined scheme due to new or recurring disease activity according to definitions given in the BILAG scoring system. | — |
Countries
Sweden
Outcome results
None listed