There is debate as to whether long-term low-dose steroids such as prednisolone help to suppress relapses of systemic lupus erythematosus (SLE) in patients who are in remission from their lupus nephritis. If low-dose prednisolone reduces relapses, these beneficial effects may be counter-balanced by the long-term side-effects associated with prednisolone. This pilot study will determine the feasibility of conducting a larger randomized control trial that will answer the question of whether or not long-term low-dose prednisolone (5 - 7.5 mg/day) reduces the flares of SLE in patients with previous lupus nephritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
5 - 7.5 mg/day
Matched placebo to prednisolone
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Feasibility (recruitment rate and protocol adherence)
Time frame: 12 months
1) time to major renal and non-renal relapses of SLE 2) time to minor relapses of SLE 3) health related quality of life 4) adverse events/side-effects 5) accrual of SLE related organ damage 6) renal function
Time frame: 24 months
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