Glucocorticoids, Systemic Lupus Erythematosus, Therapy Withdrawal
Conditions
Brief summary
This is a 36 months, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive Systemic Lupus Erythematosus to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids in patients on stable clinical remission or low disease activity.
Interventions
DRUGoral Prednisone 5mg
patients randomized to this arm will stop prednisone 5 mg
Sponsors
University of Pisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
This is a 36 month, randomized, double-blind, placebo-controlled, parallel-groups, equivalence multicenter trial in patients with inactive SLE to evaluate if low disease activity can be sustained with withdrawal of glucocorticoids
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of SLE according to the EULAR/ACR criteria within three years from screening visit * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national subject privacy regulations * Aged 18 to 75 years old, inclusive, at the time of informed consent * Documented diagnosis of SLE according to the current ACR criteria * Stable immunosuppressive treatment for SLE for a minimum of one year/six months * Stable treatment with antimalarials for a minimum of 3 months * stable (lasting for at least 6 months) low disease activity
Exclusion criteria
* Disease activity (non LLDAS) within 6 months prior to screening * Concomitant ongoing conditions (e.g. asthma, Crohn's disease) that require treatment with systemic GC (excluding topical or inhaled GC). * Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, social) likely to affect the subject returning for follow-up visits on schedule * Nursing mothers, pregnant women or women planning to become pregnant during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease flare | 35 months | The primary endpoint is the proportion of patients who will experience a disease during the follow-up period in the groups given prednisone 5 mg or placebo in the double-blind period. |
Contacts
Primary ContactMarta Mosca, MD
Backup ContactChiara Tani, MD
Outcome results
None listed