Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus
NCT03804723 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 321
Last updated 2019-01-18
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.
Conditions
- Systemic Lupus Erythematosus
- Glucocorticoids
- Therapy Withdrawal
Interventions
- DRUG
-
oral Prednisone 5mg
patients randomized to this arm will stop prednisone 5 mg
Sponsors & Collaborators
-
University of Pisa
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-06-30
- Primary Completion
- 2022-06-30
- Completion
- 2023-09-30
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