Back to resultsGlucocorticoids Withdrawal in Early Systemic Lupus Erythematosus
Primary Purpose
Systemic Lupus Erythematosus, Glucocorticoids, Therapy Withdrawal
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oral Prednisone 5mg
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GC withdrawal
non GC withdrawal
Arm Description
Outcomes
Primary Outcome Measures
disease flare
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03804723
Brief Title
Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus
Official Title
Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2019 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Glucocorticoids, Therapy Withdrawal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
321 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GC withdrawal
Arm Type
Experimental
Arm Title
non GC withdrawal
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
oral Prednisone 5mg
Intervention Description
patients randomized to this arm will stop prednisone 5 mg
Primary Outcome Measure Information:
Title
disease flare
Description
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.
Time Frame
35 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Mosca, MD
Phone
050992519
Email
marta.mosca@med.inipi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Chiara Tani, MD
Email
chiara.tani@ao-pisa.toscana.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus
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