Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03804723
• Date of registration: 11/01/2019
• Prospective Registration: Yes
• Primary sponsor: University of Pisa
• Public title: Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus
• Scientific title: Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial
• Date of first enrolment: June 2019
• Target sample size: 321
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03804723
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Contacts

• Name: Marta Mosca, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Therapy Withdrawal

Systemic Lupus Erythematosus

Glucocorticoids

Intervention(s)

Drug: oral Prednisone 5mg

Primary Outcome(s)

disease flare [Time Frame: 35 months]

Secondary ID(s)

001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors