Use of Baricitenib to Maintain of Remission
- Conditions
- NephritisLupus or SLE
- Interventions
- Registration Number
- NCT05686746
- Lead Sponsor
- Assiut University
- Brief Summary
Baricitinib a selective Janus kinase (JAK) inhibitors 1\&2 have been recognized as a potential therapeutic option in systemic lupus (SLE), also known Baricitinib, a JAK inhibitor, has demonstrated efficacy and safety in the treatment of dermatitis and arthritis 1 ; however, no JAK inhibitor studies have been conducted in lupus nephritis (LN) maintain remission to date.
- Detailed Description
Baricitinib a selective Janus kinase (JAK) inhibitors 1\&2 have been recognized as a potential therapeutic option in systemic lupus (SLE), also known Baricitinib, a JAK inhibitor, has demonstrated efficacy and safety in the treatment of dermatitis and arthritis 1 ; however, no JAK inhibitor studies have been conducted in lupus nephritis (LN) maintain remission to date. Objectives: To assess the efficacy and safety of Baricitinib in patients (pts) with LN by dose 4mg versus 2 mg versus MMF 1 gm daily dose.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Clinical diagnosis of Lupus nephritis Disease
- Must be able to swallow tablets
- lupus nephritis in remission
- antiphospholipid syndrome disease
- thrombosis history
- sever anemia, leukopenia or thrombocytopenia
- impaired liver and renal function
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MMF MMF MMF 500 mg tablet twice daily Baricetinib 4 mg Baricitinib 4 MG 4 mg oral tablet daily Baricetinib 2 mg Baricitinib 2 MG 2 mg oral tablet daily
- Primary Outcome Measures
Name Time Method proteins creatinine ratio 1 year nephritis
- Secondary Outcome Measures
Name Time Method complement 3 1 year serum level
anti ds DNA 1 year serum level
ANA 1 year serum level
Trial Locations
- Locations (1)
Manal Hassanien
🇪🇬Assiut, Yes, Egypt