Lupus or SLE, Nephritis
Conditions
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.
Interventions
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
participant and investigator and outcome assessor
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Lupus nephritis Disease * Must be able to swallow tablets * lupus nephritis in remission
Exclusion criteria
* antiphospholipid syndrome disease * thrombosis history * sever anemia, leukopenia or thrombocytopenia * impaired liver and renal function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proteins creatinine ratio | 3 months | nephritis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complement 3 | 3 months | serum level |
| anti ds DNA | 3 months | serum level |
| ANA | 3 months | serum level |
Countries
Egypt
Contacts
Primary ContactManal Hassanien, MD
Outcome results
None listed