Use of Baricitenib to Maintain of Remission

Study Overview
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Brief Summary
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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
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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.

Official Title
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Uses of Baricetinib 4 mg or 2mg Versus MMF to Maintain Lupus Remission Randomized Controlled Trial: Outcomes Over 2 Years

Conditions
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Lupus or SLE, Nephritis

Intervention / Treatment
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* Drug: Baricitinib 4 MG
* Drug: Baricitinib 2 MG
* Drug: MMF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baricetinib 4 mg<br>4 mg oral tablet daily | Drug: Baricitinib 4 MG<br>* 4 mg oral daily<br>|
| Experimental: Baricetinib 2 mg<br>2 mg oral tablet daily | Drug: Baricitinib 2 MG<br>* 2 mg oral daily<br>|
| Active Comparator: MMF<br>MMF 500 mg tablet twice daily | Drug: MMF<br>* 1000 mg oral daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proteins creatinine ratio | nephritis | 3 months | 
| proteins creatinine ratio | nephritis | 6 months | 
| proteins creatinine ratio | nephritis | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complement 3 | serum level | 3 months | 
| complement 3 | serum level | 6 months | 
| complement 3 | serum level | 1 year | 
| anti ds DNA | serum level | 3 months | 
| anti ds DNA | serum level | 6 months | 
| anti ds DNA | serum level | 1 year | 
| ANA | serum level | 3 months | 
| ANA | serum level | 6 months | 
| ANA | serum level | 1 year |