Efficiency of Use of Baracetinib in Treatment of Lupus Nephritis

Study Overview
=================
Brief Summary
-----------------
Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus and had a diagnosis of systemic lupus erythematosus, and had active renal disease as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug.

Detailed Description
-----------------
Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus and had a diagnosis of systemic lupus erythematosus, and had active renal disease as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug. The baricitinib 4 mg dose suggestive to significantly improved the signs and symptoms of active systemic lupus erythematosus in patients who were not adequately controlled despite standard of care therapy, with a safety profile consistent with previous studies of baricitinib. This study provides the idea for future trials of JAK1/2 inhibition with baricitinib as a new potential oral therapy for

Official Title
-----------------
Efficiency of Baracetinib to Induce Remission of Active Lupus Nephritis

Conditions
-----------------
Lupus Nephritis

Intervention / Treatment
-----------------
* Drug: Anti JAK1,2
* Drug: Cyclophosphamid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lupus nephritis Exclusion Criteria: cardiac disease Thrombosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baracetinib<br>oral tablet 4 mg baricitinib and placebo IV infusion/ month | Drug: Anti JAK1,2<br>* Induction of remission of active lupus nephritis<br>* Other names: Baritava;|
| Active Comparator: Cyclophosphamide<br>IV cyclophosphamide 0.7mg/m2 every month and placebo tablet daily | Drug: Cyclophosphamid<br>* Induction of remission of active lupus nephritis<br>* Other names: Indoxan;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Album in urine | 24 h protein in urine | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complement 3 | serum level | 3 and 6 months | 
| anti double strand DNA | serum level | 3 and 6 months | 
| lupus activity index-2K | SLEDAI-2k | 3 and 6 months |