Use of Baricitenib to Maintain of Remission

Nephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05686746
• Other study ID #: systemic lupus
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: Manal Hassanien, MD
• Phone: 00201062679200
• Email: manal_hassanien[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Nephritis

Intervention

Drug:
• Baricitinib 4 MG
4 mg oral daily
• Baricitinib 2 MG
2 mg oral daily
• MMF
1000 mg oral daily

Locations

Country	Name	City	State
Egypt	Manal Hassanien	Assiut	Yes

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proteins creatinine ratio	nephritis	3 months
Primary	proteins creatinine ratio	nephritis	6 months
Primary	proteins creatinine ratio	nephritis	1 year
Secondary	complement 3	serum level	3 months
Secondary	complement 3	serum level	6 months
Secondary	complement 3	serum level	1 year
Secondary	anti ds DNA	serum level	3 months
Secondary	anti ds DNA	serum level	6 months
Secondary	anti ds DNA	serum level	1 year
Secondary	ANA	serum level	3 months
Secondary	ANA	serum level	6 months
Secondary	ANA	serum level	1 year