Use of Baricitenib to Maintain of Remission | NCT05686746

Studies
Use of Baricitenib to Maintain of Remission

NCT05686746

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jan 17, 2023Actual

Enrollment

80Estimated

Phase

Phase 2Phase 3

Conditions

Lupus or SLE
Nephritis

Interventions

Baricitinib 4 MG
Baricitinib 2 MG
MMF

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Jun 1, 2023Estimated

Completion Date

Aug 1, 2023Estimated

First Submitted Date

Dec 25, 2022

First Submission Date that Met QC Criteria

Jan 13, 2023

First Posted Date

Jan 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2023

Last Update Posted Date

Jan 17, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Baricetinib 4 mg	Experimental	4 mg oral tablet daily	Drug: Baricitinib 4 MG
Baricetinib 2 mg	Experimental	2 mg oral tablet daily	Drug: Baricitinib 2 MG
MMF	Active Comparator	MMF 500 mg tablet twice daily	Drug: MMF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Baricitinib 4 MG	Drug	4 mg oral daily	Baricetinib 4 mg
Baricitinib 2 MG

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
complement 3	serum level	3 months
complement 3	serum level	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Manal Hassanien, MD	Contact	00201062679200		manal_hassanien@yahoo.com

Overall Officials

Name	Affiliation	Role
Manal Hassanien, MD	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Manal Hassanien	Recruiting	Asyut	Yes	7111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

after finishing study

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008180	Lupus Erythematosus, Systemic
D009393	Nephritis

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000596027	baricitinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided