Use of Baricitenib to Maintain of Remission

NCT ID: NCT05686746

Last Updated: 2023-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-08-01

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.

Conditions

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Lupus or SLE Nephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
participant and investigator and outcome assessor

Study Groups

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Baricetinib 4 mg

4 mg oral tablet daily

Group Type EXPERIMENTAL

Baricitinib 4 MG

Intervention Type DRUG

4 mg oral daily

Baricetinib 2 mg

2 mg oral tablet daily

Group Type EXPERIMENTAL

Baricitinib 2 MG

Intervention Type DRUG

2 mg oral daily

MMF

MMF 500 mg tablet twice daily

Group Type ACTIVE_COMPARATOR

MMF

Intervention Type DRUG

1000 mg oral daily

Interventions

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Baricitinib 4 MG

4 mg oral daily

Intervention Type DRUG

Baricitinib 2 MG

2 mg oral daily

Intervention Type DRUG

MMF

1000 mg oral daily

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Manal Hassanien

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manal Hassanien, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Manal Hassanien

Asyut, Yes, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Manal Hassanien, MD

Role: CONTACT

00201062679200

Facility Contacts

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Manal M Hassanien, MD

Role: primary

+201062679200

Manal Hassanien

Role: backup

+201062679200

Other Identifiers

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systemic lupus

Identifier Type: -

Identifier Source: org_study_id

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