Use of Baricitenib to Maintain of Remission

January 13, 2023 updated by: Manal Hassanien, Assiut University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Yes
      • Assiut, Yes, Egypt, 7111
        • Recruiting
        • Manal Hassanien
        • Contact:
        • Contact:
        • Principal Investigator:
          • Helal Hetta, MD
        • Sub-Investigator:
          • Sonya Rashad, Prof
        • Sub-Investigator:
          • Abdelhafeez Moshrif

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

December 25, 2022

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Estimate)

January 16, 2023

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • systemic lupus

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

after finishing study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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