Examination of Efficacy and Safety of Baricitinib in RA Patients

September 20, 2021 updated by: Yukio Nakamura, Shinshu University

Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients:

  1. Baricitinib treatment for 12 months
  2. Biologics treatment for 12 months
  3. Tofacitinib treatment for 12 months

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Japan
    • Nagano
      • Matsumoto, Nagano, Japan, 3908621
        • Recruiting
        • Yukio Nakamura

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • RA patients

Exclusion Criteria:

  • Not RA patients
  • RA patients who are allergic to the drugs, refused to do this research, or who are pregnant

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BARI
Drug: "Biologics"
To examine the effects of biologics in RA patients
Drug: Tofacitinib 5 MG [Xeljanz]
To examine the effects of tofacitinib in RA patients
Active Comparator: Bio
Drug: Tofacitinib 5 MG [Xeljanz]
To examine the effects of tofacitinib in RA patients
Drug: "Baricitinib", "olumiant®"
To examine the effects of baricitinib in RA patients
Active Comparator: Tofa
Drug: "Biologics"
To examine the effects of biologics in RA patients
Drug: "Baricitinib", "olumiant®"
To examine the effects of baricitinib in RA patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of Disease Activity in rheumatoid patients for 1 year treated by baricitinib (N=30), biologics (N=30), or tofacitinib (N=30). Also, the efficacy and adverse event of each drug for 1 year in the RA patients.
Time Frame: Change from Baseline Values of DAS28-CRP at 1 year in each group
Change from Baseline Values of DAS28-CRP at 1 year in each group

Collaborators and Investigators

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

Sponsor

Shinshu 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)

November 21, 2018

Primary Completion (Anticipated)

November 20, 2023

Study Completion (Anticipated)

November 20, 2025

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

November 23, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BARI2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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