U.S. flag

An official website of the United States government

Skip to main page content
Recruiting

Examination of Efficacy and Safety of Baricitinib in RA Patients

ClinicalTrials.gov ID NCT03755466
Sponsor Shinshu University
Information provided by Yukio Nakamura, Shinshu University (Responsible Party)
Last Update Posted 2021-09-21
Bookmark

Study Overview

Brief Summary

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
Show less
Official Title
Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib
Conditions
Rheumatoid Arthritis
Intervention / Treatment
  • Drug: "Baricitinib", "olumiant®"
  • Drug: "Biologics"
  • Drug: Tofacitinib 5 MG [Xeljanz]
  • Drug: "Baricitinib", "olumiant®"
  • Drug: "Biologics"
  • Drug: Tofacitinib 5 MG [Xeljanz]
Other Study ID Numbers
  • BARI2018
Study Start (Actual)
2018-11-21
Primary Completion (Estimated)
2023-11-20
Study Completion (Estimated)
2025-11-20
Enrollment (Estimated)
90
Study Type
Interventional
Phase
Phase 2

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

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.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
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
Show less
Ages Eligible for Study
20 Years and older (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

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

/
Design Details
Primary Purpose : Treatment
Allocation : Non-Randomized
Interventional Model : Parallel Assignment
Masking : Single (Participant)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Active Comparator: BARI Intervention/Treatment 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

Participant Group/Arm Active Comparator: Bio Intervention/Treatment Drug: "Baricitinib", "olumiant®"
  • To examine the effects of baricitinib in RA patients

Drug: Tofacitinib 5 MG [Xeljanz]
  • To examine the effects of tofacitinib in RA patients

Participant Group/Arm Active Comparator: Tofa Intervention/Treatment Drug: "Baricitinib", "olumiant®"
  • To examine the effects of baricitinib in RA patients

Drug: "Biologics"
  • To examine the effects of biologics in RA patients

Primary Outcome Measures
Outcome Measure Measure Description 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. 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 Registration Dates
First Submitted
2018-11-21
First Submitted that Met QC Criteria
2018-11-23
First Posted
2018-11-28
Study Record Updates
Last Update Submitted that met QC Criteria
2021-09-20
Last Update Posted
2021-09-21
Last Verified
2021-09

More Information

/

Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No