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NCT03755466 Clinical Trial

Examination of Efficacy and Safety of Baricitinib in RA Patients

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03755466
Other study ID # BARI2018
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 21, 2018
Est. completion date November 20, 2025

Study information
Verified date September 2021
Source Shinshu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date November 20, 2025
Est. primary completion date November 20, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• "Baricitinib", "olumiant®"
To examine the effects of baricitinib in RA patients
• "Biologics"
To examine the effects of biologics in RA patients
• Tofacitinib 5 MG [Xeljanz]
To examine the effects of tofacitinib in RA patients

Locations
Country Name City State
Japan Yukio Nakamura Matsumoto Nagano

Sponsors (1)
Lead Sponsor Collaborator
Shinshu University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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