Examination of Efficacy and Safety of Baricitinib in RA Patients

Phase 2

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: "Biologics"; Drug: "Baricitinib", "olumiant®"; Drug: Tofacitinib 5 MG [Xeljanz]

• Registration Number: NCT03755466
• Lead Sponsor: Shinshu University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-21
• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-23
• Study First Posted: 2018-11-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21
• Primary Completion: 2023-11-20
• Study Completion: 2025-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• RA patients

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BARI	"Biologics"	-
BARI	Tofacitinib 5 MG [Xeljanz]	-
Bio	"Baricitinib", "olumiant®"	-
Bio	Tofacitinib 5 MG [Xeljanz]	-
Tofa	"Baricitinib", "olumiant®"	-
Tofa	"Biologics"	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yukio Nakamura; 🇯🇵 Matsumoto, Nagano, Japan