Examination of Efficacy and Safety of Baricitinib in RA Patients

Sponsor

Shinshu University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03755466

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Baricitinib treatment for 12 months
Biologics treatment for 12 months
Tofacitinib treatment for 12 months

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: "Baricitinib", "olumiant®" Drug: "Biologics" Drug: Tofacitinib 5 MG [Xeljanz]	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 21, 2018

Anticipated Primary Completion Date :

Nov 20, 2023

Anticipated Study Completion Date :

Nov 20, 2025

Arms and Interventions

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: "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
Active Comparator: Tofa	Drug: "Baricitinib", "olumiant®" To examine the effects of baricitinib in RA patients Drug: "Biologics" To examine the effects of biologics in RA patients

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: "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

Active Comparator: Tofa

Drug: "Baricitinib", "olumiant®"

To examine the effects of baricitinib in RA patients

Drug: "Biologics"

To examine the effects of biologics in RA patients

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yukio Nakamura	Matsumoto	Nagano	Japan	3908621

Sponsors and Collaborators

Shinshu University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yukio Nakamura, Lecturer at Shinshu University School of Medicine, Shinshu University

ClinicalTrials.gov Identifier:

NCT03755466

Other Study ID Numbers:

BARI2018

First Posted:

Nov 28, 2018

Last Update Posted:

Sep 21, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Tofacitinib

Study Results

No Results Posted as of Sep 21, 2021