Examination of Efficacy and Safety of Baricitinib in RA Patients

NCT ID: NCT03755466

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-21

Study Completion Date

2025-11-20

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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BARI

Group Type ACTIVE_COMPARATOR

"Biologics"

Intervention Type DRUG

To examine the effects of biologics in RA patients

Tofacitinib 5 MG [Xeljanz]

Intervention Type DRUG

To examine the effects of tofacitinib in RA patients

Bio

Group Type ACTIVE_COMPARATOR

"Baricitinib", "olumiant®"

Intervention Type DRUG

To examine the effects of baricitinib in RA patients

Tofacitinib 5 MG [Xeljanz]

Intervention Type DRUG

To examine the effects of tofacitinib in RA patients

Tofa

Group Type ACTIVE_COMPARATOR

"Baricitinib", "olumiant®"

Intervention Type DRUG

To examine the effects of baricitinib in RA patients

"Biologics"

Intervention Type DRUG

To examine the effects of biologics in RA patients

Interventions

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"Baricitinib", "olumiant®"

To examine the effects of baricitinib in RA patients

Intervention Type DRUG

"Biologics"

To examine the effects of biologics in RA patients

Intervention Type DRUG

Tofacitinib 5 MG [Xeljanz]

To examine the effects of tofacitinib in RA patients

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shinshu University

OTHER

Sponsor Role lead

Responsible Party

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Yukio Nakamura

Lecturer at Shinshu University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yukio Nakamura

Matsumoto, Nagano, Japan

Site Status RECRUITING

Countries

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Japan

Facility Contacts

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Yukio Nakamura, MD, PhD

Role: primary

+81-263-37-2659

Other Identifiers

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BARI2018

Identifier Type: -

Identifier Source: org_study_id

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