NCT03755466

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. 1.Baricitinib treatment for 12 months
  2. 2.Biologics treatment for 12 months
  3. 3.Tofacitinib treatment for 12 months

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Nov 2018

Longer than P75 for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 21, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

5 years

First QC Date

November 21, 2018

Last Update Submit

September 20, 2021

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

BARI

ACTIVE COMPARATOR
Drug: "Biologics"Drug: Tofacitinib 5 MG [Xeljanz]

Bio

ACTIVE COMPARATOR
Drug: "Baricitinib", "olumiant®"Drug: Tofacitinib 5 MG [Xeljanz]

Tofa

ACTIVE COMPARATOR
Drug: "Baricitinib", "olumiant®"Drug: "Biologics"

Interventions

"Baricitinib", "olumiant®"DRUG

To examine the effects of baricitinib in RA patients

BioTofa
"Biologics"DRUG

To examine the effects of biologics in RA patients

BARITofa
Tofacitinib 5 MG [Xeljanz]DRUG

To examine the effects of tofacitinib in RA patients

BARIBio

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • RA patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yukio Nakamura

Matsumoto, Nagano, 3908621, Japan

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

baricitinibBiological Productstofacitinib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at Shinshu University School of Medicine

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 28, 2018

Study Start

November 21, 2018

Primary Completion

November 20, 2023

Study Completion

November 20, 2025

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)