Examination of Efficacy and Safety of Baricitinib in RA Patients

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03755466

Enrollment

Registered

2018-11-28

Start date

2018-11-21

Completion date

2025-11-20

Last updated

2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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

Interventions

DRUGBaricitinib, olumiant®

To examine the effects of baricitinib in RA patients

DRUGBiologics

To examine the effects of biologics in RA patients

DRUGTofacitinib 5 MG [Xeljanz]

To examine the effects of tofacitinib in RA patients

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026