Examination of Efficacy and Safety of Baricitinib in RA Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 4 October 2021
• Main ID: NCT03755466
• Date of registration: 21/11/2018
• Prospective Registration: Yes
• Primary sponsor: Shinshu University
• Public title: Examination of Efficacy and Safety of Baricitinib in RA Patients
• Scientific title: Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib
• Date of first enrolment: November 21, 2018
• Target sample size: 90
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03755466
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 2

Countries of recruitment

Japan

Contacts

• Name: Yukio Nakamura, MD, PhD

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: "Baricitinib", "olumiant®"

Drug: "Biologics"

Drug: Tofacitinib 5 MG [Xeljanz]

Primary Outcome(s)

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. [Time Frame: Change from Baseline Values of DAS28-CRP at 1 year in each group]

Secondary ID(s)

BARI2018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors