Examination of Efficacy and Safety of Baricitinib in RA Patients

Sponsor
Shinshu University
Study ID
NCT03755466
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Nov 21, 2018
Status verified
Sep 2021
Primary completion
Nov 20, 2023
Completion
Nov 20, 2025

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: BARI
  • Active Comparator: Bio
  • Active Comparator: Tofa

Primary Outcome Measure

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 ]

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