Efficacy and Safety of Baricitinib for the Treatment of Moderate to Severe Rheumatoid Arthritis

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study ID
NCT05660655
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a randomized controlled study. Baricitinib 4mg in one arm and Baricitinib 2mg in another arm will be used. Methotrexate 10mg per week in both arms will be used.

Key Dates

Start date
Oct 1, 2022
Status verified
Nov 2023
Primary completion
Sep 30, 2023
Completion
Sep 30, 2023

Study Design

Enrollment
94 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Baricitinib 2mg and methotrexate 10mg
    Baricitinib 2mg once daily plus methotrexate 10mg per week
  • Experimental: Baricitinib 4mg and methotrexate 10mg
    Baricitinib 4mg once daily plus methotrexate 10mg per week

Primary Outcome Measure

Disease activity score 28-C-reactive protein (DAS28-CRP) [ Time Frame: 6 months ]

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