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

• Status: Recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Criteria

Inclusion Criteria:

• 1. age greater than 18 years 2. patients fulfill the ACR/EULAR 2010 classification criteria for RA 3.DAS-28 CRP more than 3.2 despite optimum dose of methotrexate

Exclusion Criteria:

• 1. Recent or concurrent infection including active or latent tuberculosis except patients with latent tuberculosis in whom treatment was commenced ≥ 4 weeks before randomization

2. Hemoglobin (Hb) < 8 g/dl 3. White blood cell count < 4000, Neutrophil count < 1000, Platelet count < 100000/mm3 4. Live vaccines within 3 months prior to the first dose

5. Serum creatinine > upper limit of normal reference range 6. eGFR < 60 ml/minute/1.73 m2 7. Alanine transaminase (ALT) more than ULN 8. Pregnant or breast feeding females of child-bearing potential 9. Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ 10. New York Heart Association Class III and IV congestive heart failure 11. Previous history of thromboembolism, deep venous thrombosis, diverticulitis