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

Launched by BANGABANDHU SHEIKH MUJIB MEDICAL UNIVERSITY, DHAKA, BANGLADESH · Dec 13, 2022

Keywords

ClinConnect Summary

This open label randomized controlled clinical trial will be conducted in the department of Rheumatology, BSMMU. The rheumatoid arthritis patients with moderate to severe disease activity (DAS 28 ESR/CRP\>3.2) despite treatment with methotrexate or other csDMARDs will be considered as primary entry criteria for this study. Simple random sampling method will be applied. After a washout period of three weeks, Group A will be put on baricitinib 2 mg once daily and Group B will be put on baricitinib 4 mg once daily. Methotrexate 10mg will be used on both groups in addition to barcitinib. NSAIDs...

Gender

ALL

Eligibility 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

Trial Officials