Baricitinib, Methotrexate as Monotherapy or Combination in the Treatment of Rheumatoid Arthritis - an Open Label Randomized Clinical Trial

• Status: Recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this open-label randomized clinical trial is to assess the efficacy of baricitinib 2 mg in comparison to methotrexate 25 mg as monotherapy followed by baricitinib 4 mg in comparison to methotrexate 10 mg and baricitinib 2 mg combination in patients with rheumatoid arthritis with moderate to severe disease activity. The main question it aims to answer:

• Is there any difference in the efficacy of baricitinib as monotherapy in comparison to methotrexate monotherapy or methotrexate-baricitinib combination in the treatment of rheumatoid arthritis

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• 1. Patients more than 18 years of age 2. Patients fulfill the ACR/EULAR 2010 classification criteria for Rheumatoid arthritis 3. Patients with DAS 28 ESR> 3.2

Exclusion Criteria:

• 1. Recent or concurrent infection including active tuberculosis 2. Haemoglobin (Hb) < 9 gm/dl 3. Total WBC count < 4000 / µL 4. Neutrophil count < 1200 / µL 5. Lymphocyte count < 750 / µL 6. AST/ALT > three times the upper limit of normal 7. Estimated glomerular filtration rate < 60 ml/minute/1.73 m2 8. Co-morbid illness- e.g., Malignancy 9 . Pregnant or breast feeding woman