A clinical trial to study the effect of a drug (Darbepoetin), on haemoglobin in patients with anaemia of chronic disease due to rheumatoid arthritis

INTERVENTION: Intervention1: Darbepoetin with standard of care: Injection darbepoetin will be given subcutaneously at the doses of 50 ‐100 micrograms every 15 days for total of three months duration. Control Intervention1: standard of care: for rheumatoid arthritis as per disease activity status and American College of Rheumatology Guideline 2021 CONDITION: Health Condition 1: M056‐ Rheumatoid arthritis with involvement of other organs and systems PRIMARY OUTCOME: Difference in haemoglobin in the study group at the end of study periodTimepoint: 12 weeks SECONDARY OUTCOME: to estimate the effect of darbepoetin on disease related outcomes (like swollen joint count (SJC), tender joint count (TJC), patient global assessment of disease (PGA) and disease activity as measured by Disease Activity Score 28 Joints â?? c‐Reactive Protein (DAS28‐CRP)Timepoint: baseline, 4 weeks, 8 weeks and 12 weeks to estimate the effect of darbepoetin on quality of life as measured by Short Form‐36 (SF‐36) Health Survey Questionnaire.Timepoint: baseline and 12 weeks to estimate the safety of darbepoetin in patients with rheumatoid arthritisTimepoint: baseline, 4 weeks, 8 weeks and 12 weeks INCLUSION CRITERIA: 1. Age >18 yrs. 2. RA (defined by EULAR criteria 2010) 3. Anaemia of chronic disease as defined by 4. Haemoglobin <13g/dl in males and <12 g/dl in females 5. Normocytic normochromic or microcytic hypochromic RBCs on peripheral blood smear (PBS) 6. Normal or high serum ferritin ( >50 ng/L) 7. Low/normal TIBC 8. Normal or low transferrin saturation