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

Phase 3

Completed

Conditions: Rheumatoid arthritis with involvement of other organs and systems,

Brief Summary: | |

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|All patientswill undergo baseline clinical and laboratory evaluation. The baseline historywas recorded to include features as enumerated in 2010 ACR/EULAR classificationcriteria for rheumatoid arthritis.

Studydesign: This is a randomized 2-arm, open-label, phase 3 study. Subjects will berandomized with equal allocation to receive either (1) standard treatment forRA or (2) standard treatment for RA plus fortnightly darbepoetin. Randomizationwill be performed using computer based algorithm. Standard RA treatment will bedecided by the treating rheumatologist as per the extant guidelines.

Forsubjects in the darbepoetin arm, injection darbepoetin will be givensubcutaneously at the doses of 50 -100 mg. It will be given at theinclusion and thereafter every 15-day for total of three months duration.In the other arm standard treatment for RA as decided by the clinician will beadministered. At all visits patient will undergo assessments to see the effecton level of haemoglobin, RA disease activity as measured by DAS-28 CRP score,and quality of life assessment as measured by SF-36 health survey questionnairedisease activity of RA. Patients will also undergo assessment to detect anyadverse effect of darbepoetin and DMARDs.

Recruitment & Eligibility

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.

Exclusion Criteria

1.Concomitant additional factor contributing to anaemia like iron or vitamin deficiency, haemolysis etc.
2.Hypertension 3.Chronic organ failure (kidney, heart, liver, lung) 4.History of thromboembolism 5.Splenomegaly 6.Pregnancy and lactation.

Primary Outcome Measures

Name	Time	Method
Difference in haemoglobin in the study group at the end of study period	12 weeks

Secondary Outcome Measures

Name	Time	Method
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)	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.	baseline and 12 weeks
to estimate the safety of darbepoetin in patients with rheumatoid arthritis	baseline, 4 weeks, 8 weeks and 12 weeks

Locations (1): Army Hospital (Research & Referral)
🇮🇳
West, DELHI, India
Army Hospital (Research & Referral)
🇮🇳West, DELHI, India
Abhishek Kumar
Principal investigator
8800664015
cymarose@gmail.com