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

Randomised controlled trial to determine the efficacy of darbepoetin in improving haemoglobin in patients of rheumatoid arthritis with anaemia of chronic disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050776

Enrollment

112

Registered

2023-03-17

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M056- Rheumatoid arthritis with involvement of other organs and systems

Interventions

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 Interv

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >18 yrs. 2. RA (defined by EULAR criteria 2010) 3. Anaemia of chronic disease as defined by 4. Haemoglobin 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

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

Design outcomes

Primary

Measure	Time frame
Difference in haemoglobin in the study group at the end of study periodTimepoint: 12 weeks	—

Secondary

Measure	Time frame
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 – 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	—

Measure

Time frame

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 – 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

—

Countries

India

Contacts

Public ContactAbhishek Kumar

Army Hospital (Research and Referral)

mishrak20@gmail.com9871323179

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026