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Study to evaluate the role of blood cells in tracking disease activity and treatment response in people with Rheumatoid Arthritis

Evaluating the Systemic Immune-Inflammation Index as a marker for disease activity and treatment response in Rheumatoid Arthritis - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/088551
Enrollment
95
Registered
2025-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: M05- Rheumatoid arthritis with rheumatoid factor Health Condition 2: M06- Other rheumatoid arthritis

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Dr Shreya Menon
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with Rheumatoid Arthritis (RA) based on the 2010 ACR/EULAR classification criteria, either as inpatients or outpatients, will be recruited for the study. 2. Age greater than or equal to 18 years. 3. Either treatment naive or patients who have not been adequately treated with csDMARDs (conventional synthetic Disease Modifying Antirheumatic Drugs) and tsDMARDs (targeted synthetic Disease Modifying Antirheumatic Drugs), as well as those who have discontinued treatment or have poor adherence. 4. Willing to participate and provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have received adequate dose of csDMARDs and tsDMARDs in the last 1 month. 2. Patients on steroids (10 mg/day of prednisolone or equivalent) in the past 4 weeks before enrollment. 3. Patients with iron deficiency anemia or thrombocytopenia 4. Patients with active infections such as tuberculosis or chronic viral hepatitis 5. Patients with concurrent autoimmune or inflammatory diseases such as lupus, psoriatic arthritis or inflammatory bowel disease. 6. Patients with a history of malignancy. 7. Pregnant or breast feeding women 8. Patients with severe renal or hepatic impairment (eGFR less than 30ml per minute per 1.73 metre square or liver enzymes greater than 3 times the upper limit of normal)

Design outcomes

Primary

MeasureTime frame
To evaluate the Systemic Immune-Inflammation Index (SII) as a biomarker for disease activity and treatment response in newly diagnosed Rheumatoid Arthritis (RA) patients over a 12 month periodTimepoint: At 3 months, 6 months and 12 months

Secondary

MeasureTime frame
To assess the correlation between SII and established disease activity indices - Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI), in newly diagnosed RA patientsTimepoint: At 3 months, 6 months and 12 months;To determine the ability of SII to predict changes in disease activity following initiation of therapy over a 12 month follow up.Timepoint: At 3 months, 6 months and 12 months

Countries

India

Contacts

Public ContactDr Chandrashekar UK

Kasturba Medical College, Manipal

shekar.uk@manipal.edu9845163448

Outcome results

None listed

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