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A Study to See if Adding Hydroxychloroquine to Methotrexate Helps Protect the Heart in People with Early Rheumatoid Arthritis

Cardioprotective Benefits of Methotrexate and Hydroxychloroquine Combination Therapy vs Methotrexate Monotherapy in Early and Low Risk Rheumatoid Arthritis A Randomized Control Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091917
Enrollment
66
Registered
2025-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified

Interventions

Intervention1: Methotrexate and Hydroxychloroquine Therapy: Tablet Methotrexate 7.5mg once a week for 6 months and Tablet Hydroxychloroquine 200mg twice a day daily for 6 months Control Intervention1:

Sponsors

Dr Cyrus Paul Isaac
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinically Diagnosed patients with Rheumatoid Arthritis fulfilling the EULAR Criteria more than 6 2. Early Rheumatoid Arthritis less than 2 years and Low Risk Rheumatoid Arthritis. DAS28 less than 3.2 3. Adult patients of the age of 18 to 60 years. 4. All Genders. 5. Participants willing to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant and Nursing women. 2. Patients with history of cardiovascular complications like MI, CVA and Heart Blocks and abnormal ECG changes. 3. Patients using lipid lowering drugs. 4. Patients on medications that can prolong the QT interval. 5. Patients with other autoimmune diseases. 6. Patients with hypertension and diabetes. 7. Impaired renal and liver functions. 8. Patients with joint deformities. 9. Patients with Retinal defects.

Design outcomes

Primary

MeasureTime frame
Comparing the cardioprotective benefits between the two groups.Timepoint: 1. Baseline 2. 1 Month 3. 3 Months 4. 6 Months—

Secondary

MeasureTime frame
Safety and Efficacy of drugs used in both groups.Timepoint: 1. Baseline 2. 1 Month 3. 3 Months 4. 6 Months—

Countries

India

Contacts

Public ContactDr Cyrus Paul Isaac

Shri Atal Bihari Vajpayee Medical College and Research Institute

nskarg97@gmail.com9343610550

Outcome results

None listed

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