Methotrexate and Statins With Methotrexate Alone in the Treatment of Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2018-12-14
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to compare the efficacy of combination of Methotrexate and Statins with Methotrexate alone in the treatment of Rheumatoid Arthritis. It is hypothesized that adding statins to methotrexate for treatment of rheumatic arthritis will significantly suppress the disease activity as compared to methotrexate alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Edward Medical University
• Treatments: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Methotrexate; Simvastatin

Criteria

Inclusion Criteria:

• All patients between ages 18 years and above

• Gender- Both male and female

• Fulfilling 2010 ACR/EULAR criteria of Rheumatoid arthritis with active inflammatory disease defined by DAS 28 score >2.6,

• Normal serum cholesterol level.

Exclusion Criteria:

• Already diagnosed patients of Diabetes mellitus.

• Use of steroids greater than 4 weeks of duration or intra articular steroid injection within 4 weeks of study.

• Statin therapy in last three months.

• Statin intolerant patient.

• Elevated Creatinine Phosphokinase more than twice the upper limit of normal range.

• Diagnosed case of Chronic liver disease or abnormal liver functions (transaminases > 2 times the upper limit of normal range) before the start of treatment or during follow-up.

• High serum Creatinine level

• Pregnancy and breast feeding.