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

King Edward Medical University

Status and phase: Completed; Phase 4

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Simvastatin 20 mg; Drug: Methotrexate 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04177173

5181/REG./KEMU/2017

Details and patient eligibility

About

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.

Full description

After approval from Board of Studies and IRB of King Edward Medical University, all patients fulfilling inclusion and exclusion criteria from out patient department and wards of Mayo Hospital Lahore will be selected and randomized to group A or group B by lottery method (using coin flipping method) with one group receiving combination of methotrexate and simvastatin and other group receiving simvastatin only. All patients will be given adequate dose of analgesics for pain relief. Informed consent will be obtained from the patient. Demographic information like name, age and sex, will also be obtained. DAS 28 scoring will be done at the time of presentation and will be noted. Patients will be followed at 1 month, 3 month and at 6 month. At each follow up DAS 28(ESR) score will be calculated using DAS 28 calculator. All this information will be recorded on predesigned proforma (attached).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Simvastatin & Methotrexate

Experimental group

Description:

Methotrexate 10 mg once a week per oral for 6 months and Statins (Simvastatin) 20 mg once a day per oral

Treatment:

Drug: Simvastatin 20 mg

Drug: Methotrexate 10 mg

Methotrexate

Active Comparator group

Description:

Methotrexate 10 mg once a week for 6 months

Treatment:

Drug: Methotrexate 10 mg