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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Comparison of Combination of Methotrexate and Statins With Methotrexate Alone as an Anti-inflammatory Agent in the Treatment of Rheumatoid Arthritis.

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: Simvastatin 20 mg
* Drug: Methotrexate 10 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvastatin & Methotrexate<br>Methotrexate 10 mg once a week per oral for 6 months and Statins (Simvastatin) 20 mg once a day per oral | Drug: Simvastatin 20 mg<br>* improvement of disease activity<br>Drug: Methotrexate 10 mg<br>* improvement of disease activity<br>|
| Active Comparator: Methotrexate<br>Methotrexate 10 mg once a week for 6 months | Drug: Methotrexate 10 mg<br>* improvement of disease activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of drugs defined by improvement in Disease Activity Score 28 (DAS28) | In Rheumatoid arthritis, DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS 28 below the value of 2.6 is interpreted as Remission/improvement | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Drug Reaction | Adverse event reported against any of the intervention under study | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methotrexate, Statins, Rheumatoid Arthritis