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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-12-14

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.

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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).

Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simvastatin & Methotrexate

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

Group Type EXPERIMENTAL