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

Phase 4

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Simvastatin 20 mg; Drug: Methotrexate 10 mg

• Registration Number: NCT04177173
• Lead Sponsor: King Edward Medical University

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-12-14
• Study Completion: 2018-12-14
• Study First Submitted: 2019-04-07
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-25
• Study First Posted: 2019-11-26
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Efficacy of drugs defined by improvement in Disease Activity Score 28 (DAS28)	6 months	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

Secondary Outcome Measures

Name	Time	Method
Adverse Drug Reaction	6 months	Adverse event reported against any of the intervention under study

Trial Locations

Locations (1)

Mayo Hospital; 🇵🇰 Lahore, Punjab, Pakistan