NCT04177173

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: King Edward Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Simvastatin 20 mg	improvement of disease activity
DRUG	Methotrexate 10 mg	improvement of disease activity

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-12-14
• Completion: 2018-12-14
• First posted: 2019-11-26
• Last updated: 2019-11-26

Locations

1 site across 1 country: Pakistan