Clinical trial NCT04177173: Methotrexate and Statins With Methotrexate Alone in the Treatment of Rheumatoid Arthritis
Official title: Comparison of Combination of Methotrexate and Statins With Methotrexate Alone as an Anti-inflammatory Agent in the Treatment of Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis, Rheumatoid
Keywords: Methotrexate
Statins
Rheumatoid Arthritis
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of drugs defined by improvement in Disease Activity Score 28 (DAS28)
timeFrame: 6 months
Secondary outcomes:
measure: Adverse Drug Reaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Mayo Hospital
state: Punjab
Study officials:
affiliation: Associate Professor
name: Rabia Rathore, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Abeles AM, Marjanovic N, Park J, Attur M, Chan ES, Al-Mussawir HE, Dave M, Fisher MC, Stuchin SA, Abramson SB, Pillinger MH. Protein isoprenylation regulates secretion of matrix metalloproteinase 1 from rheumatoid synovial fibroblasts: effects of statins and farnesyl and geranylgeranyl transferase inhibitors. Arthritis Rheum. 2007 Sep;56(9):2840-53. doi: 10.1002/art.22824.
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