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

Primary Purpose

Arthritis, Rheumatoid

Status

Completed

Phase

Phase 4

Locations

Pakistan

Study Type

Interventional

Intervention

Simvastatin 20 mg

Methotrexate 10 mg

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Methotrexate, Statins, Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simvastatin & Methotrexate

Methotrexate

Arm Description

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

Methotrexate 10 mg once a week for 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse Drug Reaction

Adverse event reported against any of the intervention under study

Full Information

NCT ID

NCT04177173

First Posted

April 7, 2019

Last Updated

November 25, 2019

Sponsor

King Edward Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04177173

Brief Title

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

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

December 14, 2018 (Actual)

Study Completion Date

December 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Edward Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

Keywords

Methotrexate, Statins, Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simvastatin & Methotrexate

Arm Type

Experimental

Arm Description

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

Arm Title

Methotrexate

Arm Type

Active Comparator

Arm Description

Methotrexate 10 mg once a week for 6 months

Intervention Type

Drug

Intervention Name(s)

Simvastatin 20 mg

Intervention Description

improvement of disease activity

Intervention Type

Drug

Intervention Name(s)

Methotrexate 10 mg

Intervention Description

improvement of disease activity

Primary Outcome Measure Information:

Title

Efficacy of drugs defined by improvement in Disease Activity Score 28 (DAS28)

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Adverse Drug Reaction

Description

Adverse event reported against any of the intervention under study

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rabia Rathore, FCPS

Organizational Affiliation

Associate Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Hospital

City

Lahore

State/Province

Punjab

ZIP/Postal Code

54000

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21375157

Citation

Alam SM, Kidwai AA, Jafri SR, Qureshi BM, Sami A, Qureshi HH, Mirza H. Epidemiology of rheumatoid arthritis in a tertiary care unit, Karachi, Pakistan. J Pak Med Assoc. 2011 Feb;61(2):123-6.

Results Reference

background

PubMed Identifier

18490431

Citation

Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, Aletaha D, van Riel PL. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009 Jun;68(6):954-60. doi: 10.1136/ard.2007.084459. Epub 2008 May 19.

Results Reference

result

PubMed Identifier

27437268

Citation

Mowla K, Rajai E, Ghorbani A, Dargahi-Malamir M, Bahadoram M, Mohammadi S. Effect of Atorvastatin on the Disease Activity and Severity of Rheumatoid Arthritis: Double-Blind Randomized Controlled Trial. J Clin Diagn Res. 2016 May;10(5):OC32-6. doi: 10.7860/JCDR/2016/16538.7814. Epub 2016 May 1.

Results Reference

result

PubMed Identifier

26729950

Citation

Das S, Mohanty M, Padhan P. Outcome of rheumatoid arthritis following adjunct statin therapy. Indian J Pharmacol. 2015 Nov-Dec;47(6):605-9. doi: 10.4103/0253-7613.169585.

Results Reference

result

PubMed Identifier

21093076

Citation

Aoki C, Nakano A, Tanaka S, Yanagi K, Ohta S, Jojima T, Kasai K, Takekawa H, Hirata K, Hattori Y. Fluvastatin upregulates endothelial nitric oxide synthase activity via enhancement of its phosphorylation and expression and via an increase in tetrahydrobiopterin in vascular endothelial cells. Int J Cardiol. 2012 Apr 5;156(1):55-61. doi: 10.1016/j.ijcard.2010.10.029. Epub 2010 Nov 18.

Results Reference

result

PubMed Identifier

17763406

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. Erratum In: Arthritis Rheum. 2007 Oct;56(10):3510. Al-Mussawir, Hayfez [corrected to Al-Mussawir, Hayf E].

Results Reference

result

PubMed Identifier

18078616

Citation

Lazzerini PE, Lorenzini S, Selvi E, Capecchi PL, Chindamo D, Bisogno S, Ghittoni R, Natale MR, Caporali F, Giuntini S, Marcolongo R, Galeazzi M, Laghi-Pasini F. Simvastatin inhibits cytokine production and nuclear factor-kB activation in interleukin 1beta-stimulated synoviocytes from rheumatoid arthritis patients. Clin Exp Rheumatol. 2007 Sep-Oct;25(5):696-700.

Results Reference

result

PubMed Identifier

22106090

Citation

Gazzerro P, Proto MC, Gangemi G, Malfitano AM, Ciaglia E, Pisanti S, Santoro A, Laezza C, Bifulco M. Pharmacological actions of statins: a critical appraisal in the management of cancer. Pharmacol Rev. 2012 Jan;64(1):102-46. doi: 10.1124/pr.111.004994. Epub 2011 Nov 21.

Results Reference

result

PubMed Identifier

16572283

Citation

Agrawal S, Misra R, Aggarwal A. Autoantibodies in rheumatoid arthritis: association with severity of disease in established RA. Clin Rheumatol. 2007 Feb;26(2):201-4. doi: 10.1007/s10067-006-0275-5. Epub 2006 Mar 30.

Results Reference

result

PubMed Identifier

22150039

Citation

McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011 Dec 8;365(23):2205-19. doi: 10.1056/NEJMra1004965. No abstract available.

Results Reference

result

PubMed Identifier

23289081

Citation

Dowman B, Campbell RM, Zgaga L, Adeloye D, Chan KY. Estimating the burden of rheumatoid arthritis in Africa: A systematic analysis. J Glob Health. 2012 Dec;2(2):020406. doi: 10.7189/jogh.02.020406.

Results Reference

result

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

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