This study aims at evaluating the therapeutic effects of Cilostazol as adjuvant therapies to low dose of Methotrexate in patients with Rheumatoid Arthritis and to evaluate their impact on Cyclic adenosine monophosphate(CAMP), Heme Oxygenase-1(HO-1).
Rheumatoid arthritis (RA) is characterized by the presence of hyperplastic synovium in association with immune-mediated inflammatory synovitis associated with chronic production of proinflammatory cytokines, which lead to cartilage and bone degradation .This study is a randomized, controlled double blind placebo-controlled ,prospective study to evaluate the potential therapeutic effects of Cilostazol on synovial inflammation when administered as add-on treatments to the low dose of Methotrexate. A total of 70 RA patients with active disease will be recruited from Outpatient Clinic of Physical Medicine, Rheumatology and Rehabilitation at Mansoura University hospitals, Mansoura, Egypt will be included in the study. They will be diagnosed with RA according to the American College of Rheumatology/European League Against Rheumatism criteria 2010 (the ACR/EULAR 2010 criteria). RA Patients who will meet the inclusion criteria will be enrolled in the study. They will be classified into two groups: Group 1: 35 RA patients who will receive Methotrexate and placebo for 12 weeks and serve as the control group. Group 2: 35 RA patients who will receive Methotrexate and Cilostazol 50 mg twice daily for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
Cilostazol 50 MG
Methotrexate (MTX) is the first-line therapy for treatment of RA patients. MTX suppresses proliferation of synovial fibroblasts, modulates cytokine synthesis and superoxide anion production, and inhibits neutrophil chemotaxis.
Placebo
Faculty of medicine
Al Mansurah, Egypt
RECRUITINGchange in DAS-28 CRP score
Clinical assessment by calculating of 28-joint count Disease Activity score (DAS-28) using C-reactive protein according to calculating formula(DAS28 (CRP) = 0.56\*√(Tender joint count28) +0.28\*√(Sowallen joint count28)+0.36\*ln (CRP+1)\*1.10+1.15 will done where high disease activity ≥ 5.1, low disease activity ≤ 3.2, and remission \< 2.6.
Time frame: Baseline,12 weeks
Change in Multi Dimensional Health Assessment score
Functional assessment will be assessed through Multi Dimensional Health Assessment score that include 14 items Health Assessment Questionaire .The score of the HAQ Questionnaire is calculated from the mean of the sum of the responses of the items where each item is scored from 0-3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. in addition, MDHAQ includes the assessment of morning stiffness (MS) duration in minutes.
Time frame: Baseline,12weeks
Change in Visual analog scale for pain
Visual analog scales which ranges from 0 to 10,it is a psychometric scale that is generally used in hospitals and clinics by doctors to conduct pain scale surveys to understand varying degrees of pain or discomfort experienced by a patient.
Time frame: Baseline,12 weeks
Change in the serum level of the assessed biological marker C-reactive protein
C-reactive protein :CRP value (normal range \<1.0 mg/dl). If the value is increased, the disease activity worsened. If the value is reduced the disease activity is improved.
Time frame: Baseline,12weeks
Change in the serum level of the assessed biological marker Nuclear factor kabba-B p65
Transcriptional factor involved intracellular responses to stimuli and stress .So If the value is increased, the disease activity worsened. If the value is reduced the disease activity is improved.
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Time frame: Baseline,12weeks
Change in the serum level of the assessed biological marker Hemeoxygenase-1
Hemeoxygenase-1 .
Time frame: Baseline,12weeks
Change in the serum level of the assessed biological marker Cyclic adenosine monophosphate
Cyclic adenosine monophosphate level.
Time frame: Baseline,12weeks