A randomized clinical trial comparing the effect of methylprednisolone and dexamethasone pulse in the control of rheumatoid arthritis flare up

Objectives: The aim of this study is the comparison of the efficacy and safety of dexamethasone and methylprednisolone pulse in the management of rheumatoid arthritis flare up. Design, setting and conduct: In a randomized double blind study in Emam Reza hospital of Tabriz University of Medical Sciences, rheumatoid arthritis patients after explaining the study aims and obtaining written informed consent will recruit to the study. They will divide accidentally according to the two last number of their document to the two groups. Disease activity of all patients will be measured by the disease activity score 28 (DAS28). Participants: Rheumatoid arthritis patients which their disease diagnosed according the American college of rheumatology 2011 criteria and have severely active disease (DAS28>5.2). Exclusion criteria: Congestive heart failure; active infection; hypokalemia (K+<3.5); systolic BP>180 or diastolic BP>100; diabetes; pregnancy Intervention: A group of patients will receive methylprednisolone 1gr/d IV for 3 days and another group dexamethasone 120mg/d IV for 3 days. In both groups after pulse therapy prednisolone 15mg/d in divided doses will be started. All patients will be visited before intervention, at Fourth day (one day after intervention) and one month later. DAS 28 will be measured by a rheumatologist who doesn’t know the patients received methylprednisolone or dexamethasone. Main outcome measures: Disease activity will be measured by the DAS28. The clinical examination will be performed by a rheumatologist and DAS28 will be calculated using the numbers of swollen and tender joints, C-reactive protein (CRP) and patient general health by the patient using visual analog scale (VAS) .

Vice chancellor for research, Tabriz University of Medical Sciences