Comparison between Methotrexate and Apremilast in psoriatic arthritis: A single blinded randomized controlled trial

o sponsor0 个研究点目标入组 31 人开始时间: 待定最近更新: 2023年7月25日

试验速览

暂无简介。

•1.Age >= 18 years.
•2.Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at time of screening.
•3.Have >= 2 swollen AND >= 2 tender joints at randomization.
•4.Consenting to participate in the study.

•1.Has received study drugs (methotrexate/apremilast) in last 3 months.
•2.Has received any biological DMARDs (TNFi, IL-12/23 inhibitor, IL-17 inhibitor, CTLA4-Ig) or, other small molecules (JAK inhibitors) ever.
•3.Recent initiation or a change in the dose of any DMARD in last 3 months prior to randomization.
•4.Oral steroid dose more than 10 mg/day of prednisolone or equivalent.
•5.Renal dysfunction (serum creatinine >1.5mg/dl)
•6.Liver function abnormality (SGOT and SGPT >2 times upper limit of normal and/or total bilirubin >2mg/dl)
•7.Presence of anaemia (haemoglobin <9gm%), leucopenia ( <3500/mm3) and thrombocytopenia ( <100000/mm3)
•8.Presence of comorbid illnesses like major psychiatric disorders, chronic liver disease, cardiac disease, respiratory illness and illicit substance abuse which will hamper the participation of the subject in the study.
•9.Pregnant or breast-feeding females.
•10.Females of child bearing potential, not willing to use contraception during study period.
•11.History of allergy to any component of the study drugs.
•12.Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV) screening test positivity.
•13.Presence of active infections, either bacterial, fungal or viral, at randomization or within the last 4 weeks prior to randomization.
•14.Evidence of active tuberculosis at randomization.
•15.Active malignancy.

发起方

o sponsor