Clinical effectiveness of standard step up care (methotrexate) compared to early combination DMARD therapy with standard step up care compared to early use of TNF inhibitors with standard step up care for the treatment of moderate to Severe Psoriatic arthritis: a 3-arm parallel group randomised controlled trial. - SPEED

niversity of Oxford0 个研究点目标入组 315 人2018年7月2日

概览

暂无简介。

注册库

who.int

开始日期

2018年7月2日

结束日期

待定

最后更新

6年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•Participant is willing and able to give informed consent for participation in the trial.
•Male or Female, aged 18 years or above.
•Participants consented to the PsA inception cohort (MONITOR\-PsA REC Ref 17/SC/0556\) and to be approached for alternate interventional therapies.
•Poor prognostic factors at baseline. Either
•oPolyarticular disease with \=5 active joints at baseline assessment OR
•oOligoarticular disease with \<5 active joints at baseline but with one or more of the following poor prognostic factors: raised C reactive protein, radiographic damage, health assessment questionnaire\>1
•Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter (or 2 years if received leflunomide unless treated with washout therapy) as in standard practice.
•Participant has clinically acceptable laboratory results within 28 days of baseline:
•oHaemoglobin count \> 8\.5 g/dL
•oWhite blood count (WBC) \> 3\.5 x 109/L

•Previous treatment for articular disease with disease modifying drugs (DMARDs) including, but not limited to, methotrexate, sulfasalazine, leflunomide and ciclosporin
•Female patient who is pregnant, breast\-feeding or planning pregnancy during the course of the trial.
•Significant renal or hepatic impairment.
•Patients who test positive for Hepatitis B, C or HIV.
•Contraindication to any of the investigative drugs.
•Patients who currently abuse drugs or alcohol
•Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
•Patient with life expectancy of less than 6 months.
•Any other significant disease or disorder which, in the opinion of the Investigator, may either put patients at risk because of participation in the trial, or may influence the result of the trial, or their ability to participate in the trial.
•Participation in another research trial involving an investigational product in the past 12 weeks.