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.

niversity of Oxford0 sites315 target enrollmentApril 26, 2019

Overview

No summary available.

Registry

who.int

Start Date

April 26, 2019

End Date

February 28, 2025

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Participant is willing and able to give informed consent for participation in the trial.
•2\. Male or Female, aged 18 years or above.
•3\. Participants consented to the PsA inception cohort (MONITOR\-PsA REC Ref 17/SC/0556\) and to be approached for alternate interventional therapies.
•4\. Poor prognostic factors at baseline. Either:
•4\.1 Polyarticular disease with \> \= 5 active joints at baseline assessment OR
•4\.2 Oligoarticular 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
•5\. 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.
•6\. Participant has clinically acceptable laboratory results within 28 days of baseline:
•6\.1 Haemoglobin count \> 8\.5 g/dL
•6\.2 White blood count (WBC) \> 3\.5 x 109/L

•1\. Previous treatment for articular disease with disease modifying drugs (DMARDs) including, but not limited to, methotrexate, sulfasalazine, leflunomide and ciclosporin
•2\. Female patient who is pregnant, breast\-feeding or planning pregnancy during the course of the trial.
•3\. Significant renal or hepatic impairment.
•4\. Patients who test positive for Hepatitis B, C or HIV.
•5\. Contraindication to any of the investigative drugs.
•6\. Currently abuse drugs or alcohol
•7\. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
•8\. Life expectancy of less than 6 months.
•9\. 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.
•10\. Participation in another research trial involving an investigational product in the past 12 weeks.