Clinical effectiveness of symptomatic therapy compared to standard step up care for the treatment of low impact psoriatic oligoarthritis: a 2 arm parallel group feasibility study. - POISE

niversity of Oxford0 sites60 target enrollmentMay 9, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Psoriatic Arthritis (PsA) is an inflammatory arthritis. PsA is a highly heterogenous disease with a proportion of participants having mild non-progressive disease. Well validated prognostic factors in PsA can identify these Participants including number of active joints, systemic inflammation levels, radiographic damage and functional ability at presentation. There is little research addressing outcomes and treatment options for mild disease.
Sponsor: niversity of Oxford
Enrollment: 60
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

May 9, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•This trial will recruit adult participants with newly diagnosed psoriatic arthritis who have not previously received treatment with synthetic or biological DMARDs for their articular disease. For this trial, only participants with mild disease defined as low disease activity and impact will be eligible (see below.
•Participants consented to the PsA inception cohort (MONITOR\-PsA) and to be approached for alternate interventional therapies.
•Participants with mild disease as defined by:
•\-Oligoarticular disease with \<5 active joints at baseline assessment.
•\-Low disease activity as defined by a PsA disease activity score (PASDAS) \=3\.2\.
•\-Low impact of disease as defined a PsA impact of disease (PSAID) \=4\.
•Participant is willing and able to give informed consent for participation in the trial.
•Male or female.
•Aged 18 years or above.
•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 if receiving DMARD therapy (excluding sulfasalazine).

•The patient may not enter the trial if ANY of the following apply:
•\=1 poor prognostic factors for psoriatic arthritis, from
•oraised C reactive protein (CRP) defined as \> 4g/dl for standard non\-hsCRP
•oradiographic damage defined as the presence of \= 1 erosion on plain radiographs of the hands and feet
•ohealth assessment questionnaire (HAQ) score \> 1
•Contraindications to non\-steroidal anti\-inflammatory drugs
•Previous treatment for articular disease with synthetic DMARDs (including methotrexate, leflunomide or sulfasalazine) or biologic DMARDs (including TNF, IL12/23 or IL17 inhibitor therapies) or targeted synthetic DMARDs (PDE4 of JAK inhibitor therapies).
•Female patient who is pregnant, breast feeding or planning pregnancy during the course of the trial.
•Significant renal or hepatic impairment.
•Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.