POISE - Psoriatic Oligoarthritis Intervention with Symptomatic thErapy

Phase 1

• 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.; MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-001085-42-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-09
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

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).
•Participant has clinically acceptable laboratory results within 6 weeks of enrolment:
oHaemoglobin count > 8.5 g/dL
oWhite blood count (WBC) > 3.5 x 109/L
oAbsolute neutrophil count (ANC) > 1.5 x 109/L
oPlatelet count> 100 x 109/L
oALT and alkaline phosphatase levels <3 x upper limit of normal
•In the Investigator’s opinion, is able and willing to comply with all trial requirements.
•Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the trial.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

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.
•Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patients at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
•Patients who have participated in another research trial involving an investigational product in the past 12 weeks.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified