Psoriatic Oligoarthritis Intervention With Symptomatic thErapy

• Status: Completed
• Trial end date: 2020-07-16
• Target enrollment: 0
• Participant gender: All

Summary

POISE is a two arm interventional trial nested within a cohort (Trials Within Cohorts or TWiCs design). This tests less aggressive early therapy in patients newly diagnosed with low impact oligoarticular PsA. Arm 1 will receive standard step up therapy in the cohort and act as the control group. Arm 2 will receive local steroid injections to active joints and will be able to use non-steroidal anti-inflammatory drugs (NSAIDs) only

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborator: National Institute for Health Research, United Kingdom
• Treatments: Leflunomide; Methotrexate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Sulfasalazine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• 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 (defined as true abstinence, oral contraceptives, implants, intrauterine device, barrier method with spermicide, or surgical sterilization) 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:

• Haemoglobin count > 8.5 g/dL

• White blood count (WBC) > 3.5 x 109/L

• Absolute neutrophil count (ANC) > 1.5 x 109/L

• Platelet count > 100 x 109/L

• ALT 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.

Exclusion Criteria:

• ≥1 poor prognostic factors for psoriatic arthritis, from

• raised C reactive protein (CRP) defined as > 4g/dl for standard non-hsCRP

• radiographic damage defined as the presence of ≥ 1 erosion on plain radiographs of the hands and feet

• health 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.