Psoriatic Oligoarthritis Intervention With Symptomatic thErapy
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Methotrexate; Sulfasalazine; Leflunomide; Methylprednisolone; Triamcinolone
Intervention description: Methotrexate up to 25mg/week as tolerated po or sc; Sulfasalazine up to 3g daily po; Leflunomide 10-20mg daily po; For IA or IM injection 20-120mg; For IA or IM injection 20-120mg
Intervention MeSH terms: Sulfasalazine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Methotrexate; Triamcinolone diacetate; Leflunomide; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Blinded assessor will perform clinical evaluations
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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
    

Eligibility 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.