Phase 4
Completed N=1
Psoriatic Oligoarthritis Intervention With Symptomatic thErapy
Source: ClinicalTrials.gov NCT03797872 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study — 0 Participants
◆ Published Evidence
Emerging
2citations · ~0 / year
Clinical effectiveness of symptomatic therapy compared with standard step-up care for the treatment of low-impact psoriatic oligoarthritis: the two-arm parallel group randomised POISE feasibility study.
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
Linked Publications
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Clinical effectiveness of symptomatic therapy compared with standard step-up care for the treatment of low-impact psoriatic oligoarthritis: the two-arm parallel group randomised POISE feasibility study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study |
— | — |
| SECONDARY Psoriatic Arthritis Disease Activity Score (PASDAS) |
— | — |
| SECONDARY Ultrasound Score of Synovitis |
— | — |
| SECONDARY Ultrasound Score of Enthesitis |
— | — |
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 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 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.
Data sourced from ClinicalTrials.gov (NCT03797872) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.