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Psoriatic Oligoarthritis Intervention With Symptomatic thErapy

NCT03797872 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-05-10

Study results available
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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

Conditions

Interventions

DRUG

Methotrexate

Methotrexate up to 25mg/week as tolerated po or sc

DRUG

Sulfasalazine

Sulfasalazine up to 3g daily po

DRUG

Leflunomide

Leflunomide 10-20mg daily po

DRUG

Methylprednisolone

For IA or IM injection 20-120mg

DRUG

Triamcinolone

For IA or IM injection 20-120mg

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2020-07-16
Completion
2020-07-16

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03797872 on ClinicalTrials.gov