Psoriatic Oligoarthritis Intervention With Symptomatic thErapy

NCT03797872 | Completed Phase 4 Results DMC

• 1 other identifier: 18/SC/0261
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study

  To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48).

  48 weeks

Secondary Outcomes (3)

• Psoriatic Arthritis Disease Activity Score (PASDAS)

  48 weeks

• Ultrasound Score of Synovitis

  0 weeks

• Ultrasound Score of Enthesitis

  0 weeks

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.

Drug: Methotrexate; Drug: Sulfasalazine; Drug: Leflunomide

Local/IM steroid injections

EXPERIMENTAL

Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).

Drug: Methylprednisolone; Drug: Triamcinolone

Interventions

Methotrexate DRUG

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

Also known as: methotrexate sodium

Standard care

Sulfasalazine DRUG

Sulfasalazine up to 3g daily po

Also known as: sulfasalazine pill

Standard care

Leflunomide DRUG

Leflunomide 10-20mg daily po

Also known as: leflunomide pill

Standard care

Methylprednisolone DRUG

For IA or IM injection 20-120mg

Also known as: methylprednisolone acetate

Local/IM steroid injections

Triamcinolone DRUG

For IA or IM injection 20-120mg

Also known as: triamcinolone acetonide

Local/IM steroid injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ≥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.

Sponsors & Collaborators

• University of Oxford: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 7LD, United Kingdom

Location

Related Publications (1)

• Rombach I, Tucker L, Tillett W, Jadon D, Watson M, Francis A, Sinomati Y, Dutton SJ, Coates LC. 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. Ther Adv Musculoskelet Dis. 2022 Jan 10;13:1759720X211057668. doi: 10.1177/1759720X211057668. eCollection 2021.

  PMID: 35035537 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Methotrexate; Sulfasalazine; Leflunomide; Methylprednisolone; Methylprednisolone Acetate; Triamcinolone; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

Only 1 participants was eligible and participated in the trial during the recruitment period and this patient was lost to follow up after the baseline visit.

Results Point of Contact

• Title: Professor Laura Coates
• Organization: University of Oxford

laura.coates@ndorms.ox.ac.uk

+447870257823

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessor will perform clinical evaluations
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: January 9, 2019
• Study Start: April 17, 2019
• Primary Completion: July 16, 2020
• Study Completion: July 16, 2020
• Last Updated: May 10, 2021
• Results First Posted: May 10, 2021

Record last verified: 2020-03

Locations

GB (1)