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Psoriatic Oligoarthritis Intervention With Symptomatic thErapy (POISE)

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Methotrexate

Sulfasalazine

Leflunomide

Methylprednisolone

Triamcinolone

About this trial

This is an interventional treatment trial for Psoriatic Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Oxford University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care

Local/IM steroid injections

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Psoriatic Arthritis Disease Activity Score (PASDAS)

A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as <3.2.

Ultrasound Score of Synovitis

A summary score of synovitis measured at baseline. The score will comprise of 23 joints bilaterally. Grey scale synovitis is scored at each site 0-3 and power doppler is also scored 0-3 at each site where higher scores indicate more severe disease. These scores are then summed to give a final score. Score range is 0-276

Ultrasound Score of Enthesitis

A summary score of enthesitis measured at baseline. The score will comprise of 5 entheses bilaterally. Power doppler is scored 0-3 at each site where higher scores indicate more severe disease activity. Calcifications, enthesophytes and grey scale abnormalities will each be score 0 (absent) or 1 (present) at each site. These scores are then summed to give a final score. Score range is 0-30

Full Information

NCT ID

NCT03797872

First Posted

December 18, 2018

Last Updated

May 7, 2021

Sponsor

University of Oxford

Collaborators

National Institute for Health Research, United Kingdom

1. Study Identification

Unique Protocol Identification Number

NCT03797872

Brief Title

Psoriatic Oligoarthritis Intervention With Symptomatic thErapy

Acronym

POISE

Official Title

Clinical Effectiveness of Symptomatic Therapy Compared to Standard Step up Care for the Treatment of Low Impact Psoriatic Oligoarthritis: a 2 Arm Parallel Group Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

April 17, 2019 (Actual)

Primary Completion Date

July 16, 2020 (Actual)

Study Completion Date

July 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oxford

Collaborators

National Institute for Health Research, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

Arm 1: Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard practice in these PsA clinics following current international recommendations and National requirements for the prescription of biologic therapy. Whilst physician discretion is used, most commonly Initial therapy will be with methotrexate alone (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to at the discretion of the rheumatologist. 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 usually with a TNF inhibitor as first line. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Further details are available in the PsA clinic treatment protocol which is Appendix D in the MONITOR-PsA protocol. Arm 2: Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local glucocorticoid injections to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication as indicated for individuals. Local glucocorticoid injections will include injections with methylprednisolone or triamcinolone. All active joints will be treated with glucocorticoid injections. Glucocorticoid injections can be either be given as an intra-articular injection to an inflamed joint or as an intra-muscular injection if multiple joints are involved. 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). If Participants require DMARD therapy, they will be offered rescue therapy as per usual clinical care but will be asked to continue with data collection for the trial. This is to ensure that sufficient data is collected for the trial but risks in delaying treatment to the individual are mitigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Blinded assessor will perform clinical evaluations

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard care

Arm Type

Active Comparator

Arm Description

Arm Title

Local/IM steroid injections

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Other Intervention Name(s)

methotrexate sodium

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sulfasalazine

Other Intervention Name(s)

sulfasalazine pill

Intervention Description

Sulfasalazine up to 3g daily po

Intervention Type

Drug

Intervention Name(s)

Leflunomide

Other Intervention Name(s)

leflunomide pill

Intervention Description

Leflunomide 10-20mg daily po

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Other Intervention Name(s)

methylprednisolone acetate

Intervention Description

For IA or IM injection 20-120mg

Intervention Type

Drug

Intervention Name(s)

Triamcinolone

Other Intervention Name(s)

triamcinolone acetonide

Intervention Description

For IA or IM injection 20-120mg

Primary Outcome Measure Information:

Title

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

Description

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

Psoriatic Arthritis Disease Activity Score (PASDAS)

Description

Time Frame

48 weeks

Title

Ultrasound Score of Synovitis

Description

Time Frame

0 weeks

Title

Ultrasound Score of Enthesitis

Description

Time Frame

0 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Oxford University Hospitals NHS Trust

City

Oxford

State/Province

Oxfordshire

ZIP/Postal Code

OX3 7LD

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Undecided

Citations:

PubMed Identifier

35035537

Citation

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. Erratum In: Ther Adv Musculoskelet Dis. 2022 Feb 9;14:1759720X221077827.

Results Reference

derived

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Psoriatic Oligoarthritis Intervention With Symptomatic thErapy

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