Psoriatic Oligoarthritis Intervention With Symptomatic thErapy

NCT ID: NCT03797872

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-17
• Study Completion Date: 2020-07-16

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.

Conditions

Psoriatic Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard care

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.

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

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

Sulfasalazine

Intervention Type: DRUG

Sulfasalazine up to 3g daily po

Leflunomide

Intervention Type: DRUG

Leflunomide 10-20mg daily po

Local/IM steroid injections

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).

Group Type: EXPERIMENTAL

Methylprednisolone

Intervention Type: DRUG

For IA or IM injection 20-120mg

Triamcinolone

Intervention Type: DRUG

For IA or IM injection 20-120mg

Interventions

Methotrexate

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

Intervention Type: DRUG

Sulfasalazine

Sulfasalazine up to 3g daily po

Intervention Type: DRUG

Leflunomide

Leflunomide 10-20mg daily po

Intervention Type: DRUG

Methylprednisolone

For IA or IM injection 20-120mg

Intervention Type: DRUG

Triamcinolone

For IA or IM injection 20-120mg

Intervention Type: DRUG

Other Intervention Names

methotrexate sodium; sulfasalazine pill; leflunomide pill; methylprednisolone acetate; triamcinolone acetonide

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35035537 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18/SC/0261

Identifier Type: -

Identifier Source: org_study_id