Trial Outcomes & Findings for Psoriatic Oligoarthritis Intervention With Symptomatic thErapy (NCT NCT03797872)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

48 weeks

Results posted on

2021-05-10

Participant Flow

The POISE trial opened on 17 April 2019 in Oxford and 19 September 2019 in Bath. The study remained open until 16 July 2020 as planned.

Participant milestones

Participant milestones
Measure	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. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: 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of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Care n=1 Participants 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. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: 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). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1 Participants	0 Participants	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=1 Participants	0 Participants	1 Participants n=1 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants	0 Participants	0 Participants n=1 Participants
Sex: Female, Male Female	0 Participants n=1 Participants	0 Participants	0 Participants n=1 Participants
Sex: Female, Male Male	1 Participants n=1 Participants	0 Participants	1 Participants n=1 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	1 participants n=1 Participants	—	1 participants n=1 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: All participants included

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).

Outcome measures

Outcome measures
Measure	Standard Care n=1 Participants 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. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: 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). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg
Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study	0 Participants	—

SECONDARY outcome

Timeframe: 48 weeks

Population: Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 weeks

Population: Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 weeks

Population: Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis. The US was not performed as this was only for participants in the intervention group.

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

Outcome measures

Outcome data not reported

Adverse Events

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Local/IM Steroid Injections

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Laura Coates

University of Oxford

Phone: +447870257823

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place