Psoriatic Arthritis (PsA) is an inflammatory arthritis. PsA is a highly heterogenous disease with a proportion of participants having mild non-progressive disease. Well validated prognostic factors in PsA can identify these Participants including number of active joints, systemic inflammation levels, radiographic damage and functional ability at presentation. There is little research addressing outcomes and treatment options for mild disease. MedDRA version: 20.0
Conditions
Interventions
Trade Name: Methylprednisolone acetate BP
Product Name: Methylprednisolone acetate BP
Pharmaceutical Form: Injection
INN or Proposed INN: Methylpredniso
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This trial will recruit adult participants with newly diagnosed psoriatic arthritis who have not previously received treatment with synthetic or biological DMARDs for their articular disease. For this trial, only participants with mild disease defined as low disease activity and impact will be eligible (see below. •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 8.5 g/dL o White blood count (WBC) > 3.5 x 109/L o Absolute neutrophil count (ANC) > 1.5 x 109/L o Platelet count > 100 x 109/L o ALT and alkaline phosphatase levels =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: The patient may not enter the trial if ANY of the following apply: • =1 poor prognostic factors for psoriatic arthritis, from o raised C reactive protein (CRP) defined as > 4g/dl for standard non-hsCRP o radiographic damage defined as the presence of = 1 erosion on plain radiographs of the hands and feet o 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the feasibility of conducting of a future definitive trial to establish whether a subgroup of participants with mild PsA can be safely and effectively managed without DMARDs. The study will assess: 1. The proportion of participants referred to the PsA clinic who meet the inclusion criteria (with this mild disease phenotype as defined by oligoathritis, no poor prognostic factors and PSAID =4) 2. The proportion of participants willing to consent to the study indicating that they find the intervention acceptable 3. The proportion of participants not offered DMARD therapy during the 48 week trial period (DMARD therapy will be offered if participants have active disease despite 2 doses of glucocorticoids within a 6 month period) ;Secondary Objective: To develop the design of a future definitive trial to establish whether a subgroup of patients with mild PsA can be safely and effectively managed without DMARDs. ; Primary end point(s): This study is a feasibility study and the primary outcome is to establish the feasibility of a future study addressing this treatment option. Specific feasibility analyses include the calculation of the proportions of: • eligible patients in the cohort over the recruitment period for POISE • eligible patients consenting into the POISE trial • patients/participants requiring escalation to DMARD therapy within the first 48 weeks. ;Timepoint(s) of evaluation of this end point: This will be evaluated at the end of the feasibility study after 48 weeks participation in the trial. Eligible patients and proportion consenting will be monitored thoughout. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcome in this study is to investigate the PASDAS response and changes in PASDAS score occurring in the patients within this small feasibility study. The primary outcome of the future study will be the proportion of Participants achieving a good response level (reduction from baseline of >1.6 and final score of <3.2) in the PsA Disease Activity Score (PASDAS)[2]. Descriptive data on PASDAS will be collected to allow accurate sample size estimations for any future trial. ;Timepoint(s) of evaluation of this end point: This will be evaluated through the data collected at all of the follow-up visits. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Trials and Research Govern
University of Oxford
Outcome results
None listed