A feasibility study to test how effective is it to treat patients with mild psoriatic arthritis using only local steroid injections without being put onto more powerful arthritis drugs

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: The trial is a randomised open‐label feasibility trial with two arms: 1. Standard care 2. Symptomatic therapy The trial forms part of a “Trials within Cohortsâ€? or TWiCs design where participants in the cohort may be offered interventional studies subject to meeting the relevant inclusion/exclusion criteria. Consent is requested in the cohort study for data to be used without further approach. This is a randomised open‐label feasibility trial assessing the acceptability of conservative management in mild PsA and the feasibility of a future definitive trial within a cohort in a “Trials within Cohortsâ€? or TWiCs design. A maximum of 60 participants will be recruited (30 to the cohort, arm 1 as controls and 30, arm 2 receiving the intervention). The number is an estimate, as at present it is not known how many participants with mild disease will be eligible and willing to participate. It is estimated that around 15% of participants referred with new PsA may be eligible. Each participant will be followed for 48 weeks within this trial and will then revert to standard care within the cohort. Patients in this study will attend for study visits at baseline and weeks 12, 24, 36 and 48. Patients in the intervention arm will also be able to attend for joint injections as required in between these visits via a trial helpline. At all visits, patients will be assessed clinically for disease activity and will be asked to complete patient‐reported outcomes. Adverse event information will be sought at each visit and recorded, assessed and reported as required by the protocol. Data will be entered into an electronic CRF and appropriate validation checks carried out. Data will be analysed in accord with a statistical analysis plan starting with the null hypothesis that there is no difference in the proportion of participants achieving a PASDAS good response at week 24 be CONDITION: Psoriatic oligoarthritis ; Musculoskeletal Diseases SECONDARY OUTCOME: To help plan a future definitive study, if this feasibility study is successful, the researchers will collect data on the response to treatment as measured using the Psoriatic Arthritis Disease Activity Score (PASDAS) which is calculated from clinical assessments (disease activity visual analogue scale, swollen and tender joint counts, Leeds enthesitis index) and patient‐reported items on questionnaires (SF‐36) at 0, 12, 24, 36 and 48 weeks. PRIMARY OUTCOME: ; The feasibility of conducting 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 oligoarthritis, 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); INCLUSION CRITERIA: 1. Participants consented to the PsA inception cohort (MONITOR‐PsA) and to be approached for alternate interventional therapies. 2. Participants with mild disease as defined by: 2.1 Oligoarticular disease with < 5 active joints at baseline assessment. 2.2 Low disease activity as defined by a PsA disease activity score (PASDAS) < = 3.2. 2.3 Low impact of disease as defined a PsA impact of disease (PSAID) < = 4. 3. Participant is willing and able to give informed consent for participation in the trial. 4. Male or female. 5. Aged 18 years or above. 6. 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 during the trial and for 3 months thereafter if receiving D
Epistemonikos ID: 24d4d0401078cdf560d75df4e19cdce177ebbf43
First added on: Aug 24, 2024