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
- Conditions
- Psoriatic oligoarthritisMusculoskeletal Diseases
- Registration Number
- ISRCTN16739990
- Lead Sponsor
- niversity of Oxford
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35035537/ (added 14/02/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1
Current inclusion criteria as of 02/03/2021:
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
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 DMARD therapy (excluding sulfasalazine)
7. Participant has clinically acceptable laboratory results within 6 weeks of enrolment:
7.1 Haemoglobin count >8.5 g/dL
7.2 White blood count (WBC) >3.5 x 10^9/L
7.3 Absolute neutrophil count (ANC) >1.5 x 10^9/L
7.4 Platelet count >100 x 10^9/L
7.5 ALT and alkaline phosphatase levels <3 x upper limit of normal
7.6 eGFR
7.7 In the Investigator’s opinion, is able and willing to comply with all trial requirements
7.8 Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the trial
_____
Previous 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 DMARD therapy (excluding sulfasalazine).
7. Participant has clinically acceptable laboratory results within 6 weeks of enrolment:
7.1 Haemoglobin count >8.5 g/dL
7.2 White blood count (WBC) >3.5 x 10^9/L
7.3 Absolute neutrophil count (ANC) >1.5 x 10^9/L
7.4 Platelet count>100 x 10^9/L
7.5 ALT and alkaline phosphatase levels <3 x upper limit of normal
7.6 In the Investigator’s opinion, is able and willing to comply with all trial requirements.
7.7 Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the trial.
1. >=1 poor prognostic factors for psoriatic arthritis, from:
1.1 Raised C reactive protein (CRP) defined as >4g/dl for standard non-hsCRP
1.2 Radiographic damage defined as the presence of >= 1 erosion on plain radiographs of the hands and feet
1.3 Health assessment questionnaire (HAQ) score >1
2. Contraindications to non-steroidal anti-inflammatory drugs
3. 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).
4. Female patient who is pregnant, breast feeding or planning pregnancy during the course of the trial.
5. Significant renal or hepatic impairment.
6. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
7. 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.
8. Patients who have participated in another research trial involving an investigational product in the past 12 weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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.<br> The study will assess:<br> 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)<br> 2. The proportion of participants willing to consent to the study indicating that they find the intervention acceptable<br> 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)<br>
- Secondary Outcome Measures
Name Time Method 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.