ISRCTN16739990已完成未知
Clinical effectiveness of symptomatic therapy compared to standard step-up care for the treatment of low impact psoriatic oligoarthritis: a 2 arm parallel group feasibility study.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 1
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35035537/ (added 14/02/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •7.7 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.
排除标准
- •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.
研究者
相似试验
进行中（未招募）
1 期
POISE - Psoriatic Oligoarthritis Intervention with Symptomatic thErapyPsoriatic 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 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859EUCTR2018-001085-42-GBniversity of Oxford60
已完成
不适用
Clinical effectiveness and side effects of different treatment methods for lung cancerCancerISRCTN14796973Fujian Provincial Hospital103
已完成
不适用
Efficacy of a combined acne treatmentSkin and Connective Tissue DiseasesAcneISRCTN18390621Complife Italia Srl80
已完成
不适用
Effectiveness of psychotherapy in patients with medically unexplained physical symptomsMedically unexplained physical symptoms (MUPS)Signs and SymptomsISRCTN13532466Faculty of Social Studies, Masaryk University444
已完成
不适用
Clozapine in the treatment of borderline personality disorder. The CALMED study.Borderline personality disorderISRCTN18352058Imperial College of Science, Technology and Medicine29