EUCTR2018-001085-42-GB进行中（未招募）1 期
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. - POISE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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 <5 active joints at baseline assessment.
- •-Low disease activity as defined by a PsA disease activity score (PASDAS) =3.2.
- •-Low impact of disease as defined a PsA impact of disease (PSAID) =4.
- •Participant is willing and able to give informed consent for participation in the trial.
- •Male or female.
- •Aged 18 years or above.
- •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).
- •Participant has clinically acceptable laboratory results within 6 weeks of enrolment:
- •oHaemoglobin count > 8.5 g/dL
- •oWhite blood count (WBC) > 3.5 x 109/L
- •oAbsolute neutrophil count (ANC) > 1.5 x 109/L
- •oPlatelet count> 100 x 109/L
- •oALT and alkaline phosphatase levels <3 x upper limit of normal
- •In the Investigator’s opinion, is able and willing to comply with all trial requirements.
- •Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •The patient may not enter the trial if ANY of the following apply:
- •=1 poor prognostic factors for psoriatic arthritis, from
- •oraised C reactive protein (CRP) defined as > 4g/dl for standard non-hsCRP
- •oradiographic damage defined as the presence of = 1 erosion on plain radiographs of the hands and feet
- •ohealth 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.
研究者
相似试验
已完成
不适用
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 drugsPsoriatic oligoarthritisMusculoskeletal DiseasesISRCTN16739990niversity of Oxford1
已完成
不适用
Therapeutic Efficacy Ratio and Symptom Improvement Effect of New Potassium Ion-Competitive Acid Blocker (P-CAB)JPRN-UMIN000018455Ishihara Gastroenterology clinic20
已完成
Unknown
Clinical Observation of the Therapeutic Efficacy of Fuzi Lizhong Decoction Combined with SOX Regimen Chemotherapy in Treating Advanced Gastric Cancer with Spleen-Stomach Deficiency-Cold SyndromeGastric CancerITMCTR2024000164Yichang Traditional Chinese Medicine Hospital
尚未招募
2 期
A Comparative study on cauterization and internal medicine Arumuga Chenduram in management of OsteoarthritisCTRI/2019/05/019141Ayothidoss Pandithar hospital
招募中
Unknown
Clinical Emotional Freedom Technique for Vision Impairment and Psychological Issues: A randomised online trialVision ImpairmentMental Health - Studies of normal psychology, cognitive function and behaviourNeurological - Other neurological disordersACTRN12624000779572Bond University100