ISRCTN70603700进行中（未招募）4 期
Clinical effectiveness of standard step up care (methotrexate) compared to early combination DMARD therapy with standard step up care compared to early use of TNF inhibitors with standard step up care for the treatment of moderate to Severe Psoriatic arthritis: a 3-arm parallel group randomised controlled trial.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 315
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participant is willing and able to give informed consent for participation in the trial.
- •2. Male or Female, aged 18 years or above.
- •3. Participants consented to the PsA inception cohort (MONITOR-PsA REC Ref 17/SC/0556) and to be approached for alternate interventional therapies.
- •4. Poor prognostic factors at baseline. Either:
- •4.1 Polyarticular disease with > = 5 active joints at baseline assessment OR
- •4.2 Oligoarticular disease with < 5 active joints at baseline but with one or more of the following poor prognostic factors: raised C reactive protein, radiographic damage, health assessment questionnaire> 1
- •5. 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 (or 2 years if received leflunomide unless treated with washout therapy) as in standard practice.
- •6. Participant has clinically acceptable laboratory results within 28 days of baseline:
- •6.1 Haemoglobin count > 8.5 g/dL
- •6.2 White blood count (WBC) > 3.5 x 109/L
- •6.3 Absolute neutrophil count (ANC) > 1.5 x 109/L
- •6.4 Platelet count> 100 x 109/L
- •6.5 AST or ALT and alkaline phosphatase levels < 3 x upper limit of normal
- •7. In the Investigator’s opinion, is able and willing to comply with all trial requirements.
- •8. Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the trial.
排除标准
- •1. Previous treatment for articular disease with disease modifying drugs (DMARDs) including, but not limited to, methotrexate, sulfasalazine, leflunomide and ciclosporin
- •2. Female patient who is pregnant, breast-feeding or planning pregnancy during the course of the trial.
- •3. Significant renal or hepatic impairment.
- •4. Patients who test positive for Hepatitis B, C or HIV.
- •5. Contraindication to any of the investigative drugs.
- •6. Currently abuse drugs or alcohol
- •7. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- •8. Life expectancy of less than 6 months.
- •9. Any other significant disease or disorder which, in the opinion of the Investigator, may either put patients at risk because of participation in the trial, or may influence the result of the trial, or their ability to participate in the trial.
- •10. Participation in another research trial involving an investigational product in the past 12 weeks.
- •11. Additional exclusion criteria apply to patients randomised to arm 3 and receiving adalimumab therapy:
- •11.1 Active tuberculosis (TB), chronic viral infections, recent serious bacterial infections, those receiving live vaccinations within 3 months of the anticipated first dose of study medication, or those with chronic illnesses that would, in the opinion of the investigator, put the participant at risk.
- •11.2 Latent TB unless they have received appropriate anti-tuberculous treatment as per local guidelines
- •11.3 History of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ.
研究者
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