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临床试验/NCT01465438
NCT01465438已完成4 期

Can New Imaging- and Biomarkers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Psoriatic Arthritis Patients Receiving Adalimumab?

Glostrup University Hospital, Copenhagen1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2006年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Modified Psoriatic Arthritis Response criteria (PsARC)

研究概览

简要总结

Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, which has a estimated prevalence of 0.3 - 1 %. The clinical course varies, but PsA is often a progressive, erosive arthritis causing severe disability and increased mortality.

The biologic treatment infliximab and etanercept have recently been introduced for treatment of PsA and psoriasis, and current data indicate a higher efficacy than with previously available therapies. No clinical trials on adalimumab in PsA are yet published (2005), but preliminary data are encouraging. The improved treatment options have increased the need for sensitive methods for diagnosis, monitoring and prognostication of PsA, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Ultrasonography (US) and magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.

The hypothesis is that adalimumab will be an effective treatment option for PsA. Novel imaging- and biomarkers can provide additional information, compared to clinical measures and radiography, concerning activity, destructive progression and prediction of therapeutic response in PsA patients receiving adalimumab. The perspective is a potential improvement in diagnosis, monitoring and prognostication of patients with PsA.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject Population: patients with active PsA, fulfilling the following major criteria:
  • Diagnosis of PsA according to Moll and Wright criteria (Moll and Wright,
  • Clinical active disease, defined as >2 (of 76) swollen joints and > 2 (of 78) tender joints
  • Involvement of the hands (Clinical swelling of 1 or more finger joint and/or 1 or more 1 sausage finger)
  • Clinical indication for anti-TNF alpha therapy, according to treating physician
  • Among other issues: Age >18 years; adequate birth control; no contraindications for anti-TNF alpha-therapy, no previous anti-TNF alpha-therapy, no other significant dermatological disorders than psoriasis.

排除标准

  • 未提供

研究组 & 干预措施

Adalimumab

Experimental

Responders at week 24 continue treatment with adalimumab. Non-responders at week 24 stops treatment with adalimumab.

干预措施: Adalimumab (Drug)

结局指标

主要结局

Modified Psoriatic Arthritis Response criteria (PsARC)

时间窗: 24 weeks

次要结局

未报告次要终点

研究者

发起方
Glostrup University Hospital, Copenhagen
申办方类型
Other

研究点 (1)

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