Pain modulation in RA – Influence of adalimumab. A randomized, placebo-controlled study using functional magnetic resonance imaging - PARADE

Karolinska Institute0 个研究点开始时间: 2010年3月23日最近更新: 2017年5月22日

适应症

试验速览

暂无简介。

•RA patients: Age =18 , Fulfilling ACR criteria for RA, Disease duration = 10 years.
•The responsible Rheumatologist has found need for antirheumatic treatment with Humira.
•Patients should not have have had treatment with adalimumab before. However, use of maximum one previous TNF-blocker (infliximab, etanercept, golimumab or certolizumab) and/or one other biologic treatment (abatacept, rituximab or tocilizumab) is allowed (=40 patients in the whole study).TNF-blockers should have been withdrawn > 2 months before study entry. The latest administration of abatacept or tocilizumab should have been given > 2 months prior to study entry. The latest administration of rituximab should have been given > 3 months prior to study entry.
•Healthy controls: Healthy volunteers, age =18.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•RA patients: Fulfilling ACR criteria for fibromyalgia. For fMRI – left handedness and all forms of metallic implants. Severe ischemic heart disease. Concurrent treatment with antidepressant drugs.
•Contraindication to adalimumab.
•Healthy controls (group C): Fulfilling ACR criteria for fibromyalgia. For fMRI – left handedness and all forms of metallic implants. Severe ischemic heart disease. Concurrent treatment with antidepressant drugs. Concurrent neurological disease.

发起方

Karolinska Institute