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

Phase 1

• Conditions: Rheumatoid arthritis (RA)The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and in RA how these are influenced by autonomic neural regulation and TNF-blockade with Humira.

• Registration Number: EUCTR2009-017163-42-SE
• Lead Sponsor: Karolinska Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-23
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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(abatacept, rituximab or tocilizumab) is allowed (=40 patients in the whole study).TNF-blockers should have been withdrawn 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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified