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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2008-005212-40-SE
Date of registration: 14/08/2008
Prospective Registration: Yes
Primary sponsor: Karolinska Institute
Public title: Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSING
Scientific title: Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSING
Date of first enrolment: 14/10/2008
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005212-40
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase: 
Countries of recruitment
Sweden
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
Rheumatoid arthritis: Only female patients will be included, this is because it is needed to minimize inter-individual differences in pain perception, known to be significantly dependent on gender (Soetano et al. Are there gender differences in pain perception? J Neurosci Nurse 2006;38:172-176; Garcia et al. Gender differences in pressure pain threshold in a repeated measures assessment. Psychol Health Med 2007;12:567-579). Age 20-50. Fulfilling ACR criteria for RA. The responsible Rheumatologist have found need for antirheumatic treatment with Remicade.

Healthy controls: Females. Age 20-50.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
RA: Males (se explanation under E.3). Fulfilling ACR criteria for fibromyalgia. left-handness (for fMRI). Significant heart disease. Current treatment with antidepressive drugs. Contraindications for Remicade.

Healthy controls: Males. Fulfilling ACR criteria for RA or fibromyalgia. Recurrent pain problems (>40 mm on VAS scale for pain). Left-handness (for fMRI). Significant heart disease. Current treatment with antidepressive drugs. Neurological disease. Diabetes Mellitus.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
Health Condition(s) or Problem(s) studied
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 Remicade.
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10060016 Term: Alpha tumor necrosis factor
MedDRA version: 9.1 Level: LLT Classification code 10029817 Term: Nuclear magnetic resonance imaging brain
MedDRA version: 9.1 Level: LLT Classification code 10053689 Term: Cardiovascular autonomic function test
Intervention(s)

Trade Name: Remicade
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Infliximab
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: The overall aim with this project is to investigate central pain mechanisms in RA and helathy controls, and in RA how these mechanisms are influenced by TNF-blockade with Remicade.
Primary end point(s): Not applicable as this is not a trial of a new drug and the goal is to investigate mechanisms of pain processing before and after Remicade administration. The resason for using placebo-control in the study is to minimize inter-individual differences that can greatly affect the fMRI results and make conclusions difficult.

Brief description of the protocol: RA patients with insufficient disease control on MTX will be randomized into two groups: One will receive Remicade at baseline and after 2 weeks as usual whereas the other group will receive placebo infusions at baseline and after 2 weeks. At baseline ( pat and controls) and after 4 weeks (patients only) of treatment/placebo patients and healthy controls will undergo clinical evaluation with assessment of DAS28 and other disease parameters, blood sampling, fMRI with pain stimuli in a predefined scheme, pain assessments, algometry for measurement of peripheral pain and heart rate variability for measurement of autonomic activity.

Clinical response and pain effects of Remicade will be evaluated but this is not the primary goal with the study.
Secondary Objective: To investigate effects of Remicade on peripheral pain, fatigue and autonomic function in RA
Secondary Outcome(s)
Secondary ID(s)
MR080508
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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