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 reso
Conditions
Interventions
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
Pharma
Sponsors
Karolinska Institute
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Secondary Objective: To investigate effects of Remicade on peripheral pain, fatigue and autonomic function in RA;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. | — |
Countries
Sweden
Outcome results
None listed