Pain Modulation in Rheumatoid Arthritis (RA) - Influence of Adalimumab (PARADE)
Arthritis, Rheumatoid, Pain, Fatigue
About this trial
This is an interventional basic science trial for Arthritis, Rheumatoid focused on measuring TNF, functional Magnetic Resonance Imaging, Autonomic, Vagus, adalimumab
Eligibility Criteria
Inclusion Criteria:
- Age ≥18
- Fulfilling American College of Rheumatology (ACR) criteria for RA.
- Disease duration ≤ 5 years.
- Either under treatment with methotrexate (in a maximum tolerable up to 20 mg/week orally or subcutaneously), or previous treatment with methotrexate withdrawn due to documented side effects.
- Patients should be bio-naïve.
- Disease activity: Disease Activity Score (DAS28)>3.2 and Swollen joint count (SJC)>1 and Tender Joint Count (TJC)>1.
Exclusion Criteria:
For fMRI - left handedness and all forms of metallic implants.
- Fulfilling ACR criteria for fibromyalgia.
- Severe ischemic heart disease.
- Concurrent treatment for depression/anxiety with antidepressant drugs.
- Contraindication to adalimumab.
- Active or latent tuberculosis.
- Chronic infections including hepatitis B or C.
- Malignancy, multiple sclerosis, Systemic lupus erythematosus.
- Other reason as evaluated by the PI.
Sites / Locations
- Dep of Rheumatology
- MR Centre, Dep of Clinical Neuroscience
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Placebo Comparator
No Intervention
Adalimumab
Placebo
Healthy Controls
Treatment with adalimumab 40 mg sc eow for 4 weeks
Treatment with placebo s c eow for 4 weeks
Healthy volunteers, age ≥18. Will perform all the same pain assessments, blood sampling and baseline fMRI as RA patients Exclusion criteria: For fMRI - left handedness and all forms of metallic implants. Fulfilling ACR criteria for fibromyalgia. Severe ischemic heart disease. Concurrent treatment for depression/anxiety with antidepressant drugs. Concurrent neurological disease. Other reason as evaluated by the P.I.