Pain Clinical Trial
— PARADEOfficial title:
Pain Modulation in RA - Influence of Adalimumab. A Randomized, Placebo-controlled Study Using Functional Magnetic Resonance Imaging (PARADE)
Verified date | October 2020 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to obtain increased knowledge concerning central pain and fatigue processing in rheumatoid arthritis, and how these conditions are influenced by treatment with Tumor Necrosis Factor (TNF) blockade with adalimumab.
Status | Completed |
Enrollment | 70 |
Est. completion date | November 28, 2016 |
Est. primary completion date | November 28, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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(in a maximum tolerable up to 20 mg/week orally or subcutaneously), or previous treatment with methotrexate withdrawn due to documented side effects.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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Dep of Rheumatology | Stockholm | |
Sweden | MR Centre, Dep of Clinical Neuroscience | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Abbott, Swedish Foundation for Strategic Research, The Swedish Research Council |
Sweden,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain processing as measured by Blood Oxygen Level Dependent (BOLD) patterns in functional Magnetic Resonance Imaging (fMRI) of the brain | The main purpose of the study is to investigate effects of treatment/placebo on central nervous pain processing, measured with fMRI. | 4 weeks | |
Secondary | Fatigue Visual Analogue Scale (VAS) | The treatment effects on Fatigue VAS will be measured and related to fMRI data. | 4 weeks |
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