Status:
COMPLETED
Pain Modulation in Rheumatoid Arthritis (RA) - Influence of Adalimumab
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Abbott
Swedish Foundation for Strategic Research
Conditions:
Arthritis, Rheumatoid
Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 Necro...
Detailed Description
Background Rheumatoid arthritis (RA) RA is characterized by joint inflammation causing peripheral pain, however the relation between peripheral pathology and pain intensity is weak. There is substant...
Eligibility Criteria
Inclusion
- 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(in a maximum tolerable up to 20 mg/week orally or subcutaneously), or previous treatment with methotrexate withdrawn due to documented side effects.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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2016
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01197144
Start Date
October 1 2010
End Date
November 28 2016
Last Update
October 22 2020
Active Locations (2)
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1
Dep of Rheumatology
Stockholm, Sweden, SE-171 76
2
MR Centre, Dep of Clinical Neuroscience
Stockholm, Sweden, SE-171 76