Overview

Pain Modulation in Rheumatoid Arthritis (RA) - Influence of Adalimumab

Status:
Completed
Trial end date:
2016-11-28
Target enrollment:
0
Participant gender:
All
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 Necrosis Factor (TNF) blockade with adalimumab.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Karolinska Institutet
Collaborators:
Abbott
Swedish Foundation for Strategic Research
The Swedish Research Council
Treatments:
Adalimumab
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orally or subcutaneously), or previous treatment with methotrexate withdrawn due to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.