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

Sponsor
Karolinska Institutet
Study ID
NCT01197144
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — DRUG
    Subcutaneous, 40 mg every other week for 4 weeks
  • Placebo — DRUG
    Subcutaneous, every other week for 4 weeks

Study Details

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.

Key Dates

Start date
Oct 31, 2010
Status verified
Oct 2020
Primary completion
Nov 28, 2016
Completion
Nov 28, 2016

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Adalimumab
    Treatment with adalimumab 40 mg sc eow for 4 weeks
  • Placebo Comparator: Placebo
    Treatment with placebo s c eow for 4 weeks
  • No Intervention: Healthy Controls
    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.

Primary Outcome Measure

Pain processing as measured by Blood Oxygen Level Dependent (BOLD) patterns in functional Magnetic Resonance Imaging (fMRI) of the brain [ Time Frame: 4 weeks ]

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