Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      It is increasingly recognized that although suppression of inflammation is a treatment goal
      in rheumatoid arthritis, many people who have control of their inflammation continue to
      experience pain. A number of studies have recently shown that by measuring further
      characteristics of pain in rheumatoid arthritis, e.g. neuropathic pain, quantitative sensory
      testing, compared with objective measures of inflammation, it is possible to acquire more
      detailed information about the level of pain in relation to inflammation that a patient with
      rheumatoid arthritis is experiencing, which could assist in developing their care.

      In this study, the investigators will explore validated endpoints for pain including the
      Visual Analogue Scale for pain, neuropathic pain scores and quantitative sensory testing for
      pain.

      The investigators will evaluate in a population-based study, the pain profile using the
      Visual Analog Scale (VAS), neuropathic pain assessment, quantitative sensory testing (QST) by
      pain pressure thresholds (PPT) in comparison to markers of inflammation in order to assess
      the difference in pain outcomes between baseline pre- and post- treatment in a population of
      participants with active Rheumatoid Arthritis treated with abatacept and Tumor Necrosis
      Factor (TNF) inhibitors respectively. All measures will be conducted systematically in the
      abatacept and TNF inhibitor groups pre- and post-treatment with respective biologic agents.
      Participants with active Rheumatoid Arthritis who may be eligible for biologic treatment will
      be screened for enrolment into the study.
    

Detailed description: 
      Primary objective To examine: Pain characteristics in participants with active rheumatoid
      arthritis receiving abatacept biologic therapy versus TNF inhibitor therapy in the form of
      adalimumab.

      To establish if there are differences in pain outcomes by patient reported scores, objective
      measures of pain using quantitative sensory testing and inflammatory markers in participants
      receiving biologic therapies for rheumatoid arthritis.

      Population: The population being assessed in this study are participants with active
      rheumatoid arthritis with a disease activity score of greater than 5.1.

      Intervention: Subjects will be randomized to treatment with abatacept or adalimumab for
      active rheumatoid arthritis

      Comparison group: Abatacept is being compared to adalimumab therapy in the trial
    

Intervention name(s): Abatacept Injection; Adalimumab Injection
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomized to treatment with either abatacept or adalimumab; Subjects will be randomized to treatment with either abatacept or adalimumab
Other intervention name(s): Orencia; Humira
Intervention MeSH terms: Adalimumab; Abatacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment