Humira in Rheumatoid Arthritis - Do Bone Erosions Heal?
Condition: Rheumatoid Arthritis; Arthritis; Joint Diseases
MeSH terms: Arthritis; Arthritis, Rheumatoid; Joint Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Studies on tumor necrosis factor alpha antagonist (anti-TNF) therapy in rheumatoid arthritis
      (RA) patients have found that erosive damage may "heal" in some RA patients treated with
      anti-TNF. Repeated examinations of adalimumab (Humira) treated RA patients, using computed
      tomography (CT), magnetic resonance imaging (MRI), ultrasonography (US) and radiography will
      allow detailed assessment of the extent of bone repair/healing during adalimumab (Humira)
      therapy.
    

Detailed description: 
      Studies on tumor necrosis factor alpha antagonist (anti-TNF) therapy in rheumatoid arthritis
      (RA) patients have found that radiographic erosions scores decreased in some patients. This
      suggests that erosive damage may "heal" in some RA patients treated with anti-TNF. However,
      it is not clarified whether the reduced scores are caused by technical issues as observer
      variation and image acquisition differences. Furthermore, radiography of erosions is a 2D
      representation of a 3D pathology and therefore not ideal for visualizing healing, if present.
      Verification of erosion healing under anti-TNF therapy with adalimumab (Humira) by optimal
      imaging methods, would markedly influence our perception of the effect and potential of
      adalimumab (Humira) for modifying structural joint damage in RA. Magnetic Resonance Imaging
      (MRI), allowing high-resolution 3D visualization of bone damage as well as the inflammatory
      activity in the bone (bone marrow edema/osteitis), is more sensitive for visualization of
      bone erosions than radiography. Computed Tomography (CT) is a 3D radiographic imaging
      technique, which is not suited for assessment of inflammation, but can be considered a
      reference method for assessment of bone damage, due to its direct 3D visualization of
      calcified tissue. Internationally recommended MRI scoring systems as well as methods for
      estimation of erosion volumes have been developed, with participation by our research group.
      Ultrasonography (US), even though less validated, is more sensitive than radiography and
      comparable to MRI in detecting bone erosions in RA joints. Additionally, US provides
      visualisation of soft tissue changes and synovitis, using gray-scale and Doppler US.

      Repeated MRI, CT, US and radiographic examinations of RA joints with mild to moderate
      radiographic damage under adalimumab (Humira) therapy will allow detailed assessment of the
      extent of bone repair/healing during adalimumab (Humira) therapy.
    

Intervention name(s): Adalimumab (Humira)
Intervention type(s): Drug
Intervention description(s): Adalimumab (Humira) 40 mg subcutaneously every other week
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Computed tomography; Magnetic resonance imaging; Radiography; Tumor necrosis factor alpha antagonists