1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement
Condition: Behcet Disease
MeSH terms: Behcet Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective of the study was to evaluate the safety and efficacy of canakinumab on the
      clinical and inflammatory findings of Behced Disease patients with neurologic and vascular
      involvement.
    

Detailed description: 
      Primary endpoint: Resolution of acute exacerbation findings related to Behçet's Disease (BD)
      based on achievements in any of the following items without deterioration on day 30:

      For patients with parenchymal neurologic disease: Resolution of acute exacerbation of
      parenchymal neurologic findings based on improvements in any of the following items without
      deterioration on Day 30:

        -  Improvement of muscle strength, ataxia, or other relevant neurologic findings depending
           on the involved region on neurological examination (by Neuro-Behçet's Disease Score,
           Modified Expanded Disability Status Scale, and Modified Rankin Scores) cerebrospinal
           fluid

        -  Improvement in systemic inflammatory findings (CRP, Erythrocyte Sedimentation Rate ,
           SAA)

        -  Any decrease in the size of the MRI lesion, or disappearance of contrast enhancement

        -  Improvement in patients' and physicians global assessment using a 10-cm visual analogue
           scale (VAS)

      Complete response was defined as full clinical recovery to the pre-attack state,
      disappearance of MRI lesion(s), and normalisation of Cerebrospinal Fluid findings.

      Partial response was defined as partial improvement in clinical findings, but with findings
      still worse than the pre-attack state, and MRI lesions, which become smaller with no or less
      enhancement, and a decrease in cerebrospinal fluid cell count.

      Non-response was defined as no improvement in clinical findings, no change on MRI, no change
      in cerebrospinal fluid parameters, or worsening in those findings.

      For patients with large vessel vascular disease: Resolution of acute vascular exacerbation
      findings related to Behçet's Disease based on achievements in any of the following items
      without deterioration at 1 month:

        -  Improvement in relevant symptoms (localised pain, abdominal pain, calf thickness,
           haemoptysis) by using physician and patient's global assessment with VAS

        -  Improvement in systemic inflammatory findings (CRP, ESR, SAA)

        -  Any improvement in radiological findings depending on the involved vessels (MR, CT or
           Doppler findings)

        -  Improvement in patients' and physicians global assessment using a 10-cm visual analogue
           scale (VAS)

      Complete response was defined as clinical and laboratory improvement based on ≥50%
      improvements in patient's and physician's global assessments by using VAS, and ≥50% reduction
      in CRP values; along with stable or ≥20% reduced aneurysm size in patients with arterial
      involvement, and stable or ≥20% reduced calf swelling in patients with lower extremity venous
      thrombosis.

      Partial response was defined as clinical and laboratory improvement based on observations of
      an improvement between 20-49% according to patient's and physician's global assessments by
      using VAS, 20-49% reduction in CRP values; along with stable or less than 20% reduced
      aneurysm size in patients with arterial involvement, and stable or less than 20% reduced calf
      swelling in patients with lower extremity thrombosis.

      Non-response will be defined as observing no or less than 20% clinical improvement by
      patient's and physician's global VAS or worsening of clinical findings, no change or increase
      in acute phase response, increase in aneurysm size for patients with arterial involvement or
      progression of venous thrombosis in patients with venous involvement.
    

Intervention name(s): Canakinumab
Intervention type(s): Drug
Intervention description(s): 150 mg or 300 mg of canakinumab was administered monthly. IV (SC after month 6)
Other intervention name(s): ACZ885
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behcet Disease; Inflammation; Immune system; Arthritis