1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement
Condition: Behcet Disease
MeSH terms: Behcet Syndrome
Intervention: Canakinumab
Intervention description: 150 mg or 300 mg of canakinumab was administered monthly. IV (SC after month 6)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Behcet Disease; Inflammation; Immune system; Arthritis

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.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients aged over 18-60 Behced Disease fulfilling the International Study Group (ISG)
        criteria, who have a recent exacerbation of large-vessel vascular disease and/or
        parenchymal neurologic disease For Neurologic Involvement

          -  Patients experiencing an acute exacerbation of parenchymal neurologic disease
             involving brainstem and/or diencephalic region.

          -  Exacerbation is defined based on the presence of both of the following:

          -  An acute/subacute neurological syndrome including any of hemiparesis, ataxia,
             dysarthria,headache within the first month of onset of neurologic manifestations
             (without any prior high dose steroid treatment)

          -  Compatible cranial MRI lesion involving brainstem and/or diencephalic region

        For Vascular Disease :

        Patients experiencing an acute exacerbation of vascular disease within the last month,
        involving

          -  Large arteries (abdominal aorta, pulmonary arteries, extremity arteries)

          -  Large veins (deep vein thrombosis of extremities, caval vein thrombosis, dural sinus
             thrombosis)

          -  Compatible radiological findings (spiral CT, MR, or Doppler ultrasonography)

        Exclusion Criteria:

        For Neurologic Involvement :

          -  Presence of severe neurological sequelae from any previous attacks rendering the
             patient dependent on others physically or mentally

          -  Any other neurological cause underlying the picture including ischemic central nervous
             system lesion on MRI

          -  Any previous treatment with biological agents other than interferon-alpha or any
             previous treatment with cyclophosphamide

          -  No interferon in the last 6 months, no Intra Venous Metilprednizolon in the past month

        For Vascular disease and general :

          -  Presence of severe vascular sequelae from any previous attacks rendering the patient
             dependent on others

          -  Any other vascular disease complication the evaluation of exacerbation

          -  Any previous treatment with biological agents other than interferon alpha, or any
             previous treatment with cyclophosphamide

          -  No interferon alpha in the last 6 months, no IVMP in the past month

          -  History of Squamo Cell Carcinoma OR Basal Cell Carcinoma in previous 5 years. General

          -  Presence or history of any other inflammatory rheumatic disease

          -  Positive Purified Protein Derivative test (according to local guidance) where an
             active Tuberculosis infection cannot be excluded via Quantiferon (T-Spot or
             radiographic imaging if needed) Pregnancy or lactation

          -  Presence of any active or chronic infection or any major episode of infection
             requiring hospitalization or treatment with i.v. antibiotics within 30 days or oral
             antibiotics within 14 days prior to screening

          -  History or a malignancy within the last 5 years, except for successfully excised
             squamous or basal cell carcinoma of the skin

          -  Women of childbearing potential not using the contraception method(s) specified in
             this study, as well as women who are breastfeeding

          -  With known sensitivity to canakinumab

          -  Use of any other investigational agent in the last 30 days