Trial Outcomes & Findings for 1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement (NCT NCT02756650)

8 subjects enrolled 5 subjects were evaluated in Rheumatology clinic. 3 subjects were evaluated in Neurology clinic.

Ten patients were planned to be enrolled. Nine patients were screened. Eight patients were enrolled. Six patients completed the study. One patient was dropped out in the 7th visit because of an unknown drug abuse. One patient was dropped out in the 11th visit because of adverse event, worsening in pulmonary artery aneurysm.

1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement

Resolution of acute exacerbation findings related to Behçet's Disease (BD). The attacks were assessed by pyhsician global assesment. 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 This was an exploratory trial that was not powered for a statistical analysis.

The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. Scale range is between 0-10 with 10 being most disability. Mean score of 3 participants who were evaluated in Neurology clinic. Other 5 participants were not evaluated for EDSS.

Neuro-Behçet's disability score (NBDS) has been proposed for parenchymal-NBD patients to quantify disabilities. This comprises scores for motor and cognitive status. NBDS is the arithmetic sum of both scores and ranges from 0 to 8, with 8 being death due to NBD. 3 neurologic participants were evaluated.

Mean Modified Rankin Scale (mRS): mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scores range from 0-5 with 5 being the worst outcome. Only 3 participants from neurology clinic were evaluated with this scale.

Number of the partcipants with ataxia. 3 participants from neurology clinic were evaluated.

All 4 extremties were evaluated for muscle strength (upper right, upper left, lower right and lower left) fro each patient. Score 0 is the worst outcome whereas 5 is the best outcome for muscle strength. 3 participants from neurology clinic were assessed.

Mean CRP (C-reactive protein) value (8 participants)

Mean erythrocyte sedimentation rate (ESR) value (8 participants)

Mean Serum Amyloid A value (8 participants)

The number of the participants with hemoptysis

Headache intensity was measured by VAS where score 0 means "no pain," and score 10 means "the worst pain''. Physician and participant determined the VAS score separately.

Stomacheache intensity was measured by VAS where score 0 means "no pain," and score 10 means "the worst pain''. VAS is determined separately by physician and the participants.

Extremity assessments were measured by VAS where score 0 means "no pain," and score 10 means "the worst possible pain''. The physicians and participants evaluated VAS separately.

Participants assessed their own well-being with VAS (visual analogue scale). Score 0 means the best outcome, score 10 is the worst outcome.

Physician's General Assessments is VAS scale, ranging between 0-5, showing the disease status of participants. Score 0 is the worst outcome; 5 is the best outcome

Mean steroid treatment dose (8 participants)

BDCAF is an assessment that is made by physician for evaluating the disease activity in last four weeks. Score range is 0 to 12, 0 is the best outcome, 12 is the worst outcome.

Localized pain in the extremities were assessed by visual analogue scale scores ranging between Scale; 0 is the best outcome; 10 is worst.