Clinical Trial: 1 Year Canakinumab Treatment in Behcet's Disease Patients With Neurologic or Vascular Involvement
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: An Open Label, Exploratory Study to Establish the Efficacy and Safety of 1 Year Canakinumab Treatment in Behcet's Disease Patients With Neurologic or Vascular Involvement
Brief Summary: Primary objective of the study is to evaluate the safety and efficacy of canakinumab on the clinical and inflammatory findings of Behced Disease patients with neurologic and vascular involvement.
Detailed Summary:
Primary endpoint: Resolution of acute exacerbation findings related to Behced Disease 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 Behced 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 will be defined as full clinical recovery to the pre-attack state, disappearance of MRI lesion(s), and normalisation of Cerebrospinal Fluid findings.
Partial response will be 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 will be defined as no improvement in clinical findings, no change on MRI, no change in cerebrospinal fluid parameters, or worsening in those findings.
For patients wi
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Resolution of attacks [ Time Frame: 30 days ]
Original Primary Outcome: Resolution of attacks [ Time Frame: 30 days ]
Current Secondary Outcome:
- Prevention of attacks [ Time Frame: once a month, through study completion, an average of one year ]the attack recurrence will be recorded by investigator.
- VAS [ Time Frame: once a month, through study completion, an average of one year ]headache will be measured by VAS
- Neuro behcet disease score [ Time Frame: once a month, through study completion, an average of one year ]A questionaire that assesses neurological findings of patients.
- VAS [ Time Frame: once a month, through study completion, an average of one yaer ]stomachache will be measured by VAS
- VAS [ Time Frame: once a month through study completion, an average of one year ]extremity pain will be measured by VAS
Original Secondary Outcome:
- Prevention of attacks [ Time Frame: once a month, through study completion, an avarage of one year ]the attack recurrence will be recorded by investigator.
- VAS [ Time Frame: once a month, through study completion, an avarage of one year ]headache will be measured by VAS
- Neuro behcet disease score [ Time Frame: once a month, through study completion, an avarage of one year ]A questionairre that assesses neurological findings of patients.
- VAS [ Time Frame: once a month, through study completion, an avarage of one yaer ]stomachache will be measured by VAS
- VAS [ Time Frame: once a month through study completion, an avarage of one year ]extremity pain will be measured by VAS
Information By: Novartis
Dates:
Date Received: March 31, 2016
Date Started: June 2016
Date Completion: April 2018
Last Updated: July 11, 2016
Last Verified: July 2016