1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement (Behcet)
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|ClinicalTrials.gov Identifier: NCT02756650|
Recruitment Status : Completed
First Posted : April 29, 2016
Results First Posted : June 11, 2020
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Behcet Disease||Drug: Canakinumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Exploratory Study to Establish the Efficacy and Safety of 1 Year Canakinumab Treatment in Behçet's Disease Patients With Neurologic or Vascular Involvement|
|Actual Study Start Date :||June 23, 2016|
|Actual Primary Completion Date :||January 31, 2019|
|Actual Study Completion Date :||January 31, 2019|
Canakinumab was administered monthly
150 mg or 300 mg of canakinumab was administered monthly. IV (SC after month 6)
Other Name: ACZ885
- Number of Participants With Attacks [ Time Frame: 30 days ]
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.
- Modified Expanded Disability Status Scale (EDSS) [ Time Frame: 30 days ]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) [ Time Frame: 30 days ]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.
- Modified Ranking Score (mRS) [ Time Frame: 30 days ]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.
- Ataxia [ Time Frame: 30 days ]Number of the partcipants with ataxia. 3 participants from neurology clinic were evaluated.
- Physical Examination Scores Indicating Change in Muscle Strength [ Time Frame: 30 days ]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.
- C-reactive Protein (CRP) Values [ Time Frame: 30 days ]Mean CRP (C-reactive protein) value (8 participants)
- Erythrocyte Sedimentation Rate (ESR) [ Time Frame: 30 days ]Mean erythrocyte sedimentation rate (ESR) value (8 participants)
- SAA (Serum Amyloid A) [ Time Frame: 30 days ]Mean Serum Amyloid A value (8 participants)
- Hemoptysis [ Time Frame: 30 days ]The number of the participants with hemoptysis
- Visual Analogue Scores (VAS) for Headache [ Time Frame: 30 days ]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.
- Visual Analogue Scores (VAS) for Stomachache [ Time Frame: 30 days ]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.
- Visual Analogue Scores (VAS) for Extremity Assessments [ Time Frame: 30 days ]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.
- Visual Analogue Scores (VAS) for Patients' General Assessments [ Time Frame: 30 days ]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 Global Assessment [ Time Frame: 30 days ]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
- Steroid Dose Regimen [ Time Frame: 30 days ]Mean steroid treatment dose (8 participants)
- BDCAF (Behçet's Disease Current Activity Form) [ Time Frame: 30 days ]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.
- Extremity (Localized) Pain Assessment (VAS) [ Time Frame: 30 days ]Localized pain in the extremities were assessed by visual analogue scale scores ranging between Scale; 0 is the best outcome; 10 is worst.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756650
|Novartis Investigative Site|
|Istanbul, Turkey, 34093|
|Study Chair:||Ahmet Gül, Prof||IU Faculty of Medicine|
|Principal Investigator:||Murat Kurtuncu, Ass.Prof||IU Faculty of Medicine|
|Principal Investigator:||Gulsen Akman Demir, Prof||Bilim University Faculty of Medicine|