Trial · NCT02756650

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

NCT02756650, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2020-06-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement. Trials, record NCT02756650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02756650

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement
NCT number: NCT02756650
Status: Completed
Phases: Phase 2
Enrollment: 8 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Behcet Disease
Interventions: Canakinumab
First posted: 2016-04-29
Last updated: 2020-06-11
Results first posted: 2020-06-11
Limitations and caveats: This was an exploratory trial that was not powered for a statistical analysis.

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Attacks	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.
Primary	Modified Expanded Disability Status Scale (EDSS)	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.
Primary	Neuro-Behçet's Disability Score (NBDS)	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.
Primary	Modified Ranking Score (mRS)	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.
Primary	Ataxia	30 days	Number of the partcipants with ataxia. 3 participants from neurology clinic were evaluated.
Primary	Physical Examination Scores Indicating Change in Muscle Strength	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.
Primary	C-reactive Protein (CRP) Values	30 days	Mean CRP (C-reactive protein) value (8 participants)
Primary	Erythrocyte Sedimentation Rate (ESR)	30 days	Mean erythrocyte sedimentation rate (ESR) value (8 participants)
Primary	SAA (Serum Amyloid A)	30 days	Mean Serum Amyloid A value (8 participants)
Primary	Hemoptysis	30 days	The number of the participants with hemoptysis

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Attacks	30 days	Intent-to-Treat (ITT) population: all 8 subjects who took at least one dose of study medication	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Modified Expanded Disability Status Scale (EDSS)	30 days	Behçet's Disease set	scores on a scale	MEAN
PRIMARY	Neuro-Behçet's Disability Score (NBDS)	30 days	Behçet's disease set	scores on a scale	MEAN
PRIMARY	Modified Ranking Score (mRS)	30 days	Behçet's disease set	scores on a scale	MEAN
PRIMARY	Ataxia	30 days	Randomized set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Physical Examination Scores Indicating Change in Muscle Strength	30 days	Behçet's disease set	scores on a scale	MEAN
PRIMARY	C-reactive Protein (CRP) Values	30 days	randomized set	mg/L	MEAN
PRIMARY	Erythrocyte Sedimentation Rate (ESR)	30 days	randomized set	mm/H	MEAN
PRIMARY	SAA (Serum Amyloid A)	30 days	randomized set	mg/L	MEAN
PRIMARY	Hemoptysis	30 days	randomized set	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Attacks	ACZ885N		0		Participants
Modified Expanded Disability Status Scale (EDSS)	ACZ885N		1.16	Standard Deviation 2.02	scores on a scale
Neuro-Behçet's Disability Score (NBDS)	ACZ885N		0.66	Standard Deviation 1.15	scores on a scale
Modified Ranking Score (mRS)	ACZ885N		0.66	Standard Deviation 1.15	scores on a scale
Ataxia	ACZ885N		1		Participants
Physical Examination Scores Indicating Change in Muscle Strength	ACZ885N	Upper right extremity	5.0	Standard Deviation 0	scores on a scale
Physical Examination Scores Indicating Change in Muscle Strength	ACZ885N	Lower right extremity	5.0	Standard Deviation 0	scores on a scale
Physical Examination Scores Indicating Change in Muscle Strength	ACZ885N	Upper left extremity	4.7	Standard Deviation 0.57	scores on a scale
Physical Examination Scores Indicating Change in Muscle Strength	ACZ885N	Lower left extremity	5.0	Standard Deviation 0	scores on a scale
C-reactive Protein (CRP) Values	ACZ885N		14.58	Standard Deviation 20.26	mg/L

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ACZ885N	8
Overall Study	COMPLETED	ACZ885N	6
Overall Study	NOT COMPLETED	ACZ885N	2

Source ClinicalTrials.gov

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Middle ear inflammation	Ear and labyrinth disorders	ACZ885N	1	8
other	Swelling of eyelid	Eye disorders	ACZ885N	1	8
other	Abdominal pain upper	Gastrointestinal disorders	ACZ885N	1	8
other	Aphthous ulcer	Gastrointestinal disorders	ACZ885N	7	8
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	ACZ885N	1	8
other	Folliculitis	Infections and infestations	ACZ885N	3	8
other	Influenza	Infections and infestations	ACZ885N	1	8
other	Pilonidal cyst	Infections and infestations	ACZ885N	1	8
other	Rash pustular	Infections and infestations	ACZ885N	1	8
other	Rhinitis	Infections and infestations	ACZ885N	1	8

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ACZ885N	0	8
Total, other adverse events	ACZ885N	8	8
Total, serious adverse events	ACZ885N	0	8

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02756650

GET https://conductscience.org/api/trials/v1/NCT02756650/results?page=2

API reference For AI assistants