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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02756650
• Date of registration: 31/03/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: 1 Year of Treatment With Canakinumab in Behçet's Disease Patients With Neurologic or Vascular Involvement Behcet
• Scientific 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
• Date of first enrolment: June 23, 2016
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02756650
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Turkey

Contacts

• Name: Murat Kurtuncu, Ass.Prof
• Affiliation: IU Faculty of Medicine

• Name: Ahmet Gül, Prof
• Affiliation: IU Faculty of Medicine

• Name: Gulsen Akman Demir, Prof
• Affiliation: Bilim University Faculty of Medicine

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Behcet Disease

Intervention(s)

Drug: Canakinumab

Primary Outcome(s)

Visual Analogue Scores (VAS) for Extremity Assessments [Time Frame: 30 days]

Extremity (Localized) Pain Assessment (VAS) [Time Frame: 30 days]

Modified Ranking Score (mRS) [Time Frame: 30 days]

Visual Analogue Scores (VAS) for Stomachache [Time Frame: 30 days]

Physician's Global Assessment [Time Frame: 30 days]

Number of Participants With Attacks [Time Frame: 30 days]

SAA (Serum Amyloid A) [Time Frame: 30 days]

Ataxia [Time Frame: 30 days]

BDCAF (Behçet's Disease Current Activity Form) [Time Frame: 30 days]

C-reactive Protein (CRP) Values [Time Frame: 30 days]

Hemoptysis [Time Frame: 30 days]

Erythrocyte Sedimentation Rate (ESR) [Time Frame: 30 days]

Neuro-Behçet's Disability Score (NBDS) [Time Frame: 30 days]

Modified Expanded Disability Status Scale (EDSS) [Time Frame: 30 days]

Physical Examination Scores Indicating Change in Muscle Strength [Time Frame: 30 days]

Steroid Dose Regimen [Time Frame: 30 days]

Visual Analogue Scores (VAS) for Headache [Time Frame: 30 days]

Visual Analogue Scores (VAS) for Patients' General Assessments [Time Frame: 30 days]

Secondary ID(s)

CACZ885NTR01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02756650