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

• Status: Completed
• Trial end date: 2019-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective of the study was to evaluate the safety and efficacy of canakinumab on the clinical and inflammatory findings of Behced Disease patients with neurologic and vascular involvement.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal

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