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1 Year Canakinumab Treatment in Behcet's Disease Patients With Neurologic or Vascular Involvement (Behcet)

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ClinicalTrials.gov Identifier: NCT02756650
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Behcet Disease Drug: drug administration Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 23, 2016
Estimated Primary Completion Date : June 23, 2018
Estimated Study Completion Date : June 23, 2018


Arms and Interventions

Arm Intervention/treatment
Experimental: "Canakinumab"."Ilaris®"
Patients will take canakinumab monthly
Drug: drug administration
monthly canakinumab will be administered
Other Name: "Canakinumab"."Ilaris®"


Outcome Measures

Primary Outcome Measures :
  1. Resolution of attacks [ Time Frame: 30 days ]
    the attacks will be assessed by pyhsician global assesment,


Secondary Outcome Measures :
  1. Prevention of attacks [ Time Frame: once a month, through study completion, an average of one year ]
    the attack recurrence will be recorded by investigator.

  2. VAS [ Time Frame: once a month, through study completion, an average of one year ]
    headache will be measured by VAS

  3. 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.

  4. VAS [ Time Frame: once a month, through study completion, an average of one yaer ]
    stomachache will be measured by VAS

  5. VAS [ Time Frame: once a month through study completion, an average of one year ]
    extremity pain will be measured by VAS


Other Outcome Measures:
  1. decrease of steroid usage [ Time Frame: 12 months ]
    beginning dosage of steroid will be decreased due to response of patient


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Turkey
Novartis Investigative Site Recruiting
Istanbul, Turkey, 34093
Novartis Investigative Site Recruiting
Mecidiyekoy/Istanbul, Turkey, 34394
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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
More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02756650     History of Changes
Other Study ID Numbers: CACZ885NTR01
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Behcet Disease
Inflammation
Immune system
Arthritis

Additional relevant MeSH terms:
Vasculitis
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs