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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02756650
Recruitment Status : Completed
First Posted : April 29, 2016
Results First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
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 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


Arm Intervention/treatment
Experimental: Canakinumab
Canakinumab was administered monthly
Drug: Canakinumab
150 mg or 300 mg of canakinumab was administered monthly. IV (SC after month 6)
Other Name: ACZ885




Primary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.

  5. Ataxia [ Time Frame: 30 days ]
    Number of the partcipants with ataxia. 3 participants from neurology clinic were evaluated.

  6. 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.

  7. C-reactive Protein (CRP) Values [ Time Frame: 30 days ]
    Mean CRP (C-reactive protein) value (8 participants)

  8. Erythrocyte Sedimentation Rate (ESR) [ Time Frame: 30 days ]
    Mean erythrocyte sedimentation rate (ESR) value (8 participants)

  9. SAA (Serum Amyloid A) [ Time Frame: 30 days ]
    Mean Serum Amyloid A value (8 participants)

  10. Hemoptysis [ Time Frame: 30 days ]
    The number of the participants with hemoptysis

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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

  16. Steroid Dose Regimen [ Time Frame: 30 days ]
    Mean steroid treatment dose (8 participants)

  17. 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.

  18. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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

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


Locations
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Turkey
Novartis Investigative Site
Istanbul, Turkey, 34093
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02756650    
Other Study ID Numbers: CACZ885NTR01
First Posted: April 29, 2016    Key Record Dates
Results First Posted: June 11, 2020
Last Update Posted: June 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The publication has been planned for Q4 2020.
Access Criteria: Access from peer reviewed journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Behcet Disease
Inflammation
Immune system
Arthritis
Additional relevant MeSH terms:
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Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular