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

NCT02756650 | Completed Phase 2 Results

• 1 other identifier: CACZ885NTR01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Behcet Disease

Keywords

Behcet Disease; Inflammation; Immune system; Arthritis

Outcome Measures

Primary Outcomes (18)

• Number of Participants With Attacks

  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.

  30 days

• Modified Expanded Disability Status Scale (EDSS)

  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.

  30 days

• Neuro-Behçet's Disability Score (NBDS)

  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.

  30 days

• Modified Ranking Score (mRS)

  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.

  30 days

• Ataxia

  Number of the partcipants with ataxia. 3 participants from neurology clinic were evaluated.

  30 days

• Physical Examination Scores Indicating Change in Muscle Strength

  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.

  30 days

• C-reactive Protein (CRP) Values

  Mean CRP (C-reactive protein) value (8 participants)

  30 days

• Erythrocyte Sedimentation Rate (ESR)

  Mean erythrocyte sedimentation rate (ESR) value (8 participants)

  30 days

• SAA (Serum Amyloid A)

  Mean Serum Amyloid A value (8 participants)

  30 days

• Hemoptysis

  The number of the participants with hemoptysis

  30 days

• Visual Analogue Scores (VAS) for Headache

  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.

  30 days

• Visual Analogue Scores (VAS) for Stomachache

  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.

  30 days

• Visual Analogue Scores (VAS) for Extremity Assessments

  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.

  30 days

• Visual Analogue Scores (VAS) for Patients' General Assessments

  Participants assessed their own well-being with VAS (visual analogue scale). Score 0 means the best outcome, score 10 is the worst outcome.

  30 days

• Physician's Global Assessment

  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

  30 days

• Steroid Dose Regimen

  Mean steroid treatment dose (8 participants)

  30 days

• BDCAF (Behçet's Disease Current Activity Form)

  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.

  30 days

• Extremity (Localized) Pain Assessment (VAS)

  Localized pain in the extremities were assessed by visual analogue scale scores ranging between Scale; 0 is the best outcome; 10 is worst.

  30 days

Study Arms (1)

Canakinumab

EXPERIMENTAL

Canakinumab was administered monthly

Drug: Canakinumab

Interventions

Canakinumab DRUG

150 mg or 300 mg of canakinumab was administered monthly. IV (SC after month 6)

Also known as: ACZ885

Canakinumab

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Behcet Syndrome; Inflammation; Arthritis

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases

Limitations and Caveats

This was an exploratory trial that was not powered for a statistical analysis.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+1 (862) 778-8300

Study Officials

• Ahmet Gül, Prof

  IU Faculty of Medicine

  STUDY CHAIR

• Murat Kurtuncu, Ass.Prof

  IU Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Gulsen Akman Demir, Prof

  Bilim University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 29, 2016
• Study Start: June 23, 2016
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: June 11, 2020
• Results First Posted: June 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The publication has been planned for Q4 2020.
• Access Criteria: Access from peer reviewed journal

Locations

TU (1)