- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01693653
Tocilizumab for the Treatment of Behcet's Syndrome
This is a double-blind placebo controlled study targeting individuals with active Behcet's Syndrome who have oral ulcers and are resistant (have not responded after 4 weeks) to conventional treatments. Maximum allowable dose of colchicine (0.6mg twice a day) and stable dose for 4 weeks before enrollment. Prednisone or equivalent (< 10mg/day) permitted if dose stable for 6 weeks prior to enrollment.
The study will investigate the safety of tocilizumab for this vasculitic condition in addition to its efficacy.
The planned sample size is 30 participants per arm for a total of 60 participants. The study would be for 3 months, with a safety follow up at 2 months after study termination.
Study participants will stay on their current treatments and either tocilizumab or placebo infusions will be given every 4 weeks in addition. Patients will be randomized to Actemra IV 8mg/kg Q 4 weeks X 3 doses or placebo.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Center for Musculoskeletal Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any patient with BS with at least 1 active oral ulcer resistant (have not responded after 4 weeks to colchicine or local measures.
- dose (maximum allowable 0.6mg twice a day ) stable for 4 weeks and prednisone or equivalent (maximum dose < 10mg/day) stable for 6 weeks prior to enrollment.
- Patients must have Behcet's syndrome based on International Study Group criteria.
Patients will be included in the trial based on the following criteria:
- Normal organ function, except if abnormal due to the disease under investigation such as mucocutaneous involvement or joint involvement.
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment.
- Subject has provided written informed consent.
Exclusion Criteria:
- Patients with eye, CNS, vascular involvement such as DVT, thrombosis, or aneurysms.
- Patients who are currently being treated or have been exposed in the last 3 months to other immunosuppressive medications (azathioprine, TNF inhibitors, methotrexate, mycophenolate mofetil). Patients who are currently being treated or have been exposed to Cyclosporine or cyclophosphamide in the past 6 months will be excluded).
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening.
- Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples are CAMPATH, anti-CD4, anti-CD5, anti¬CD3, anti-CD19 and anti-CD20 (please note exceptions above).
- Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline.
- Immunization with a live/attenuated vaccine within 4 weeks prior to baseline.
- Previous treatment with TCZ (an exception to this criterion may be granted for single dose exposure upon application to the sponsor on a case-by-case basis).
- Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
- History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
- Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn's disease.)
- Current liver disease as determined by principal investigator unless related to primary disease under investigation
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, Hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds).
- Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
- Active TB requiring treatment within the previous 3 years. Patients should be screened for latent TB and, if positive, treated following local practice guidelines prior to initiating TCZ. Patients treated for tuberculosis with no recurrence in 3 years are permitted. (Appendix 8)
- Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation.
- Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (including hematological malignancies and solid tumors, except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured), or breast cancer diagnosed within the previous 20 years unless related to primary disease under investigation.
- Pregnant women or nursing (breast feeding) mothers.
- Patients with reproductive potential not willing to use an effective method of contraception.
- History of alcohol, drug or chemical abuse within 1 year prior to screening.
- Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation.
Patients with lack of peripheral venous access.
Laboratory Exclusion criteria (at screening):
- Serum creatinine > 1.6 mg/dL (141 µmol/L) in female patients and > 1.9 mg/dL (168 µmol/L) in male patients. Patients with serum creatinine values exceeding limits may be eligible for the study if their estimated glomerular filtration rates (GFR) are >30.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times upper limit of normal (ULN)
- Total Bilirubin > ULN
- Platelet count < 100 x 109/L (100,000/mm3)
- Hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L)
- White Blood Cells < 3.0 x 109/L (3000/mm3)
- Absolute Neutrophil Count < 2.0 x 109/L (2000/mm3)
- Absolute Lymphocyte Count < 0.5 x 109/L (500/mm3)
- Positive Hepatitis BsAg, or Hepatitis C antibody
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Tocilizumab
tocilizumab infusion every 4 weeks over 3 months
|
Intravenous infusions every 4 weeks for 3 doses.
Other Names:
|
Placebo Comparator: Placebo
placebo infusion 0.9% sodium chloride every 4 weeks over 3 months
|
Intravenous infusions every 4 weeks for 3 doses.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Outcome
Time Frame: 9 months
|
The study was terminated.
No data were collected for this Outcome Measure.
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genital Ulcers
Time Frame: 9 months
|
The study was terminated.
No data were collected for this outcome measure.
|
9 months
|
Oral Ulcers
Time Frame: 9 months
|
The study was terminated.
No data were collected for this outcome measure.
|
9 months
|
Treatment Failures
Time Frame: 9 months
|
The study was terminated.
No data were collected for this outcome measure.
|
9 months
|
Oral Ulcer Pain
Time Frame: 9 months
|
The study was terminated.
No data were collected for this outcome measure.
|
9 months
|
Gential Ulcer Pain
Time Frame: 9 months
|
The study was terminated.
No data were collected for this outcome measure.
|
9 months
|
BSAS
Time Frame: 9 months
|
The study was terminated.
No data were collected for this outcome measure.
|
9 months
|
MDHAQ
Time Frame: 9 months
|
The study was terminated.
No data were collected for this outcome measure.
|
9 months
|
BDCAF
Time Frame: 9 months
|
The study was terminated.
No data were collected for this outcome measure.
|
9 months
|
Safety
Time Frame: 9 moths
|
The study was terminated.
No data were collected for this outcome measure.
|
9 moths
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yusuf Yazici, MD, NYU Langone Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Eye Diseases
- Disease
- Genetic Diseases, Inborn
- Stomatognathic Diseases
- Mouth Diseases
- Uveitis, Anterior
- Panuveitis
- Uveitis
- Uveal Diseases
- Vasculitis
- Hereditary Autoinflammatory Diseases
- Skin Diseases, Genetic
- Skin Diseases, Vascular
- Syndrome
- Behcet Syndrome
Other Study ID Numbers
- 12-01182
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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