Behcet Syndrome Clinical Trial
Official title:
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.
Behcet's syndrome is a vasculitis that causes oral and genital ulcerations, skin lesions, eye disease and arthritis, in addition to vascular complications with thrombophlebitis, thrombosis and rarely central nervous system involvement. IL-6 activity has been suggested in the pathogenesis in some studies. Tocilizumab with its unique mode of action among biologic agents may be a good candidate in this orphan disease. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03274648 -
Dietary Interventions and Butyrate Production in Behçet's Patients
|
N/A | |
Completed |
NCT04961463 -
Evaluation of the Psychoeducation Program Given to Behcet's Patients in the Context of the Roy Adaptation Model
|
N/A | |
Completed |
NCT05142995 -
Sleep Related Breathing Disorders, Anxiety, Depression and Quality of Life Assessment in Behcet's Disease
|
||
Recruiting |
NCT00931957 -
Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
|
N/A | |
Completed |
NCT03514056 -
Frequency of Fibromyalgia in Behcet Disease
|
||
Not yet recruiting |
NCT03771768 -
Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease
|
N/A | |
Terminated |
NCT03554161 -
Tocilizumab for the Treatment of Refractory Behcet's Uveitis
|
Phase 2 | |
Recruiting |
NCT04738864 -
Neuro-ultrasound Assessment in Behcet's Disease
|
N/A | |
Completed |
NCT03264391 -
Evaluation of Macular Vascular Changes in Behcet's Disease Using Optical Coherence Tomography Angiography
|
||
Completed |
NCT04386824 -
Erectile Dysfunction in Patients With Non Ocular Behçet's Disease
|
||
Completed |
NCT03962335 -
Gut Microbiota and Behcet's Syndrome: a Dietary Intervention Trial (MAMBA Study)
|
N/A | |
Completed |
NCT01532570 -
Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions
|
Phase 3 | |
Not yet recruiting |
NCT04186559 -
Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers
|
Phase 2 | |
Terminated |
NCT04218565 -
Golimumab for the Treatment of Refractory Behcet's Uveitis
|
Phase 2 | |
Not yet recruiting |
NCT03747354 -
Assessment of Disease Activity in Behcet by Complete Blood Count
|
N/A | |
Recruiting |
NCT05200715 -
AutoInflammatory Disease Alliance Registry (AIDA)
|
||
Completed |
NCT05098678 -
Zinc Supplementation and Behçet's Syndrome
|
N/A | |
Completed |
NCT00866359 -
A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease
|
Phase 2 | |
Completed |
NCT00483184 -
Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease
|
Phase 2 | |
Completed |
NCT05032248 -
Uses of Tacrolimus in Behcet Disease
|
N/A |