BEH¿ET¿S DISEASE REFRACTORY TO STANDARD OF CARE THERAPIES MedDRA version: 20.0 Level: LLT Classification code 10004215 Term: Behcets disease System Organ Class: 100000004866
Conditions
Interventions
Trade Name: HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 1 SIRINGA PRERIEMPITA 0.8 ML + 1 TAMPONE IMBEVUTO DI ALCOL IN UN BLISTER
Product Name: HUMIRA
Product Code: HUMIRA
Pharmaceutical Form
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject’s written informed consent given before any study-related procedure not part of the subject’s normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his or her future medical care; -Age >=18-=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Actual “end-stage” BD, with severe retinal damage or central nervous system (CNS) irreversible damage; -Visual acuity < 1/10 on Snellen chart in both eyes or bilateral permanent blindness; -Other severe BD manifestations, i.e. arterial aneurysm, thrombosis of the caval, hepatic veins, or cerebral sinuses; -Any infection at screening or frequent acute or chronic infections within 3 months prior to the study entry; -Congestive heart failure; -Multiple sclerosis or any other central demyelinating disorder; -History of malignancy within previous 5 years (except curatively excised skin cancer); -Transplanted organ (except cornea); -Substance abuse within 3 years; -Enrollment in other investigative clinical trial; -Prior history of anti TNF alpha agents’ or other monoclonal antibody treatments, or known allergy to murine or chimeric proteins - Hypersensitivity to the active substances or to any of the excipients - History of HIV, HCV or HBV infections. At the screening a specific test to assess the seronegativity to the viruses should be performed. - No subjects with current active TB may be enrolled in the study. -Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test; -Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the entire study; -History of poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Efficacy Objective The primary objective of the study is to evaluate the effectiveness of either 6-month infliximab-IFX or adalimumab-ADA course following an induction with systemic corticosteroids and defined by the time to response of ocular and/or neurological and/or muco-cutaneous manifestations of Behcet¿s disease that have been occurred despite at least 3-month immunosuppressive standard of care therapy with azathioprine or cyclosporine Primary Safety Objective The safety and tolerability profiles of anti TNF alpha agents will be evaluated as the frequency of adverse events (AEs) and serious adverse events (SAEs) during the course of study. ;Secondary Objective: Secondary objectives will be the evaluation during all the treatment period including the follow up time of: - the proportion of BD subjects who will have a relapse of ocular, neurological or muco-cutaneous manifestations while on anti TNF alpha agents; - the adherence to the IMPs defined as the administration/intake >70% of anti TNF alpha agents in the considered period; - the retention on anti TNF alpha agents and reasons of withdrawal; - their effects on quality of life measured by the NEI-VFQ25. ;Primary end point(s): Primary study endpoint will be the time to response of sight-threatening uveitis and/or neurological and/or muco-cutaneous manifestations over 6-month antiTNFalpha agents’ treatment.;Timepoint(s) of evaluation of this end point: 6-month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objectives will be the evaluation during all the treatment period including the follow up time of: - the proportion of BD subjects who will have a relapse of ocular, neurological or muco-cutaneous manifestations while on anti TNF alpha agents; - the adherence to the IMPs defined as the administration/intake >70% of anti TNF alpha agents in the considered period; - the retention on anti TNF alpha agents and reasons of withdrawal; - their effects on quality of life measured by the NEI-VFQ25. ;Timepoint(s) of evaluation of this end point: 3 years | — |
Countries
Italy
Contacts
Public ContactUO REUMATOLOGIA
UO REUMATOLOGIA
Outcome results
None listed