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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03371095
Date of registration: 07/12/2017
Prospective Registration: Yes
Primary sponsor: Assistance Publique - Hôpitaux de Paris
Public title: Induction Therapy With Anti-TNFa vs Cyclophosphamide in Severe Behçet Disease ITAC
Scientific title: Multicenter, Randomized, Prospective Trial Comparing the Efficacy and Safety of Infliximab to That of Cyclophosphamide in Severe Behçet's Disease. ITAC : Induction Therapy With Anti-TNFa vs Cyclophosphamide in Severe Behçet Disease
Date of first enrolment: March 15, 2018
Target sample size: 52
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT03371095
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Contacts
Name:     David SAADOUN, Pr
Address: 
Telephone: 142178088
Email: david.saadoun@psl.aphp.fr
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 12 years old

- Written inform consent (Informed Consent should be obtained from the legal guardian in
accordance with regional laws or regulations for patients 12 to 17 years of age)

- Diagnosis of BD according to international criteria for BD (ICBD) (see Appendix 1).

- Life threatening active BD defined as 1 of the following disease categories and
according to the validated international definition:

- Major vessel disease: arterial aneurysms or arterial stenosis, myocarditis and/or
major deep vein thrombosis (i.e. inferior vena cava, superior vena cava, cardiac
cavity thrombosis, pulmonary embolism, supra-hepatic vessels, renal and
mesenteric vessels). Diagnosis of major vessel involvement will be done using
vascular doppler sonography, echocardiography, angio-CT scan and/or cardiac
magnetic resonance imaging (MRI).

- Central nervous system involvement: encephalitis or meningoencephalitis or
myelitis. The diagnosis of neuro-Behçet's (CNS involvement) will be based on
objective neurological symptoms that were associated with neuroimaging (CNS
and/or medullar MRI) findings suggestive of BD-related CNS involvement.
Cerebrospinal fluid (CSF) findings showing aseptic inflammation may be
associated.

- Chest X-ray results (postero-anterior and lateral) within 12 weeks prior to inclusion
with no evidence of active Tuberculosis, active infection, or malignancy

- For female subjects of child-bearing age, a negative pregnancy test

- For subjects with reproductive potential, a willingness to use contraceptive measures
adequate to prevent the subject or the subject's partner from becoming pregnant during
the study and 6 months after stopping therapy. Adequate contraceptive measures include
hormonal methods used for two or more cycles prior to Inclusion (e.g., oral
contraceptive pills, contraceptive patch, or contraceptive vaginal ring), barrier
methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive
foam or jelly, or condom used in conjunction with contraceptive foam or jelly),
intrauterine methods (IUD), sterilization (e.g., tubal ligation or a monogamous
relationship with a vasectomized partner), and abstinence.

- A potential subject with a positive interferon-gamma release assay (IGRA) (e.g.,
QuantiFERON®-TB Gold or T-spot TB® Test) or a positive tuberculin skin test (=6
months) is eligible if her/his chest X-ray does not show evidence suggestive of active
tuberculosis (TB) disease and there are no clinical signs and symptoms of pulmonary
and/or extra-pulmonary TB disease. These subjects with a latent TB infection who have
not already received a prophylactic TB treatment must agree in advance to complete
such a treatment course.

- HIV negative serology and negative HBs Ag test (=1 month)

Exclusion Criteria:

- Evidence of active Tuberculosis

- HIV or active HBV infection (HBs Ag+).

- Pregnancy or lactation

- Have been taking an oral daily dose of a glucocorticoid of more than 20 mg prednisone
equivalent for more than 6 weeks continuously prior to the inclusion visit or taking
more than 3000 mg methylprednisolone 4 weeks prior to the inclusion visit

- Alcohol or drug dependance

- Severe renal (creatinine clearance <30ml/min/1,73m2) or pre-existing hemorrhagic
cystitis or liver insufficiency (hepatic encephalopathy, ascites)

- Heart failure = stage III / IV NYHA,

- History of malignancy within 5 years prior to Inclusion other than carcinoma in situ
of the cervix or excised basal cell or squamous cell carcinoma of the skin.

- History of multiple sclerosis and/or demyelinating disorder

- History of severe allergic or anaphylactic reactions to cyclophosphamide or infliximab

- Infectious disease:

- Infection requiring treatment with antibiotics within 2 weeks prior to Inclusion

- History of recurrent infection

- Laboratory values assessed during Inclusion:

- Hemoglobin < 8 g/dL

- WBC < 2.0 x 103/mm3

- Platelet count < 70 x 103/mm3

- Use of the following systemic treatments during the specified periods:

- Treatment with systemic biologic therapy or with cyclophosphamide within 3 months
prior to Inclusion

- if on azathioprine, mycophenolate mofetil, or methotrexate at the time of
inclusion, these drugs must be withdrawn prior to receiving the cyclophosphamide
or infliximab dose on Day 1

- Any live (attenuated) vaccine within 4 weeks prior inclusion; recombinant or killed
virus vaccines are permitted.

- Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)



Age minimum: 12 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Behcet's Disease
Vasculitis
Intervention(s)
Drug: Cyclophosphamide
Drug: Infliximab
Primary Outcome(s)
Complete clinical response [Time Frame: At week 22 after randomization]
Secondary Outcome(s)
C-reactive protein [Time Frame: Every 4 weeks]
Change in Behcet's Disease Current Activity Form [Time Frame: At week 12 after randomization]
Change in Behcet's Disease Current Activity Form [Time Frame: At week 22 after randomization]
Change in quality of life [Time Frame: At week 12 after randomization]
Change in quality of life [Time Frame: At week 22 after randomization]
Changes in cardiological involvement [Time Frame: At week 12 after randomization]
Changes in cardiological involvement [Time Frame: At week 22 after randomization]
Changes in CNS involvement [Time Frame: At week 12 after randomization]
Changes in CNS involvement [Time Frame: At week 22 after randomization]
Changes in vascular involvement [Time Frame: At week 12 after randomization]
Changes in vascular involvement [Time Frame: At week 22 after randomization]
Complete clinical response [Time Frame: At week 12 after randomization]
Complete clinical response [Time Frame: At week 48 after randomization]
Cumulative dose of prednisone [Time Frame: At week 12 after randomization]
Cumulative dose of prednisone [Time Frame: At week 22 after randomization]
Cumulative dose of prednisone [Time Frame: At week 48 after randomization]
Event Free Survival [Time Frame: At week 48 after randomization]
Frequency of adverse clinical events [Time Frame: At week 22 after randomization]
Mean dose of prednisone [Time Frame: At week 12 after randomization]
Mean dose of prednisone [Time Frame: At week 22 after randomization]
Mean dose of prednisone [Time Frame: At week 48 after randomization]
Overall survival [Time Frame: At week 48 after randomization]
Percent meeting the target of = 0.1 mg/day/kg of prednisone [Time Frame: At week 22 after randomization]
Percent meeting the target of = 0.1 mg/day/kg of prednisone [Time Frame: At week 48 after randomization]
Rate of relapse [Time Frame: At week 48 after randomization]
Rate of worsening [Time Frame: At week 48 after randomization]
Remission of CNS and/or cardiovascular involvement [Time Frame: At week 12 after randomization]
Remission of CNS and/or cardiovascular involvement [Time Frame: At week 22 after randomization]
Remission of CNS and/or cardiovascular involvement [Time Frame: At week 48 after randomization]
Serum concentration measurement of TNFa inhibitor at week 22 [Time Frame: At week 12 after randomization]
Severity of adverse clinical events [Time Frame: At week 22 after randomization]
Time to occurrence of worsening [Time Frame: At week 48 after randomization]
Time to relapse [Time Frame: At week 48 after randomization]
Time to response onset [Time Frame: At week 48 after randomization]
Secondary ID(s)
P160932J
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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