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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: EUCTR
Last refreshed on: 28 February 2019
Main ID:  EUCTR2017-002264-41-FR
Date of registration: 19/07/2017
Prospective Registration: Yes
Primary sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Public title: NA
Scientific title: Etude randomisée multicentrique évaluant l’efficacité et la tolérance de l’infliximab comparativement au Cyclophosphamide dans les formes sévères de maladie de Behçet " Multicenter, randomized, prospective trial comparing the Efficacy and Safety of Infliximab to that of Cyclophosphamide in severe Behçet's disease" - ITAC
Date of first enrolment:
Target sample size: 52
Recruitment status: NA
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002264-41
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
France
Contacts
Name: DRCI Hôpital St Louis   
Address:  1 av. Claude Vellefaux 75010 PARIS France
Telephone:
Email: houria.mebarek@aphp.fr
Affiliation:  ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Name: DRCI Hôpital St Louis   
Address:  1 av. Claude Vellefaux 75010 PARIS France
Telephone:
Email: houria.mebarek@aphp.fr
Affiliation:  ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Key inclusion & exclusion criteria
Inclusion criteria:
1. Age superior or equal 12 years old
2. 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)
3. Diagnosis of BD according to international criteria for BD (ICBD) (see Appendix 1).
4. 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.
6. Chest X-ray results (postero-anterior and lateral) within 12 weeks prior to inclusion with no evidence of active Tuberculosis, active infection, or malignancy
7. For female subjects of child-bearing age, a negative pregnancy test
8. 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.
9. 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 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.
10. HIV negative serology and negative HBs Ag test (?1 month)

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Evidence of active Tuberculosis
2. HIV or active HBV infection (HBs Ag+).
3. Pregnancy or lactation
4. 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
5. Alcohol or drug dependance
6. Severe renal (creatinine clairance <30ml/min/1,73m2) or liver insufficiency
7. Heart failure ? stage III / IV NYHA,
8. 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.
10. History of multiple sclerosis and/or demyelinating disorder
11. History of severe allergic or anaphylactic reactions to cyclophosphamide or infliximab
12. Infectious disease:
- Infection requiring treatment with antibiotics within 2 weeks prior to Inclusion
- History of recurrent infection
14. Laboratory values assessed during Inclusion:
- Hemoglobin < 8 g/dL
- WBC < 2.0 x 103/mm3
- Platelet count < 70 x 103/mm3
15. 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
16. Any live (attenuated) vaccine within 4 weeks prior inclusion; recombinant or killed virus vaccines are permitted.
17. Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Induction Therapy with Anti-TNF vs Cyclophosphamide in severe Behçet disease
MedDRA version: 20.0 Level: LLT Classification code 10004212 Term: Behcet's disease System Organ Class: 100000017240
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Remicade 100 mg
Product Name: Remicade 100 mg
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: infliximab
Other descriptive name: infliximab

Trade Name: cyclophosphamide
Product Name: cyclophosphamide
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: cyclophosphamide
Other descriptive name: cyclophosphamide

Primary Outcome(s)

Primary end point(s): Primary assessment criterion will be the complete clinical response at week 22 after randomization
secondary criteria:
To estimate and compare the rate and time to occurrence of relapses or worsening
To estimate and compare the cumulative dose of steroids
To estimate and compare the adverse events
To estimate and compare the mean change in SF-36 quality-of-life (see Appendix 3)
To estimate and compare the rate of remission according to organs involved
To compare the changes in acute-phase reactants,
To estimate and compare the changes in CNS involvement
To estimate and compare the changes in Cardio-vascular involvement
Survival and event free survival
To estimate and compare the changes in other BD manifestations
To estimate and compare the changes in Behcet's Disease Current Activity Form (see Appendix 2)
To assess serum concentration measurement of TNFa inhibitor

Secondary Objective: To estimate and compare the rate and time to occurrence of relapses or worsening
To estimate and compare the cumulative dose of steroids
To estimate and compare the adverse events
To estimate and compare the mean change in SF-36 quality-of-life
To estimate and compare the rate of remission according to organs involved
To compare the changes in acute-phase reactants,
To estimate and compare the changes in CNS involvement
To estimate and compare the changes in Cardio-vascular involvement
Survival and event free survival
To estimate and compare the changes in other BD manifestations
To estimate and compare the changes in Behcet's Disease Current Activity Form (see Appendix 2)
To assess serum concentration measurement of TNFa inhibitor
To assess fertility in women with reproductive potential
Main Objective: To assess the benefit of infliximab comparatively to that of cyclophosphamide in severe life-threatening Behçet's disease
Timepoint(s) of evaluation of this end point: LSLV
Secondary Outcome(s)

Secondary end point(s): Primary assessment criterion will be the complete clinical response at week 22 after randomization
secondary criteria:
To estimate and compare the rate and time to occurrence of relapses or worsening
To estimate and compare the cumulative dose of steroids
To estimate and compare the adverse events
To estimate and compare the mean change in SF-36 quality-of-life (see Appendix 3)
To estimate and compare the rate of remission according to organs involved
To compare the changes in acute-phase reactants,
To estimate and compare the changes in CNS involvement
To estimate and compare the changes in Cardio-vascular involvement
Survival and event free survival
To estimate and compare the changes in other BD manifestations
To estimate and compare the changes in Behcet's Disease Current Activity Form (see Appendix 2)
To assess serum concentration measurement of TNFa inhibitor
Timepoint(s) of evaluation of this end point: LSLV
Secondary ID(s)
P160932J
Source(s) of Monetary Support
DGOS
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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