Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT00866359
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Behçet Disease. At the time of diagnosis, subjects must meet the international study group criteria for Behçet Disease
* Females of childbearing potential (FCBP) must have negative pregnancy tests and agree to use two forms of contraception throughout the study.
* Males must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP
* Laboratory criteria: Hgb ≥ 9 g/dL, WBC count ≥ 3000 /microL and ≤14,000/microL, platelet count ≥ 100,000 /microL,, serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L), total bilirubin ≤ 2.0 mg/dL, AST and ALT ≤ 1.5 X ULN
* Two or more oral ulcers over the 28 day period before screening, with or without current treatment
* Two or more oral ulcers at the time of randomization (Visit 2, Baseline)
Exclusion Criteria:
* Pregnant or breast feeding
* Any condition which places the subject at risk
* Systemic fungal infection
* History of TB infection within 3 years
* History of recurrent bacterial infection
* Mycobacterium TB as indicated by a positive PPD skin test
* History of incompletely treated Mycobacterium tuberculosis
* Clinically significant chest x-ray abnormality at screening.
* Clinically significant ECG abnormality at screening
* History of HIV infection
* History of congenital or acquired immunodeficiency
* Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
* Antibodies to Hepatitis C at screening
* History of malignancy (except for treated basal-cell skin carcinomas \> 3 years prior to screening)
* Any active major organ involvement of Behçet Disease
* Use of concomitant immune modulating therapy or topical corticosteroids.
* Use of ocular corticosteroids
* Use of any investigational medication within 4 weeks prior to randomization or 5 PK/PD half-lives (whichever is longer)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00866359
Study Brief:
Protocol Section:
NCT00866359