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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT01033656
Eligibility Criteria:
Inclusion Criteria:
* Must be diagnosed with AOSD according to preliminary classification by Yamaguchi (1992).
* Other diseases with similar symptoms must be excluded. Has been exposed to a corticosteroid for ≥2 months prior to randomization for AOSD.
* Needs a prednisolone dose ≥10 mg/day or equivalent, yet unacceptable disease activity determined by the investigator.
* Anti-TNF agents must be discontinued 4 to 8 weeks prior to commencing study medication.
Exclusion Criteria:
* Use of corticosteroids (prednisolone equivalent \<10 mg/day.
* History of recurrent or chronic infection, including:
* tuberculosis
* any malignancy
* any other major chronic inflammatory disease syndrome
* drug or alcohol abuse
* known positivity for hepatitis B, C or HIV.
* Use of anti-TNF agents during ≤4 weeks (etanercept) or≤8 weeks (infliximab or adalimumab) prior to randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01033656
Study Brief:
Protocol Section:
NCT01033656