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:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT00035958
Eligibility Criteria:
Inclusion criteria at the time of enrollment:
* Definite or probable diagnosis of JDMS by the criteria of Bohan and Peter
* No prior systemic steroid treatment for JDMS
* If able to become pregnant (females) or impregnate (males) and are sexually active, then must have negative serum pregnancy test at baseline and be utilizing effective form of birth control
* Patient and/or parent or legal guardian must be willing to sign consent and assent forms
Exclusion criteria at the time of enrollment:
* History of chronic or recurrent infections sufficient to preclude the use of etanercept
* Prior treatment with specific TNF-blocking agents
* Demonstration of cutaneous or gastrointestinal (GI) ulceration at the time of diagnosis
* JDMS-related pulmonary disease at time of diagnosis (interstitial lung disease or aspiration pneumonia confirmed by radiograph)
* JDMS-related cardiomyopathy (echocardiogram confirmation)
* Any uncontrolled, clinically significant pre-existent systemic disease (hepatic, renal, neurological, endocrine, cardiac, gastrointestinal, or hematologic disease) within 24 weeks of start of study
* Known HIV, hepatitis B surface antigen not related to vaccination, or hepatitis C antibody positivity
* Pregnant or nursing female
* Any of the following laboratory abnormalities at baseline: platelet count \< 100,000/cmm, total white cell count of \< 3000 cells/cmm, neutrophils \< 1000 cells/cmm, serum bilirubin \> 2 times upper limit of normal, estimated creatinine clearance of \< 90 mL/min/1.73 M2 BSA estimated by formula for males age 2 to \<13 (0.55 X ht in cms/serum creatinine), age 13-18 (0.7 X ht in cms/serum creatinine) and females age 2-18 (0.55 X ht in cms/serum creatinine)
* Received live virus vaccination within 3 months prior to study entry (contraindication for MTX or etanercept therapy)
* Past or current substance abuse or psychiatric history that would interfere with ability to give informed consent or comply with study requirements or physician instructions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
16 Years
Study:
NCT00035958
Study Brief:
Protocol Section:
NCT00035958