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:
NCT00356356
Eligibility Criteria:
Inclusion Criteria: - Subjects completing 24 weeks of study drug in protocol 16.0037 qualify to enroll into this study Other patients to meet the following criteria:
* Negative pregnancy test
* Subjects agree to use appropriate contraception throughout study
* Should be able to self-inject study drug or have someone who can do so
* Capable of understanding protocol and willing to provide written informed consent
Exclusion Criteria:
* Any change in NSAID or prednisone dose within 2 weeks of baseline
* Any change in hydroxychloroquine, sulfasalazine, or MTX dose within 4 weeks of baseline
* Use of DMARDs other than those mentioned above, within 4 weeks of enrollment
* Previous receipt of ani-TNF agents, other than etanercept
* Receipt of any other investigational drug within 30 days of baseline
* Grade 3 or 4 adverse event attributed to etanercept which recurred when etanercept was resumed
* Abnormality in chemistry or hematology profiles or significant concurrent medical events.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00356356
Study Brief:
Protocol Section:
NCT00356356