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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT00412256
Eligibility Criteria:
Inclusion Criteria:
* written informed consent
* RA according to the ACR criteria
* active RA (DAS28 \> 4.0) at the screening visit
* insignificant DAS28-change (\<0.6) between screening and the first intervention
Exclusion Criteria:
* age lower than 18 yrs.
* pregnancy and insufficient birth control
* lactation
* army service
* lack of independence
* relevant therapeutic or dietary changes during the last three months
* relevant therapeutic or dietary changes foreseen for the study duration (including surgery)
* application of Omega-3 fatty acids during the last three months
* application of Omega-3 fatty acids intended for the study duration
* prednisolone \> 10 mg/day
* contraindication for Omegaven or Lipovenös (according to the label)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00412256
Study Brief:
Protocol Section:
NCT00412256