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 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
NCT ID:
NCT02922192
Eligibility Criteria:
Inclusion Criteria:
* Individuals with baseline period of 365 days with continuous medical and pharmacy coverage preceding the first prescription fill
* new and users of the following exposures
* TNF -α antagonists (including adalimumab, certolizumab, etanercept \[not included for IBD\], golimumab, infliximab, and natalizumab \[IBD only\])
* Non-TNF-alpha antagonist biologics in RA only (abatacept, rituximab, and tocilizumab)
* Non-biologic medications (after any use of methotrexate in the previous year includes RA: hydroxychloroquine, leflunomide, or sulfasalazine; IBD: 6- mercaptopurine or azathioprine; PsO-PsA-AS: methotrexate, leflunomide, or sulfasalazine).
Exclusion Criteria:
* During baseline 365 days, any patient with
* Active cancer or a history of non-melanoma cancer\*
* Any immunocompromising conditions (organ transplantation, HIV, and advanced kidney/liver disease)\*
* \*if occur during the follow-up period, patients also will be censored.
* During baseline 183 days, any patient with hospitalization for any infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02922192
Study Brief:
Protocol Section:
NCT02922192