Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT01668004
Brief Summary:
The objective of this study is to determine the difference in the annual incidence rate of uveitis attacks in participants with ankylosing spondylitis (AS) before start initial anti-TNF therapy and after treatment with golimumab (GLM).
Detailed Description:
This is an open-label, history-controlled, multi-site study of GLM in participants with AS. For evaluation of the primary study outcome measure, participants will serve as their own control. The period before start of treatment with an anti-tumor necrosis factor (TNF) agent will serve as historical control for the incidence of extra-articular manifestations, with a review of the medical records done for the previous 1-year period.
Each participant will participate in the study for approximately 12 months from the time the participant signs the Informed Consent Form through the final contact. After screening, two to four weeks before study start, each participant will be receiving study treatment for approximately 12 months, depending on the response to GLM after 3 months. All participants will be followed for a minimum of 12 months, irrespective of the duration of GLM treatment.
Study:
NCT01668004
Study Brief:
Protocol Section:
NCT01668004