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:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT01571206
Eligibility Criteria:
Inclusion Criteria:
* Patient who has completed the scheduled visits, including the End-of-Study Visit, in Study CT-P13 1.1
* Patient who has not had any major protocol violation in Study CT-P13 1.1
Exclusion Criteria:
* Patient who has been withdrawn from Study CT-P13 1.1 for any reason
* Patient who, at the time of providing informed consent, has any ongoing medical issues such as serious adverse events(SAEs) or intolerance issues that mean continuation in this extension study could be detrimental to their health, in the option of the investigator
* Patient who plans to participate in a study with an investigational drug during the period of this extension study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01571206
Study Brief:
Protocol Section:
NCT01571206