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:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT01345318
Eligibility Criteria:
Inclusion Criteria:
* Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12 week) induction period.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Women of childbearing potential, who have sexual intercourse with a non surgically sterilized male partner, must agree and commit to the use highly effective methods of birth control from signing of the ICD through 26 weeks after the Final Study Evaluation or for 62 weeks from the last dose of investigational product for any subject who terminates early from this study.
Exclusion Criteria:
* Subjects that have completed Day 84 (Week 12) of study B0151003, and experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or inclusion in this study.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate entry into this study.
* Received any prohibited treatment during study B0151003 that, in the opinion of the investigator, compromised the safety or efficacy of this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01345318
Study Brief:
Protocol Section:
NCT01345318