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 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT01668966
Eligibility Criteria:
Inclusion Criteria:
* Participants who completed their last WA19926 (NCT01649804) core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
* No current or recent adverse event or laboratory finding preventing the use of tocilizumab 8 mg/kg at baseline visit
* Women of childbearing potential must agree to use highly reliable contraception during the treatment period
Exclusion Criteria:
* Pregnant or breastfeeding females
* Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study for any reason
* Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926 (NCT01649804)
* Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926 (NCT01649804)
* Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926 (NCT01649804)
* Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of rheumatic autoimmune disease other than RA
* Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of inflammatory joint disease other than RA
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients
* Evidence of severe uncontrolled concomitant disease or disorder
* Known active infections or history of recurrent infections
* Active tuberculosis requiring treatment in the previous 3 years
* History of alcohol, drug or chemical abuse since inclusion in the WA19926 (NCT01649804) study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Months
Study:
NCT01668966
Study Brief:
Protocol Section:
NCT01668966