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 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT01734993
Eligibility Criteria:
Inclusion Criteria:
* Negative pregnancy test at screening and baseline
* Participants who have completed the 97-week WA22762 LTE study on SC or intravenous (IV) TCZ and who experienced, at any time during WA22762, clinically significant improvement in DAS28 (\>1.2 points), and based on the investigator's judgment may continue to benefit from TCZ treatment in this study investigating the SC formulation
* No current or recent adverse events or laboratory findings preventing the use of the study drug dose of TCZ 162 mg SC at baseline visit
* Receiving treatment on an outpatient basis
* Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception during the study and for at least 3 months following the last dose of study drug
* Oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) up to the recommended dose are permitted if on stable dose regimen for greater than and equal to (\>/=) 4 weeks prior to baseline
* Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed
Exclusion Criteria:
* Participants who have prematurely withdrawn from the WA22762 LTE study for any reason
* Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies
* Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell co stimulation modulator since the last administration of study drug in the WA22762 LTE study
* Immunization with a live/attenuated vaccine since the last administration of study drug in the WA22762 LTE study
* Diagnosis, since last WA22762 visit (Week 97), of rheumatic autoimmune disease other than rheumatoid arthritis; secondary Sjörgen's syndrome with RA is permitted
* Diagnosis, since last WA22762 visit (Week 97), of inflammatory joint disease other than RA
* Uncontrolled disease states, such as asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
* Evidence of serious uncontrolled concomitant disease
* Known active current or history of recurrent infection
* Primary or secondary immunodeficiency (history of or currently active)
* Body weight \>150 kilograms (kg)
* Pregnant or lactating women
* Inadequate hematologic, renal or liver function
* History of alcohol, drug or chemical abuse within 1 year prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01734993
Study Brief:
Protocol Section:
NCT01734993