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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT01730456
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, \>/= 18 years of age
* Patients who complete their last WA19926 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 the study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit
* Receiving treatment on an outpatient basis
* Females of childbearing potential must agree to use at least one adequate method of contraception, including a method with a failure rate of \<1% per year, during the treatment period
Exclusion Criteria:
* Pregnant or lactating women
* Patients who have prematurely withdrawn from the WA19926 core study for any reason
* Treatment with an investigational agent or cell-depleting therapies since the last administration of study drug in the WA19926 core study
* Immunization with a live/attenuated vaccine since the last administration of study drug in the WA19926 core study
* Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
* Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis
* Inadequate liver, hematologic or renal function
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Known active or history of recurrent infections
* Evidence of active malignant disease, malignancies within the previous 10 years (except for basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years
* Uncontrolled disease states, such as asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01730456
Study Brief:
Protocol Section:
NCT01730456