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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT00160693
Eligibility Criteria:
Inclusion Criteria:
* Participation in CZP trial C87014 or C87011
* If female and of childbearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception since her last menses, will use adequate contraception during the study and for 12 weeks after the last dose of study drug (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the day of receiving the first dose of study drug
* Must have provided written informed consent before undergoing any study procedures
Exclusion Criteria:
* History (Hx) of chronic infection, serious or life-threatening infection - (including Herpes Zoster) within 6 months prior, or any current symptom indicating infection
* Current or recent Hx of severe, progressive and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
* Any finding indicative of Tuberculosis at end of previous study
* Known HIV infection
* Persistently abnormal AST (Aspartate Aminotransferase) or ALT (Alanine Aminotransferase) results (\> 2 times upper limit of normal)
* Hemoglobin (Hgb) levels \< 9 g/dL or Hematocrit \< 30 %
* Total White Blood Cell (WBC) count of \< 3.0 x 100/L (\< 3000/mm\^3)
* Platelet count \< 100 x 100 L (100,000/mm\^3)
* Serum creatinine \> 1.5 times upper limit of normal based on patient age and sex
* Receipt of any biological therapies for RA in 6 months prior to study entry or any prior treatment (tx) with Tumor Necrosis Factor (TNF) blocking agent (excluding CDP870)
* Receipt of any vaccination (live, attenuated or killed) in 8 weeks prior to Baseline
* Any other condition which the Principal Investigator judges would make patient unsuitable for study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00160693
Study Brief:
Protocol Section:
NCT00160693