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 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT01197066
Eligibility Criteria:
Inclusion Criteria:
* Failed to achieve an ACR20 response at Week 12 in the Study 101-KOA-0801i or completed the entire Study 101-KOA-0801i through Week 24
* Have a clear chest X-ray at the Entry visit
* Negative urine pregnancy test at the Entry
* Continue treatment on methotrexate
Exclusion Criteria:
* Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
* Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
* At study entry taking any of the prohibited medications as detailed in the Study (Protocol) # 101-KOA-0801i
* NYHA (New York Heart Association) Class III or IV congestive heart failure
* Current or history of tuberculosis
* History of chronic infection, recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
* History of a lymphoproliferative disorder including lymphoma or signs and symptoms suggesting lymphoproliferative disease
* High risk of infection
* Female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01197066
Study Brief:
Protocol Section:
NCT01197066