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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT01332994
Eligibility Criteria:
Inclusion Criteria:
* Adult patients \>/=18 years of age
* Body weight \< /=130kg
* Active rheumatoid arthritis of at least 6 months duration, diagnosed according to the American College of Rheumatology (ACR) criteria of 1987
* Disease Activity Score (DAS28) of \>3.2
* Inadequate clinical response to a stable dose of traditional Disease-Modifying Anti-Rheumatic Drugs (DMARD)
* Have received permitted DMARDs, one or more; current DMARD therapy must have been at stable dose for at least 4 weeks prior to baseline
Exclusion Criteria:
* Prior treatment with TNF-inhibitors or other biologic DMARD
* Major surgery (including joint surgery) within eight weeks prior to baseline or planned major surgery within the study duration
* Functional class IV (American College of Rheumatology classification)
* Rheumatic autoimmune disease other than rheumatoid arthritis
* History of or current inflammatory joint disease other than rheumatoid arthritis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01332994
Study Brief:
Protocol Section:
NCT01332994