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 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT00927927
Eligibility Criteria:
Inclusion Criteria:
* Active rheumatoid arthritis, characterized by a Disease Activity Score (DAS28) above 3.2, and a diagnosis of at least three months duration
* Aged between 18 and 75 years (both inclusive)
* Subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
* Use of highly effective contraception during the trial (both males and females)
Exclusion Criteria:
* A chronic inflammatory autoimmune or joint disease other than RA (rheumatoid arthritis)
* An active or latent tuberculosis
* Any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit
* A known significant cardio-vascular disease
* Vaccination against live virus or bacteria within 4 weeks prior to randomization
* The use of concomitant medications that are prohibited in the trial (e.g., certain DMARDs (antirheumatic therapies that are disease modifying), biologics (here: biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)
* A positive test result for human immunodeficiency virus (HIV) infection, hepatitis B and/or hepatitis C, or tuberculosis skin test
* Donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00927927
Study Brief:
Protocol Section:
NCT00927927