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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT01782469
Eligibility Criteria:
Inclusion Criteria:
A patient will be enrolled in this study if he/she fulfills ALL of the following criteria:
* Male or Female patients ≥ 18 years of age with diagnosis of RA
* Patient is eligible to start adalimumab therapy according to the local product label and prescription guidelines
* Patient is naïve to all biologics e.g. anti-cluster of differentiation 4 (anti-CD4) and anti-TNF treatments at the start of the study
* Patient has no history of inflammatory arthritis other than rheumatoid arthritis
* Patient has no history of lymphoma or leukemia or other malignancies
* Has negative result of tuberculosis (TB) screening test or is receiving TB prophylaxis as per local guidelines, Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations
Exclusion Criteria:
* Patients that are not diagnosed with rheumatoid arthritis as judged by the American College of Rheumatology criteria
* Patient is currently diagnosed with any condition other than rheumatoid arthritis that may affect radiography progression
* Susceptibility to infections including TB, as judged by the investigator
* Patient is carrier of Hepatitis B virus
* Patient is a pregnant or lactating female at the time of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01782469
Study Brief:
Protocol Section:
NCT01782469