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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT01083160
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥18 and \<75 years of age that meet the American College of Rheumatology (ACR) criteria for RA.
* Patients with active RA defined as:
1. ≥3 tender joints and ≥3 swollen joints, or
2. DAS 28 score \>3.1
* Patients who are discontinuing treatment with either infliximab or etanercept due to:
1. Lack of efficacy, or
2. Incomplete response.
* Patients that, in the opinion of the physician could result beneficiated with the locally approved treatment scheme of adalimumab
* Those patients who switch from infliximab or etanercept to adalimumab has been done in the last 60 days could be included in the study.
Exclusion Criteria:
The following patients will not be included in the study:
* Patients who have active infections.
* Patients with latent TB. For this protocol, evidence of latent TB infection is defined as an induration (not erythema) of 5 mm or greater, 48-72 hrs after placement. Any suggested data on the clinical history or chest x-ray.
* Patients participating into another study or clinical trial
* Any condition that according to the criteria of the participating physician represents an obstacle for study conduct and/or represents a potential unacceptable risk for patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01083160
Study Brief:
Protocol Section:
NCT01083160