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 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT04079920
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects with moderately to severely active rheumatoid arthritis who start treatment with tofacitinib in usual clinical practice conditions in compliance with the label
1. Patients aged ≥ 18 years
2. Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist
3. Patients with moderate to severe RA diagnosed according to local practice who have already been started on treatment with tofacitinib, for at most seven working days .
4. Patients eligible for tofacitinib treatment according to current approved Summary of Product Characteristics (SmPC).
5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria:
* Patients meeting any of the following criteria will not be included in the study:
1. Exclusion Criteria according to the Xeljanz® SmPC.
2. Contraindications to Xeljanz® according to SmPC.
3. Hypersensitivity to the active substance (tofacitinib) or to any of the excipients.
4. Active tuberculosis (TB), serious infections, such as sepsis, or opportunistic infections.
5. Receipt of any investigational drug within 3 months before study inclusion as well as currently not participating in an interventional clinical trial.
6. Subjects who have received any previous treatment with tofacitinib or other JAK inhibitors.
7. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04079920
Study Brief:
Protocol Section:
NCT04079920