- 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 been started on treatment with tofacitinib.
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.
- 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.