Status:
COMPLETED
Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients
Lead Sponsor:
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
This is a 24-month, prospective, non-interventional, multi-center study with primary aim to identify baseline characteristics of patients that predict response at 6 months of treatment. The study also...
Eligibility Criteria
Inclusion
- Adult subjects with moderately to severely active rheumatoid arthritis who start treatment with tofacitinib in usual clinical practice conditions in compliance with the label
- Patients aged ≥ 18 years
- Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist
- 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 .
- Patients eligible for tofacitinib treatment according to current approved Summary of Product Characteristics (SmPC).
- 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
- Patients meeting any of the following criteria will not be included in the study:
- Exclusion Criteria according to the Xeljanz® SmPC.
- Contraindications to Xeljanz® according to SmPC.
- Hypersensitivity to the active substance (tofacitinib) or to any of the excipients.
- Active tuberculosis (TB), serious infections, such as sepsis, or opportunistic infections.
- Receipt of any investigational drug within 3 months before study inclusion as well as currently not participating in an interventional clinical trial.
- Subjects who have received any previous treatment with tofacitinib or other JAK inhibitors.
- Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
Key Trial Info
Start Date :
September 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 8 2023
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT04079920
Start Date
September 22 2020
End Date
February 8 2023
Last Update
June 8 2025
Active Locations (18)
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1
University General Hospital of Athens "Attikon"
Athens, Attica, Greece, 12462
2
251 Air Force Hospital of Athens
Athens, Greece, 11525
3
General Hospital of Athens Gennimatas
Athens, Greece
4
Ippokrateio General Hospital of Athens
Athens, Greece