Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients
NCT ID: NCT04079920
Last Updated: 2025-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
198 participants
OBSERVATIONAL
2020-09-22
2023-02-08
Brief Summary
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The planned recruitment period is 12 months. The planned observation period of each patient is 12 months. In this time period up to 4 visits will be documented.
The study will be reviewed and approved by the Central Regulatory Committee for NIS and IRB Board of each participating site
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University General Hospital of Athens "Attikon"
Athens, Attica, Greece
251 Air Force Hospital of Athens
Athens, , Greece
General Hospital of Athens Gennimatas
Athens, , Greece
Ippokrateio General Hospital of Athens
Athens, , Greece
Laiko General Hospital of Athens
Athens, , Greece
Naval Hospital of Athens
Athens, , Greece
Nearchou 18
Crete, , Greece
Univerisity General Hospital of Heraklion
Heraklion, , Greece
University General Hospital of Ioannina
Ioannina, , Greece
KAT General Hospital of Attica
Kfisia, , Greece
Univerisity General Hospital of Larisa
Larissa, , Greece
Univerisity General Hospital of Larisa
Larissa, , Greece
University General Hospital of Patras
Pátrai, , Greece
Agios Andreas General Hospital of Patra
Pátrai, , Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki, , Greece
Euromedica Kyanous Stavros General Clinic
Thessaloniki, , Greece
General Hospital of Thessaloniki Ippokrateio
Thessaloniki, , Greece
Asklipieio General Hospital of Voula
Voula, , Greece
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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TREAT-RA
Identifier Type: OTHER
Identifier Source: secondary_id
A3921342
Identifier Type: -
Identifier Source: org_study_id
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