Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients
NCT04079920
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- 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.
- 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.
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Descriptive Information | |||||
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Brief Title | Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients | ||||
Official Title | BASELINE VARIABLES PREDICTING TREATMENT RESPONSE AT 6 MONTHS IN ADULT RHEUMATOID ARTHRITIS PATIENTS TREATED WITH TOFACITINIB 5MG BID IN A NON-INTERVENTIONAL SETTING (TREAT - RA) | ||||
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 aims to describe the treatment patterns of RA patients prescribed tofacitinib in a real-world setting and assess the effect of treatment on patient quality of life and physical function. Finally the study will assess the use of healthcare resources and costs in patients with RA treated with tofacitinib in Greece. 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 | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Adult patients presenting in outpatient clinics of Hospitals in Greece (secondary care) | ||||
Condition | Rheumatoid Arthritis | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment | 200 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | September 30, 2022 | ||||
Estimated Primary Completion Date | July 1, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Greece | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04079920 | ||||
Other Study ID Numbers | A3921342 TREAT-RA ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | November 2020 |