Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice
NCT04517669
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
1. Patients aged ≥ 18 years
2. Moderate to severe PsA disease activity diagnosed
3. Patients for whom the physician's decision has been made to initiate treatment with tofacitinib, in usual clinical practice conditions and in compliance with the local label
4. Patients are treatment naïve to tofacitinib on the date of providing informed consent
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
6. Patients on DMARDs must have not had a treatment change in the past 3 months
Patients meeting any of the following criteria will not be included in
the study:
1. Contraindications according to the Xeljanz® (tofacitinib) Prescribing Information
2. Receipt of any investigational drug within 3 months before study inclusion
3. Patient is pregnant or breastfeeding
4. Recent herpes zoster infection (within past 6 months) or history of severe
disseminated herpes zoster infection
5. Active treatment for a malignancy
6. Concomitant treatment with a biological disease-modifying antirheumatic drugs (bDMARD)
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Descriptive Information | |||||
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Brief Title | Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice | ||||
Official Title | A Non-Interventional Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis | ||||
Brief Summary | This is a Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis in order to evaluate the effectiveness of treatment with tofacitinib on disease activity, remission, and Quality of Life, in a real-world setting over a 12-month observation period | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||
Target Follow-Up Duration | 12 Months | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | This study will enroll approximately 500 patients from rheumatologists and/or PsA specialist centers in 10 countries (Belgium, Czech Republic, Denmark, Finland, France, Israel, Netherlands, Spain, Sweden, and Switzerland) over an enrollment period of 12 months. The above list of countries are anticipated to participate in this study, however additional countries may be included at a later time. Each patient will have up to 12 months of follow-up for a total study duration of 24 months. Consecutive patients attending a routine clinical visit will be invited to participate if they meet the eligibility criteria for the study and are to start on treatment with tofacitinib for active PsA. | ||||
Condition | Psoriatic 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 | Not yet recruiting | ||||
Estimated Enrollment | 500 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | April 30, 2023 | ||||
Estimated Primary Completion Date | August 31, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study:
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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 | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04517669 | ||||
Other Study ID Numbers | A3921332 TOPSATI ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product | Not Provided | ||||
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 | March 2021 |