Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice

NCT04517669

Last updated date
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriatic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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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Advanced Information
Descriptive Information
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
 (submitted: August 14, 2020)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 31, 2022
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:

  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

Exclusion Criteria: 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)
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2020