Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice
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| ClinicalTrials.gov Identifier: NCT04517669 |
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Recruitment Status :
Recruiting
First Posted : August 18, 2020
Last Update Posted : May 18, 2023
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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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
| Condition or disease |
|---|
| Psoriatic Arthritis |
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 12 Months |
| Official Title: | A Non-Interventional Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis |
| Actual Study Start Date : | May 17, 2021 |
| Estimated Primary Completion Date : | June 30, 2023 |
| Estimated Study Completion Date : | June 30, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Psoriatic arthritis
Primary Outcome Measures :
- Proportion of patients achievinglow disease activity (LDA) defined as psoriatic arthritis disease activity score (PASDAS) score ≤3.2 [ Time Frame: at 6 months ]
Secondary Outcome Measures :
- Proportion of patients achieving low disease activity (LDA) defined as psoriatic arthritis disease activity score (PASDAS) score ≤3.2 [ Time Frame: at 3 and 12 Months ]
- Proportion of patients achieving minimal disease activity (MDA) defined as at least 5 of 7 criteria met [ Time Frame: Months 3, 6, 12 ]
- Proportion of patients achieving remission defined as psoriatic arthritis disease activity score (PASDAS) score ≤1.9 [ Time Frame: Months 3, 6, 12 ]
- Proportion of patients achieving remission defined as disease activity in psoriatic arthritis (DAPSA) score ≤4.0 [ Time Frame: Months 3, 6,12 ]
- Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID12) score [ Time Frame: Months 3, 6,12 ]
- Change from baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) score [ Time Frame: Months 3, 6,12 ]
- Proportion of patients achieving low disease activity (LDA) at Months 3, 6, and 12 based on presence of prognostic factors [ Time Frame: Months 3, 6, 12 ]
- Change from baseline in quality of life (QoL) using Patient reported outcomes (PRO ) scores [ Time Frame: Months 3, 6,12 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Patients aged ≥ 18 years
- Moderate to severe PsA disease activity diagnosed
- 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
- Patients are treatment naïve to tofacitinib on the date of providing informed consent
- 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 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:
- Contraindications according to the Xeljanz® (tofacitinib) Prescribing Information
- Receipt of any investigational drug within 3 months before study inclusion
- Patient is pregnant or breastfeeding
- Recent herpes zoster infection (within past 6 months) or history of severe disseminated herpes zoster infection
- Active treatment for a malignancy
- Concomitant treatment with a biological disease-modifying antirheumatic drugs (bDMARD)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517669
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Locations
Show 33 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT04517669 |
| Other Study ID Numbers: |
A3921332 TOPSATI ( Other Identifier: Alias Study Number ) |
| First Posted: | August 18, 2020 Key Record Dates |
| Last Update Posted: | May 18, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (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/data_requests. |
Additional relevant MeSH terms:
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Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis |
Spondylitis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases |