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

Completed

• Conditions: Psoriatic Arthritis

• Registration Number: NCT04517669
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2020-08-14
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-18
• Study Start: 2021-05-17
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients achievinglow disease activity (LDA) defined as psoriatic arthritis disease activity score (PASDAS) score ≤3.2	at 6 months

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving remission defined as psoriatic arthritis disease activity score (PASDAS) score ≤1.9	Months 3, 6, 12
Proportion of patients achieving low disease activity (LDA) defined as psoriatic arthritis disease activity score (PASDAS) score ≤3.2	at 3 and 12 Months
Proportion of patients achieving minimal disease activity (MDA) defined as at least 5 of 7 criteria met	Months 3, 6, 12
Proportion of patients achieving remission defined as disease activity in psoriatic arthritis (DAPSA) score ≤4.0	Months 3, 6,12
Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID12) score	Months 3, 6,12
Change from baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) score	Months 3, 6,12
Proportion of patients achieving low disease activity (LDA) at Months 3, 6, and 12 based on presence of prognostic factors	Months 3, 6, 12
Change from baseline in quality of life (QoL) using Patient reported outcomes (PRO ) scores	Months 3, 6,12

Trial Locations

Locations (50)

Algemeen Stedelijk Ziekenhuis; 🇧🇪 Aalst, Belgium

AZ Sint-Jan; 🇧🇪 Brugge, Belgium

Nova Reuma Społka Partnerska; 🇧🇪 Genk, Belgium

Sygehus Vendsyssel Hospital; 🇩🇰 Hjørring, Denmark

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Pohjois-Kymen sairaala; 🇫🇮 Joensuu, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

CHU Besançon - Hôpital Jean Minjoz; 🇫🇷 Besancon, France

Centre Hospitalier Jean Rougier; 🇫🇷 Cahors, France

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