A Study to Learn About the Study Medicine (Called Tofacitinib) in People With Psoriatic Arthritis

An Investigation of Tofacitinib PsA Initiators in the CorEvitas SpA Registry

The purpose of this study is to learn about the safety and effects of the study medicine for the potential treatment of Psoriatic Arthritis (PsA). Psoriatic Arthritis is a joint swelling disease that can also affect the skin, nails and eyes. The study medicine is called Tofacitinib. This study is seeking participants who:

• Started taking tofacitinib alone or with other approved medicines (eg. methotrexate, leflunomide, sulfasalazine, apremilast) for PsA disease. We will only look at participants' who started tofacitinib after December 14, 2017.
• Have a 6-month follow-up visit (with a 3-month window) This is an observational study. Participants receiving Tofacitinib will be included to assess how well tofacitinib works. We will look at participants' demographic information and therapy history. We will also monitor participants' disease progression before and 6 months after treatment. We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis

Detailed Description

Tofacitinib is an oral Janus kinase (JAK) inhibitor approved in 2017 by the US Food and Drug Administration (FDA) for the treatment of adult patients with active PsA who have had an inadequate response or intolerance to methotrexate or other disease modifying antirheumatic drugs (DMARDs). As of December 3, 2021, Tofacitinib is approved for use in patients who have had an inadequate response or intolerance to one or more TNF blockers.

This is an observational retrospective cohort study that will be conducted using patients enrolled in the CorEvitas PsA/SpA Registry, initiating tofacitinib on or after December 14th, 2017. Patients receiving tofacitinib will be included to assess the effectiveness of tofacitinib overall and when stratified by key variables of interest. More specifically, the overall aim will be to describe baseline demographic, therapy history, and disease activity characteristics and assess change in disease activity measures six months after initiation of tofacitinib.

There are two primary objectives for this study:

1. To describe the effectiveness of all tofacitinib initiators at 6 months in PsA patients
2. To describe the effectiveness of all tofacitinib initiators at 6 months stratified by monotherapy and combination therapy of PsA

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants in an existing registry database

Description

Inclusion Criteria:

• PsA patients in CorEvitas initiating tofacitinib monotherapy or in combination with oral small molecules (eg methotrexate, leflunomide, sulfasalazine, apremilast) after 14 December 2017 (market approval of tofacitinib in the US) with no prior use of tofacitinib. Only the patient's first initiation after December 14, 2017 will be included in the analysis
• Have a 6 month follow-up visit (with ±3 month window)

Exclusion Criteria:

• Patients taking tofacitinib in combination with any other bDMARD

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Effectiveness of tofacitinib; Participants receiving tofacitinib will be included to assess the effectiveness of tofacitinib overall and stratified by key variables of interest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in number of patients achieving low disease activity as defined by the clinical Disease Activity index for Psoriatic Arthritis (cDAPSA) score	The clinical disease activity index for Psoriatic Arthritis (cDAPSA) is a composite score that includes swollen and tender joints (66/68), Patient Global assessment of disease activity (PtGA VAS), and Patient assessment of Pain (Pt Pain VAS). Low disease activity is a cDAPSA score <4	Baseline, Month 6
Change from baseline in number of patients achieving Minimal Disease Activity	A psoriatic arthritis patient is defined as having Minimal Disease Activity (MDA)26 when the patient meets at least 5 of the 7 following criteria: 1) tender joint count at least 1; 2) swollen joint count at least 1; 3) PASI score at least 1 or BSA; 4) patient Arthritis Pain (VAS) 15; 5) patient's global arthritis assessment (VAS) 20; HAQ-DI score 0.5; 6) tender entheseal points (using Leed's Index)	Baseline, Month 6
Change from baseline in number of patients achieving a Body Surface Area (BSA) score of 0	Body Surface Area (BSA) is scored as the percentage body area affected by psoriasis; 0-100%	Baseline, Month 6
Change from Baseline in clinical Disease Activity index for Psoriatic Arthritis (cDAPSA) score	The clinical disease activity index for Psoriatic Arthritis (cDAPSA) is a composite score that includes swollen and tender joints (66/68), Patient Global assessment of disease activity (PtGA VAS), and Patient assessment of Pain VAS).	Baseline, Month 6
Change from Baseline in Disease Activity index for Psoriatic Arthritis (DAPSA) score	The clinical disease activity index for Psoriatic Arthritis (cDAPSA) is a composite score that includes swollen and tender joints (66/68), Patient Global assessment of disease activity (PtGA VAS), and Patient assessment of Pain VAS).	Baseline, Month 6
Change from Baseline in Psoriatic Arthritis Disease Activity (PASDAS) score	The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite PsA disease activity score that includes: patient global psoriatic arthritis assessment (VAS), physician global psoriatic arthritis assessment (VAS), swollen and tender joint counts (66/68), Leed's Enthesitis Index score, tender dactylitic digit score, physical component summary score (PCS) of the SF-36 and CRP	Baseline, Month 6
Change from Baseline in Health Assessment Questionnaire-Disability index (HAQ-DI) score	The Health Assessment Questionnaire-Disability Index (HAQ-DI) assesses the degree of difficulty a subject has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status	Baseline, Month 6
Change from Baseline in Body Surface Area (BSA)	Body Surface Area (BSA) is scored as the percentage body area affected by psoriasis; 0-100%	Baseline, Month 6
Change from Baseline in Clinical Disease Activity index (CDAI) score	CDAI is the numerical sum of 4 outcome parameters: tender joint count and swollen joint count based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 to 10 cm VAS; CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.	Baseline, Month 6
Change from Baseline in patient's global skin assessment score (VAS)	Patient self-reported assessment of their disease using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (excellent) and 100 (poor). The rating corresponds to the way in which the subject felt over the past week in terms of how they were affected by their psoriasis only	Baseline, Month 6
Change from Baseline in patient's global assessment of pain score (VAS)	Patient self-reported assessment of the severity of their arthritis pain using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain	Baseline, Month 6
Change from Baseline in patient's global assessment of fatigue score (VAS)	Patient self-reported assessment of the severity of their arthritis fatigue using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no fatigue) and 100 (most severe fatigue), which corresponds to the magnitude of their fatigue	Baseline, Month 6

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: A3921411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.