Clinical trial NCT05195814: A Study to Learn About the Study Medicine (Called Tofacitinib) in People With Psoriatic Arthritis
Official title: An Investigation of Tofacitinib PsA Initiators in the CorEvitas SpA Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in an existing registry database

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to 6 Months in Tender Joint Count (68)
timeFrame: Baseline, 6 months after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study
measure: Change From Baseline to 6 Months in Swollen Joint Count (66)
timeFrame: Baseline, 6 months after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study
measure: Percentage of Participants Achieving Minimal Disease Activity at 6 Month Follow-up Visit
timeFrame: 6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational study
measure: Percentage of Participants With Percent Body Surface Area Score of 0% at 6 Month Follow-up Visit
timeFrame: 6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational study
measure: Percentage of Participants With Psoriatic Arthritis Disease Activity Score (PASDAS) Less Than (<) 3.2 at 6 Month Follow-up Visit
timeFrame: 6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational study
measure: Percentage of Participants With Resolution of Enthesitis
timeFrame: 6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational study
measure: Percentage of Participants With Resolution of Dactylitis
timeFrame: 6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational study
measure: Percentage of Participants Achieving Score of "Clear" or "Almost Clear" According to Investigator Global Assessment (IGA) of Psoriasis (PsO)
timeFrame: 6 month follow-up visit (anytime in between 3 to 9 months after tofacitinib initiation); data collected and evaluated over 23.5 months in this retrospective observational study
measure: Change From Baseline at 6 Months Follow-up Visit in Disease Activity in Psoriatic Arthritis (DAPSA)
timeFrame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study
measure: Change From Baseline at 6 Months Follow-up Visit in Psoriatic Arthritis Disease Activity (PASDAS) Score
timeFrame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study
measure: Change From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Pain Score (VAS)
timeFrame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study
measure: Change From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Fatigue Score (VAS)
timeFrame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study
measure: Change From Baseline at 6 Month Follow-up Visit in Investigator Global Assessment (IGA) of PsO
timeFrame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study
measure: Change From Baseline at 6 Month Follow-up Visit in Percentage Body Surface Area (BSA)
timeFrame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study
measure: Change From Baseline at 6 Month Follow-up Visit in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study
measure: Change From Baseline at 6 Month Follow-up Visit in Percentage Work Time Missed
timeFrame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study
measure: Change From Baseline at 6 Month Follow-up Visit in Percentage Impairment While Working
timeFrame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study
measure: Change From Baseline at 6 Month Follow-up Visit in Percentage Overall Work Impairment
timeFrame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study
measure: Change From Baseline at 6 Month Follow-up Visit in Percentage Activity Impairment
timeFrame: Baseline, 6 months follow-up visit after tofacitinib initiation (anytime in between 3 to 9 months); data collected and evaluated for over 23.5 months in this retrospective observational study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: