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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05195814
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriatic Arthritis
Study Website: View Trial Website
Additional Details

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

Arms & Interventions

Arms

: Effectiveness of tofacitinib

Participants receiving tofacitinib will be included to assess the effectiveness of tofacitinib overall and stratified by key variables of interest

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Pfizer, New York, New York

Status

Recruiting

Address

Pfizer

New York, New York, 10017

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