N/A
N=141
A Study to Learn About the Study Medicine (Called Tofacitinib) in People With Psoriatic Arthritis
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT05195814 ↗Enrolled (actual)
141
Serious AEs
—
Results posted
Mar 2025
Primary outcome: Primary: Change From Baseline to 6 Months in Tender Joint Count (68) — -2.5; -3.2; -2.0 Tender joints
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 6 Months in Tender Joint Count (68) |
-2.5; -3.2; -2.0 | — |
| PRIMARY Change From Baseline to 6 Months in Swollen Joint Count (66) |
-1.6; -2.2; -1.1 | — |
| PRIMARY Percentage of Participants Achieving Minimal Disease Activity at 6 Month Follow-up Visit |
17.8; 15.0; 20.7 | — |
| PRIMARY Percentage of Participants With Percent Body Surface Area Score of 0% at 6 Month Follow-up Visit |
24.7; 27.1; 22.0 | — |
| PRIMARY Percentage of Participants With Psoriatic Arthritis Disease Activity Score (PASDAS) Less Than (<) 3.2 at 6 Month Follow-up Visit |
21.8; 21.1; 22.5 | — |
| PRIMARY Percentage of Participants With Resolution of Enthesitis |
35.2; 33.3; 36.7 | — |
| PRIMARY Percentage of Participants With Resolution of Dactylitis |
27.8; 28.6; 27.3 | — |
| PRIMARY Percentage of Participants Achieving Score of "Clear" or "Almost Clear" According to Investigator Global Assessment (IGA) of Psoriasis (PsO) |
27.8; 28.6; 26.9 | — |
| PRIMARY Change From Baseline at 6 Months Follow-up Visit in Disease Activity in Psoriatic Arthritis (DAPSA) |
-7.2; -10.7; -4.9 | — |
| PRIMARY Change From Baseline at 6 Months Follow-up Visit in Psoriatic Arthritis Disease Activity (PASDAS) Score |
-1.1; -1.3; -1.0 | — |
| PRIMARY Change From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Pain Score (VAS) |
-8.9; -13.7; -4.7 | — |
| PRIMARY Change From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Fatigue Score (VAS) |
-5.9; -10.8; -1.6 | — |
| PRIMARY Change From Baseline at 6 Month Follow-up Visit in Investigator Global Assessment (IGA) of PsO |
-0.3; -0.3; -0.2 | — |
| PRIMARY Change From Baseline at 6 Month Follow-up Visit in Percentage Body Surface Area (BSA) |
-0.7; -1.7; 0.2 | — |
| PRIMARY Change From Baseline at 6 Month Follow-up Visit in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |
-0.1; -0.1; 0.0 | — |
| PRIMARY Change From Baseline at 6 Month Follow-up Visit in Percentage Work Time Missed |
-1.9; -6.1; 2.5 | — |
| PRIMARY Change From Baseline at 6 Month Follow-up Visit in Percentage Impairment While Working |
-6.3; -12.7; 0.1 | — |
| PRIMARY Change From Baseline at 6 Month Follow-up Visit in Percentage Overall Work Impairment |
-6.0; -13.0; 1.4 | — |
| PRIMARY Change From Baseline at 6 Month Follow-up Visit in Percentage Activity Impairment |
-12.1; -21.8; -2.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05195814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.