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

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

An Investigation of Tofacitinib PsA Initiators in the CorEvitas SpA Registry

ClinicalTrials.gov ID

NCT05195814

Acronym / sponsor ID

A3921411

Conditions

Psoriatic Arthritis

Study type

Observational

Recruitment status

Completed

Enrolment

141 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

15 Nov 2021 (actual)

Primary completion

31 Oct 2023 (actual)

Study completion

31 Oct 2023 (actual)

First posted

19 Jan 2022 (actual)

Results

Posted 30 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Retrospective

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Participants in an existing registry database

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Change From Baseline to 6 Months in Tender Joint Count (68)

   Time frame: 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

   Tender joint count (TJC) 68 is a method of assessing joint inflammation. Number of tender joints was determined by examining 68 joints and identifying the joints that were painful under pressure or to passive motion. The joints examined included the temporomandibular (n = 2), sternoclavicular (n = 2), acromioclavicular (n = 2), shoulder (n = 2), elbow (n = 2), wrist (n = 2), metacarpophalageal (n = 10), interphalangeal of thumb (n = 2), distal interphalangeal (n = 8), proximal interphalangeal (n =8), hip (n = 2), knee (n = 2), ankle mortise (n = 2), ankle tarsus (n = 2), metatarsophalangeal (n = 10), interphalangeal of great toe (n = 2), and proximal/distal interphalangeal of the toes (n = 8). Change from baseline in TJC at 6 months after tofacitinib treatment initiation was reported in this outcome measure. Baseline was defined as the date of tofacitinib treatment initiation anytime in between 14 December 2017 to 31 August 2023.

2. Change From Baseline to 6 Months in Swollen Joint Count (66)

   Time frame: 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

   Joint swelling was defined as soft tissue swelling that was detectable along the joint margins. Swollen Joint Count (SJC) was determined by examination of 66 joints and identifying when swelling was present. The joints examined included the temporomandibular (n = 2), sternoclavicular (n = 2), acromioclavicular (n = 2), shoulder (n = 2), elbow (n = 2), wrist (n = 2), metacarpophalangeal (n = 10), interphalangeal of thumb (n = 2), distal interphalangeal (n = 8), proximal interphalangeal (n = 8), knee (n = 2), ankle mortise (n = 2), ankle tarsus (n = 2), metatarsophalangeal (n = 10), interphalangeal of great toe (n = 2), and proximal/distal interphalangeal of the toes (n = 8). Change from baseline in SJC at 6 months after tofacitinib treatment initiation was reported in this outcome measure. Baseline was defined as the date of tofacitinib treatment initiation anytime in between 14 December 2017 to 31 August 2023.

3. Percentage of Participants Achieving Minimal Disease Activity at 6 Month Follow-up Visit

   Time frame: 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

   Psoriatic arthritis participant was defined as having minimal disease activity (MDA) when participant met at least 5 of following criteria: 1) tender joint count less than or equal to (<=) 1; 2) swollen joint count <= 1; 3) body surface area (BSA) <=3%; 4) patient pain VAS on 100 mm scale <= 15; where 0= 'no pain' and 100= 'pain as severe as can be imagined', higher scores indicated greater severity; 5) patient's global activity VAS on a 100 mm scale <= 20, where 0= 'lowest level of disease activity' and 100= 'highest level of disease activity', higher scores indicated greater level of disease activity; Health Assessment Questionnaire-Disability Index (HAQ-DI) score <=0.5, scale ranged from 0-3, where 0= 'normal or no difficulty' and 3= 'inability to perform', higher scores indicated more difficulty to perform; 6) tender entheseal point <= 1 using Leed's index ranged from 0-6; where 0= 'non tender' and 6= '6 tender tendon insertions', higher scores indicated more tendon insertions.

4. Percentage of Participants With Percent Body Surface Area Score of 0% at 6 Month Follow-up Visit

   Time frame: 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

   Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10 percent (%) for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis. Percentage of participants with % BSA score of 0% at 6-month follow-up visit were reported in this outcome measure.

5. Percentage of Participants With Psoriatic Arthritis Disease Activity Score (PASDAS) Less Than (<) 3.2 at 6 Month Follow-up Visit

   Time frame: 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

   PASDAS: patient global psoriatic arthritis assessment (PAA),physician global PAA, each scored on 100mm VAS,0=no disease activity(DA), 100=maximum DA, higher scores=greater DA;TJC(0-68);SJC(0-66);Leed's Enthesitis Index score ranging from 0-6;where 0=non tender,6=6 tender tendon insertions,higher scores=more tender insertions; tender dactylitic digit score ranging from 0-3 where 0=no tenderness,3=participant withdrew digit, higher scores=more tenderness; physical component summary(PCS) of short form 12(SF-12) score ranging from 0-100;where 0-20=severe physical health(PH)limitations,21-40=significant PH issues,41-60=moderate physical health,61-80=good PH,81-100=excellent PH. PASDAS total score were transformed \& ranged from 0-10 where score 1.9 or less=remission,1.9-3.2=low disease activity(LDA),3.2-5.4=moderate DA,5.4 and higher=high DA, with higher scores indicating more severe disease. Percentage of participants with PASDAS score <3.2 (LDA) at 6-month follow-up visit were reported.

6. Percentage of Participants With Resolution of Enthesitis

   Time frame: 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

   Enthesis:site where joint capsules,ligaments,tendons attach to bone.Enthesitis is inflammation of entheses.This inflammation lead to severe pain,discomfort.Resolution of enthesitis determined by Spondyloarthritis Research Consortium of Canada(SPARCC)Enthesitis Index evaluates presence,severity of enthesitis at specific sites on body \& includes:medial epicondyle,lateral epicondyle,supraspinatus insertion into greater tuberosity of humerus,greater trochanter,quadriceps insertion into superior border of patella,patellar ligament insertion into interior pole of patella/tibial tubercle,achilles tendon insertion into calcaneum,plantar fascia insertion into calcaneum.Each site is scored based on tenderness,ranged from 0-16.Higher scores=more severe enthesitis.Enthesitis was considered as resolved in those participants who had SPARCC >0 at 6 month follow-up visit(anytime in between 3-9 months after tofacitinib initiation).Percentage of participants with resolution of enthesitis were reported.

7. Percentage of Participants With Resolution of Dactylitis

   Time frame: 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

   Dactylitis is severe inflammation of the finger or toe tendons and joints, making them look like sausages. Resolution of dactylitis can be achieved by usage of NSAIDs, local steroid injections, biologic drugs and DMARDs. Resolution in dactylitis was considered when the following criteria were met: reduction in swelling: the affected digits showed a significant decrease in swelling; pain relief: there was a notable reduction or complete absence of pain in the affected area; improved functionality: the digits regained normal function and movement; absence of tenderness: the affected area no longer exhibited tenderness upon examination. Percentage of participants with resolution of dactylitis were reported in this outcome measure.

8. Percentage of Participants Achieving Score of "Clear" or "Almost Clear" According to Investigator Global Assessment (IGA) of Psoriasis (PsO)

   Time frame: 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

   The Investigator's Global Assessment (IGA) is a tool used to assess the severity of psoriasis. It is a scale that typically ranges from 0 to 4, where 0 indicates clear skin (no signs of psoriasis), 1 indicates almost clear (minimal signs of psoriasis), 2 indicates mild psoriasis, 3 indicates moderate psoriasis and 4 indicates severe psoriasis, higher scores indicated greater severity of psoriasis and provides a subjective evaluation of the overall severity of psoriasis based on clinical signs such as erythema, induration, and scaling. Percentage of participants with score of "Clear" (score 0) or "Almost Clear" (score 1) according to IGA of PsO were reported in this outcome measure.

9. Change From Baseline at 6 Months Follow-up Visit in Disease Activity in Psoriatic Arthritis (DAPSA)

   Time frame: 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

   DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (milligram per deciliter [mg/dL]), participant assessment of pain (0 to 10 cm VAS, 0= no pain, 10= worst possible pain, higher scores indicated more pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor, higher scores indicated more disease activity). DAPSA score ranges from 0 to more than (>) 28. Where 0-4 indicates remission, 5-14 indicates low disease activity, 15-28 indicates moderate disease activity and >28 indicates high disease activity. A higher DAPSA score indicated more active disease activity.

10. Change From Baseline at 6 Months Follow-up Visit in Psoriatic Arthritis Disease Activity (PASDAS) Score

    Time frame: 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

    PASDAS is composite PsA disease activity score that included: patient global psoriatic arthritis assessment, physician global psoriatic arthritis assessment, each scored on 100 mm VAS scale where 0= "no disease activity", 100= "maximum disease activity", higher scores indicated greater disease activity; TJC (0-68); SJC (0-66); Leed's Enthesitis Index score ranging from 0-6; where 0=non tender, 6=6 tender tendon insertions, higher scores indicated more tender insertions; tender dactylitic digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit, higher scores indicated more tenderness; PCS of SF-12 score ranging from 0-100; where 0-20=severe physical health limitations, 21-40=significant physical health issues, 41-60=moderate physical health, 61-80=good physical health and 81-100=excellent physical health. PASDAS total score were transformed and ranged from 0 to 10, with higher scores indicating more severe disease.

11. Change From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Pain Score (VAS)

    Time frame: 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

    Participants self-reported assessment of the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated greater severity of pain.

12. Change From Baseline at 6 Month Follow-up Visit in Patient's Global Assessment of Fatigue Score (VAS)

    Time frame: 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

    Participants self-reported assessment of the severity of their arthritis fatigue using a 100 mm VAS by placing a mark on the scale between 0 (no fatigue) and 100 (most severe fatigue), which corresponded to the magnitude of their fatigue, where higher scores indicated greater severity of fatigue.

13. Change From Baseline at 6 Month Follow-up Visit in Investigator Global Assessment (IGA) of PsO

    Time frame: 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

    The IGA is a tool used to assess the severity of psoriasis. It is a scale that typically ranges from 0 (clear) to 4 (severe) higher scores indicated greater severity of psoriasis and provides a subjective evaluation of the overall severity of psoriasis based on clinical signs such as erythema, induration, and scaling.

14. Change From Baseline at 6 Month Follow-up Visit in Percentage Body Surface Area (BSA)

    Time frame: 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

    Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area of a body region was counted. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint = 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%. Higher % BSA = greater severity of psoriasis.

15. Change From Baseline at 6 Month Follow-up Visit in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

    Time frame: 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

    HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing or grooming; arising; eating; walking; reach; grip; hygiene; and other activities. There were total of 30 items distributed in these 8 domains. Each item was scored on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.

16. Change From Baseline at 6 Month Follow-up Visit in Percentage Work Time Missed

    Time frame: 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

    The Work Productivity and Activity Impairment (WPAI) assessed work productivity and impairment. It is a 6-item questionnaire used to assess degree to which psoriasis affected work productivity and regular activities over the past 7 days. Questions were as follows: question 1=currently employed; question 2=hours missed due to health problems; question 3=hours missed due to other reasons; question 4=hours actually worked; question 5=degree problem affected productivity while working (VAS 0-100 scale, with higher numbers indicating less productivity); question 6=degree problem affected regular activities (VAS 0-100 scale, with higher numbers indicating greater impairment of regular activities). Percent work time missed due to health problem was calculated as: question 2/ (question 2+question 4) and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity. Change from baseline in percentage work time missed at 6 month follow-up visit was reported.

17. Change From Baseline at 6 Month Follow-up Visit in Percentage Impairment While Working

    Time frame: 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

    The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which psoriasis affected work productivity and regular activities over the past 7 days. The questions are as follows: question 1 = currently employed; question 2 = hours missed due to health problems; question 3 = hours missed due to other reasons; question 4 = hours actually worked; question 5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); question 6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent impairment while working due to problem was calculated as: question 5/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity. Change from baseline in percentage impairment while working at 6 month follow-up visit was reported.

18. Change From Baseline at 6 Month Follow-up Visit in Percentage Overall Work Impairment

    Time frame: 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

    The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which psoriasis affected work productivity and regular activities over the past 7 days. The questions are as follows: question 1 = currently employed; question 2 = hours missed due to health problems; question 3 = hours missed due to other reasons; question 4 = hours actually worked; question 5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); question 6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent overall work impairment due to problem was calculated as: question 2/ (question 2+question 4) + [(1- question 2/ (question 2+question 4) * (Q5/10)] and score ranged from 0-100% where higher numbers indicate greater impairment. Change from baseline in percentage overall work impairment at 6 month follow-up visit was reported.

19. Change From Baseline at 6 Month Follow-up Visit in Percentage Activity Impairment

    Time frame: 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

    The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which psoriasis affected work productivity and regular activities over the past 7 days. The questions are as follows: question 1 = currently employed; question 2 = hours missed due to health problems; question 3 = hours missed due to other reasons; question 4 = hours actually worked; question 5 = degree health affected productivity while working (0-10 scale, with higher numbers indicating less productivity); question 6 = degree health affected regular activities (0-10 scale, with higher numbers indicating greater impairment of regular activities). Percent activity impairment due to problem was calculated as: question 6/10 and score ranged from 0-100% where higher numbers indicate greater impairment. Change from baseline in percentage activity impairment at 6 month follow-up visit was reported.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 41343116Ogdie A, Middaugh N, Blachley T, Bourgeois T, Ling YL, Mundayat R, Fallon L, Masri KR, Mease PJ. Effectiveness of Tofacitinib in Patients with Psoriatic Arthritis Initiating Monotherapy Versus Combination Therapy: Results from the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. Rheumatol Ther. 2026 Feb;13(1):195-212. doi: 10.1007/s40744-025-00811-4. Epub 2025 Dec 4.
• Derived from this study: PubMed 38252211Mease PJ, Young P, Fallon L, Mundayat R, Dina O, Blachley T, Middaugh N, Ogdie A. Effectiveness of Tofacitinib in Patients Initiating Therapy for Psoriatic Arthritis: Results from the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. Rheumatol Ther. 2024 Apr;11(2):313-329. doi: 10.1007/s40744-023-00631-4. Epub 2024 Jan 22.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.
• Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.