Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice

September 24, 2025 updated by: Pfizer

A Non-Interventional Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis

This is a Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis in order to evaluate the effectiveness of treatment with tofacitinib on disease activity, remission, and Quality of Life, in a real-world setting over a 12-month observation period

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Algemeen Stedelijk Ziekenhuis
      • Bruges, Belgium, 8000
        • AZ Sint-Jan
      • Genk, Belgium, 3600
        • Nova Reuma Społka Partnerska
  • Denmark
      • Hjørring, Denmark
        • Sygehus Vendsyssel Hospital
  • Finland
      • Turku, Finland
        • Turku University Hospital
  • France
      • Besançon, France, 25000
        • CHU Besançon - Hôpital Jean Minjoz
      • Cahors, France, 46000
        • Centre Hospitalier Jean Rougier
      • Caluire-et-Cuire, France, 69300
        • Infirmerie Protestante de Lyon
      • Clermont-Ferrand, France, 63000
        • CHU Clermont Ferrand - Hopital Gabriel Montpied
      • Nice, France, 6001
        • Hôpital Pasteur
      • Orléans, France, 45067
        • CHR ORLEANS
      • Toulouse, France, 31059
        • Hopital Purpan
      • Tours, France, 37044
        • CHU Tours - Hôpital Trousseau
  • Israel
      • Ashkelon, Israel
        • Barzilai Medical Center
      • Beersheba, Israel, 84001
        • Soroka university medical center
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Haifa, Israel, 3436212
        • The Lady Davis Carmel Medical Center
      • Haifa, Israel
        • Rambam Health Care Center
      • Jerusalem, Israel, 246000
        • Hadassah University Hospital - Ein Kerem
      • Jerusalem, Israel, 91120
        • Hadassah Hebrew University Medical Center - Ein Kerem
      • Nahariya, Israel
        • Galilee Medical Center
      • Ramat Gan, Israel, 52621
        • Chaim Sheba Medical Center
      • Ramat Gan, Israel
        • Sheba Medical Center
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
      • Tiberias, Israel, 15208
        • The Baruch Padeh Medical Center - Poriya
  • Netherlands
      • Enschede, Netherlands, 7512 KZ
        • Medisch Spectrum Twente, Haaksbergerstraat
      • Leeuwarden, Netherlands
        • Medisch Centrum Leeuwarden
  • Spain
      • Cadiz, Spain, 11009
        • Hospital Universitario Puerta Del Mar
      • Cadiz, Spain, 11407
        • Hospital de Especialidades de Jerez de La Frontera
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Granada, Spain, 18012
        • Hospital Universitario San Cecilio
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Málaga
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Seville, Spain, 41010
        • Hospital Quironsalud Infanta Luisa
    • Galicia
      • Vigo, Galicia, Spain, 36200
        • C.H. Universitario de Vigo- Hospital Meixoeiro
  • Sweden
      • Lund, Sweden
        • Lund University
      • Malmo, Sweden
        • Skånes Universitetssjukhus, Malmö
      • Stockholm, Sweden
        • Karolinska University Hospital, Solna
      • Umeå, Sweden
        • Norrlands University Hospital Umeå, Reumatologiska kliniken Västerbotten

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study will enroll approximately 500 patients from rheumatologists and/or PsA specialist centers in 10 countries (Belgium, Czech Republic, Denmark, Finland, France, Israel, Netherlands, Spain, Sweden, and Switzerland) over an enrollment period of 12 months. The above list of countries are anticipated to participate in this study, however additional countries may be included at a later time. Each patient will have up to 12 months of follow-up for a total study duration of 24 months. Consecutive patients attending a routine clinical visit will be invited to participate if they meet the eligibility criteria for the study and are to start on treatment with tofacitinib for active PsA.

Description

Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. Patients aged ≥ 18 years
  2. Moderate to severe PsA disease activity diagnosed
  3. Patients for whom the physician's decision has been made to initiate treatment with tofacitinib, in usual clinical practice conditions and in compliance with the local label
  4. Patients are treatment naïve to tofacitinib on the date of providing informed consent
  5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
  6. Patients on DMARDs must have not had a treatment change in the past 3 months

Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study:

  1. Contraindications according to the Xeljanz® (tofacitinib) Prescribing Information
  2. Receipt of any investigational drug within 3 months before study inclusion
  3. Patient is pregnant or breastfeeding
  4. Recent herpes zoster infection (within past 6 months) or history of severe disseminated herpes zoster infection
  5. Active treatment for a malignancy
  6. Concomitant treatment with a biological disease-modifying antirheumatic drugs (bDMARD)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Low Disease Activity (LDA) Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6
Time Frame: At Month 6
PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global psoriatic arthritis assessment (PAA), physician global PAA, each scored on 100 mm visual analog scale (VAS), 0=no disease activity (DA), 100=maximum DA; tender joint count (TJC) (0-68); swollen joint count (SJC) (0-66); Leed's Enthesitis index (LEI) score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; physical component summary (PCS) of short form 36 (SF-36) score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. LDA was defined as PASDAS score less than or equal to (<=) 3.2.
At Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12
Time Frame: At Month 3 and Month 12
PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. LDA was defined as PASDAS score less than or equal to (<=) 3.2.
At Month 3 and Month 12
Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
A participant was classified as MDA achieved if they met 5 of 7 criteria: (i) (TJC66) <=1, (ii) (SJC68)<=1, (iii) psoriasis area and severity index (PASI) score <=1 (PASI=combined assessment of lesion severity and area affected into single score; range=0 [no disease] to 72 [maximal disease], higher scores=more disease. or body surface area (BSA) <=3%,(iv) patient pain assessment (VAS, 0-100) <=15; where 0='no pain' and 100='pain as severe as can be imagined', higher scores=more pain, (v) patient global assessment (VAS, 0-100) <=20, where 0='lowest level of disease activity' and 100= 'highest level of disease activity, higher scores=more disease activity, (vi) health assessment questionnaire-disability index (HAQ- DI) <=0.5; scale ranged=0-3, where 0='normal or no difficulty' and 3='inability to perform', higher scores=more difficulty, (vii) tender enthesial points <=1 using Leed's index range=0=non tender to 6=more enthesitis burden, higher scores=more burden.
At Month 3, Month 6 and Month 12
Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. Remission was defined as PASDAS score less than or equal to (<=) 1.9.
At Month 3, Month 6 and Month 12
Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
DAPSA was composite disease activity measure and was calculated as: SJC66 + TJC68 + patient global assessment VAS (0 to 10 cm VAS, 0= excellent and 10= poor, higher scores indicated more disease activity) + patient pain assessment (0 to 10 cm VAS, 0= no pain, 10= worst possible pain, higher scores indicated more pain) + CRP (mg/dL). DAPSA score ranged from 0 to 164, higher scores indicated more disease activity. Remission was defined as DAPSA score =<4.0.
At Month 3, Month 6 and Month 12
Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12
Time Frame: Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12
PsAID12: questionnaire used for evaluating how much PsA impacted quality of life (QoL) and comprised of following domains: Pain, Fatigue, Skin problems, Work and/or leisure activities, Function, Discomfort, Sleep disturbance, Coping, Anxiety, Embarrassment, Social life and Depression. Each one of domain was based on a 0-10 numerical rating scale (NRS) and with different weight. PsAID12= (PsAID12.Q1 [pain] NRS value*3) +(PsAID12.Q2[fatigue] NRS value*2) +(PsAID12.Q3 [skin] NRS value*2) +(PsAID12.Q4[Work and/or leisure activities] NRS value*2) +(PsAID12.Q5[function] NRS value*2) +(PsAID12.Q6[discomfort]NRS value*2) +(PsAID12.Q7[sleep] NRS value*2) +(PsAID12.Q8 [coping]NRS value*1) +(PsAID12.Q9[anxiety] NRS value*1) +(PsAID12.Q10[embarrassment] NRS value*1) +(PsAID12.Q11[social life] NRS value*1) +(PsAID12.Q12[depression] NRS value*1). Total is divided by 20 for final score. Range of final PsAID score is 0-10 (higher numbers indicate worse status).
Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12
Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12
Time Frame: Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12
The SPARCC-EI evaluated 16 enthesial sites: greater trochanter (Right/Left [R/L]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial epicondyles (R/L), lateral epicondyles (R/L) and supraspinatus insertion (R/L) for the presence or absence of tenderness. Tenderness at each site was quantified as: 0 = non-tender and 1 = tender. The maximum score of the SPARCC-EI was 16. SPARCC-EI score range: 0 (no enthesitis) to 16 (enthesitis is present at all assessed sites), higher scores indicated more presence of enthesitis.
Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
BMI = Weight (kilograms [kg]) / Height (meter square [m]^2). LDA was defined as PASDAS score =<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. In this outcome measure, participants with PASDAS scores are reported according to BMI categories of 18.5 - <25 kg/m^2, 25 - <30 kg/m^2, >= 30 kg/m^2 and missing.
At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
Participants who achieved LDA according to treatment line were reported in this outcome measure. Treatment line included: tofacitinib monotherapy, combination therapy with MTX, and combination therapy with other csDMARDs. LDA was defined as PASDAS score =<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
Duration of current episode of symptoms prior to enrollment were presented as: < 6, >=6 weeks. LDA was defined as PASDAS score =<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
ESR result=abnormal if test result was above normal range. ESR normal range:0-50 years(male <15 mm/h, female <20 mm/h), 51-85 years(<20 mm/h males and <30 mm/h females),older than 85 years(<30 mm/h males and <42 mm/h females). Number of participants who achieved LDA according to ESR results(normal and abnormal) were reported. LDA=PASDAS score =<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following:participant global PAA,physician global PAA,each scored on 100 mm VAS,0=no DA, 100=maximum DA; TJC(0-68); SJC(0-66); LEI score=0-6;0=non tender,6=more enthesitis burden; tender dactylitis digit score=0-3,0=no tenderness,3=participant withdrew digit; PCS of SF-36 score=0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged=0(no disease)to 10(severe disease);higher scores=more severe disease.
At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
For CRP, result was considered abnormal if t the test result was above the normal range (0.3 to 10 mg/L). LDA was defined as PASDAS score =<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
Number of participants who achieved LDA according to presence (present/absent) of rheumatoid nodules is presented in this outcome measure. LDA was defined as PASDAS score =<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
Unequivocal radiological erosion: 'present',if Sharp-Van der Heijde modified score (S-VH MS)for erosion >0;'absent',if S-VH MS for erosion score=0. S-VH MS sum of erosion,JSN scores(range 0-528). Higher score=more severe disease. If a component score is missing, S-VH MS is missing. LDA=PASDAS score =<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA,physician global PAA,each scored on 100 mm VAS,0=no DA,100=maximum DA; TJC(0-68); SJC(0-66); LEI score range=0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score range=0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score range=0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0(no disease)to 10(severe disease); higher scores=more severe disease.
At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
Unequivocal Bony decalcification was reported as present or absent at enrollment. LDA was defined as PASDAS score =<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
Arthritis at enrollment was identified when a participant reported swelling and/or tenderness/pain in any joint. Number of participants who achieved LDA according to presence (Yes/No) of symmetric arthritis was reported. LDA was defined as PASDAS score =<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC (0-68); SJC (0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
Hand joints included metacarpal phalangeal joints(MCP), finger proximal interphalangeal and finger distal interphalangeal joints. Number of participants who achieved LDA according to presence(Yes/No) of arthritis of any of hand joints was reported. LDA=PASDAS score =<3.2. PASDAS=composite disease activity measure for PsA which incorporated assessment of following: participant global PAA,physician global PAA, each scored on 100 mm VAS,0=no DA,100=maximum DA;TJC(0-68); SJC(0-66); LEI score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease.
At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
Medium joints=temporomandibular, sternoclavicular, acromioclavicular, finger proximal interphalangeal, finger distal interphalangeal and tarsus/midfoot(feet) joints. Large joints=glenohumeral, elbows, hips, knees and ankles joint. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of only 1 medium-large joint was reported. LDA=PASDAS score =<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA;TJC(0-68);SJC(0-66); LEI score ranging from 0-6;0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3;0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100;0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS score (0-10) uses a weighted formula; higher scores=more severe disease.
At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
Medium joints=temporomandibular, sternoclavicular, acromioclavicular, finger proximal interphalangeal (IP), finger distal interphalangeal, tarsus/midfoot (feet). Large joints=glenohumeral, elbows, hips, knees, ankles. Small joints=MCP, proximal IP, second through fifth metatarsal phalangeal (MTP), thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) arthritis of 2-10 medium-large joints and/or 1-3 small joints was reported. LDA=PASDAS score =<3.2. PASDAS is a composite PsA activity score including: participant /physician global (VAS 0-100; 0=no DA, 100=maximum DA), TJC (0-68), SJC (0-66), LEI (0-6; 0=non tender, 6=more enthesitis burden), tender dactylitis digit score (0-3; 0=no tenderness, 3=participant withdrew digit), SF-36 PCS (0-100; 0=severe physical health limitations, 100=excellent physical health),CRP in mg/L. PASDAS score (0-10) uses a weighted formula; higher scores=more severe disease.
At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
Large joints=glenohumeral, elbows, hips, knees and ankles joint. Small joints=MCP, proximal IP, second through fifth MTP, thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of 4-10 small joints with or without involvement of large joints was reported. LDA=PASDAS score =<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA;TJC(0-68); SJC(0-66); LEI score range=0-6; 0=non tender, 6=more enthesitis burden; tender dactylitis digit score range=0-3; 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores=more severe disease.
At Month 3, Month 6 and Month 12
Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12
Time Frame: At Month 3, Month 6 and Month 12
Small joints=MCP, proximal IP, second through fifth MTP, thumb IP, wrists. Number of participants who achieved LDA according to presence (Yes/No) of arthritis of >10 joints (with at least one small joint) was reported in this outcome measure. LDA=PASDAS score =<3.2. PASDAS=composite disease activity measure for PsA incorporated assessment of: participant global PAA, physician global PAA, each scored on 100 mm VAS, 0=no DA, 100=maximum DA; TJC(0-68); SJC(0-66); LEI score ranging from 0-6; 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3; 0=no tenderness, 3=participant withdrew digit; PCS of SF-36 score ranging from 0-100; 0=severe physical health limitations and 100=excellent physical health and CRP in mg/L. PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores=more severe disease.
At Month 3, Month 6 and Month 12
Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12
Time Frame: Baseline (measurement at enrollment), Month 3, Month 6 and Month 12
The SF-36 is a participant administered scale assessing general quality of life. It consists of self-administered 36-item questionnaire that measured 8 health domains: physical function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. These 8 domains are also summarized as physical and mental component scores. The score for each domain and component score is the mean of the individual question scores, which are scaled from 0 (minimum) to 100 (maximum), where high scores in each dimension and high overall scores indicate a better quality of life.
Baseline (measurement at enrollment), Month 3, Month 6 and Month 12
Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12
Time Frame: Baseline (measurement at enrollment), Month 3, Month 6 and Month 12
The HAQ-DI41 assessed the degree of difficulty a participant had 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 consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 =no difficulty," 1 = "some difficulty," 2 = "much difficulty," and 3 = "unable to do". The disability index was computed by adding the scores for each of the components and dividing by the number of components with an available score. 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.
Baseline (measurement at enrollment), Month 3, Month 6 and Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3921332
  • TOPSATI (Other Identifier: Alias Study Number)

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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